Primary Services About the President Experience Chemistries Improved and/or Developed Products Manufactured and/or Developed Partial Client List Patents, Publications And Quotations Testimonials & Book Reviews Contact Us

Patents, Publications, Presentations and Quotations [Printable Version] IF ANY URL DOES NOT WORK, PLEASE CONTACT AT GIRISH@EPCOTINT.COM FOR ASSISTANCE. US Patent # 4,269,987 issued on May 26, 1981 Numerous technology innovations disclosed and not filed to protect inventions. Malhotra, Girish; Continuous vs. Batch Manufacturing, Paint and Coatings Industry, February 1999, Pages 100-103 Malhotra, Girish; ViewPoint: The Coating Industry’s Challenge for the New Millennium, Modern Paint & Coatings, October 1999, Page 60 Malhotra, Girish; Peixoto, Carlos A; Schotgues, Eduardo; Pfeil, Paulo R; The Color of Money: New technology helps improve coatings production efficiency and profitability, Modern Paint & Coatings, Feb. 2001, Page 22-24. Malhotra, Girish; Peixoto, Carlos A; Schotgues, Eduardo; Pfeil, Paulo R; In-line measurement and correction of Color and physical properties; 7th Nürnberg Coatings Conference, Nürnberg April 7-8, 2003 Malhotra, Girish; Peixoto, Carlos A; Schotgues, Eduardo; Pfeil, Paulo R; In-line measurement and correction of Color and physical properties; Symposium on Color and Appearance Instrumentation, April 15-16, 2003, Chicago, IL Malhotra, Girish; Process Puzzler: Maintaining Pump Prime: De-gas the ammonia; Chemical Processing, May 2004, pg 38 Malhotra, Girish; Process Puzzler: Take out Torque Slowly add fine powder: Chemical Processing, October 2004, pg 50 Malhotra, Girish; Peixoto, Carlos A; Schotgues, Eduardo; Pfeil, Paulo R; New Paradigm For Coating Manufacturing Processes; International Coatings Exposition October 25-29, 2004, Chicago, IL Malhotra, Girish: Coating manufacturing processes: Yesterday, today and tomorrow, Jan 5, 2005 http://www.specialchem4coatings.com Malhotra, Girish; Dispersion Equipment – an overview; March 2, 2005 http://www.specialchem4coatings.com Malhotra, Girish; Multicell Technology; Annual R&D Council and Operations Management Meeting for a major coating company; March 2005 Malhotra, Girish; Batch or a Continuous Process: A Choice; Pharmaceutical Processing, March 2005, Page 16 Malhotra, Girish; Process Puzzler: Stop Solvent losses; Chemical Processing, March 2005, Page 45 Malhotra, Girish; Process Puzzler; Choose a pump wisely: Chemical Processing Malhotra, Girish: VOC regulations and the Coatings Industry, May 2005 http://www.specialchem4coatings.com Malhotra, Girish; Process Puzzler: Know when the end is near; Chemical Processing, June 2005, Page 39 Chemical Week India Looks to Ethical Drugs, June 15, 2005, Page 27 http://www.chemweek.com/inc/articles/t/2005/06/15/029.html Malhotra, Girish, Less is More in API Process Development: Pharmaceutical Manufacturing, July/August 2005, Pages 50-51 Pharmaceutical Manufacturing Malhotra, Girish; Process Puzzler: Vanquish material variations; Chemical Processing, July 2005, Page 45 Malhotra, Girish; Process Puzzler: Remove the fatty oil first; Chemical Processing, August 2005, Page 54 Malhotra, Girish ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE, October 26, 2005 http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4187OPH2_01_Malhotra.ppt Malhotra, Girish; API Manufacture-Simplification and PAT; Pharmaceutical Processing, November 2005, Pages 24-27 Pharmaceutical Processing Malhotra, Girish; Process Puzzler: Prevent heat-exchanger plugging: Recycle concentrated solution; Chemical Processing, November 2005, Page 52 Malhotra, Girish; Simplification is Profitability: Pharmaceutical Technology, December 2005, Pages 14-16 Malhotra, Girish; Pharma’s Changing workforce, Pharmaceutical Manufacturing November/December 2005, Page 11 Malhotra, Girish: Making sense of temperature sensing: Poor Mixing? Chemical Processing January 2006 Malhotra, Girish: Indian Firms Tear Into Overseas API Markets, Chemical Week February 15, 2006, Pages 27- 36. Chemical Week Malhotra, Girish; Engineering, innovation, national well being. Chemical Engineering March 2006 Page 8 Malhotra, Girish: Fine Chemical Failures. Chemical Week, May 17, 2006, Page 5 Malhotra, Girish: Pharma Intermediates: M&A Frenzy Takes Hold, Chemical Week May 31, 2006, Page 33 Chemical Week Malhotra, Girish: Process Puzzler: Boost the reliability of a solvent supply pump- Use eccentric reducers; Chemical Processing, May 2006 Malhotra, Girish: Process Puzzler: Uncovering cause of solid build-up- Look at the material balance; Chemical Processing, September 2006 Malhotra, Girish: Indian Firm First to Gain FDA Approval for Pharma Formulation Intermediate, Chemical Week, September 20, 2006, Page 52 Malhotra, Girish; Process Puzzler: Automation – a boost to morale; Chemical Processing, November 2006, Page 50 Malhotra, Girish; QBD: First Things First, Pharmaceutical Manufacturing, November/ December 2006, Page 9 Pharmaceutical Manufacturing Malhotra, Girish; Process Puzzler: Sticky Valve-Focus on heat tracing failure; Chemical Processing, January 2007, Page 52 Chemical Week: Pharma Manufacturers Chase Greener, Cost-Efficient Chemistries, February 7, 2007, Page 21, Chemical Week Malhotra, Girish: QBD: Myth or Reality? Pharmaceutical Processing, February 2007, Pages 10-16 Malhotra, Girish: Process Puzzler: Quick fix needed! Eventually, do a redesign Chemical Processing, May 2007, Page 42 Malhotra, Girish: Can Pharma Learn From the Unfolding Gluten Contamination Story? Pharmaceutical Manufacturing May 3, 2007 Malhotra, Girish: Big Pharma and Lessons From Detroit’s Big Three: Focus on API Manufacturing, Or Lose Your Edge to Offshore Generics May 16, 2007 Pharmaceutical Manufacturing Malhotra, Girish: Continuous Processes Maintain Profitability, Drug Discovery and Development, June 2007, Pages 30-31 Malhotra, Girish: Big Pharma: Who's Your Role Model, Toyota or Edsel? Pharmaceutical Manufacturing June 2007, Page 40 Malhotra, Girish: Change is needed, GLG Group Analysis, July 16, 2007 Malhotra, Girish: Can Indian Pharmaceutical companies be a threat? GLG Analysis July 27, 2007 Malhotra, Girish: ICI a British Gem is sold GLG Group Analysis August 6, 2007 Malhotra, Girish: Concerns over Akzo buying ICI GLG Group Analysis August 20, 2007 Malhotra, Girish: Is IT a Catalyst for India’s Drug Industry Growth? Pharmaceutical Manufacturing, October 11, 2007 Chemical Week: Green Chemistry October 24, 2007 pg.23-26 Chemical Week Malhotra, Girish: Pharmaceuticals, Their Manufacturing Methods, Ecotoxicology, and Human Life Relationship, Pharmaceutical Processing, November 2007 Pg 18-23 Malhotra, Girish Personal Dose: A New Direction and Profit, Drug Discovery and Development, December 1, 2007 Chemical Week: Backlash in the Cards from Indian Plant Effluent Study? December 5, 2007 Page 31 Chemical Week Malhotra, Girish: Dow potential acquisition GLG Group Analysis December 17, 2007 Malhotra, Girish: New approach to develop drugs GLG Group Analysis December 20, 2007 Malhotra, Girish: Conversation of ABC, Dec. 2007 Published by EPCOT International Malhotra, Girish: Implementing QbD: A Step-by-Step Approach, Pharmaceutical Processing, February 2008 Pg 16-18 Malhotra, Girish: Is close good enough-Heparin Fiasco, GLG Group Analysis, March 5, 2008 Malhotra, Girish: Process Puzzler: Clarify a clogged caustic conundrum – Try Recirculation; Chemical Processing March 2008 pg 41-42 Malhotra, Girish: Process Puzzler: Succeed through thick and thin – Maintain the temperature; Chemical Processing April 2008 pg 45-47 Malhotra, Girish: Suzlon is having Teething Problem, GLG Group Analysis, April 22, 2008 Malhotra, Girish; Paint Cost can be reduced by manufacturing technology innovation, GLG Group Analysis April 23, 2008 Malhotra, Girish: Pharmaceutical Manufacturing: Is it the antithesis of Creative Destruction? Pharmaceutical Manufacturing, July 2008 Malhotra, Girish: Opportunities for Private Equity firms in India GLG Group Analysis, July 4, 2008 Malhotra, Girish: Opportunities for the Pharmaceuticals to improve their manufacturing technology, GLG Group Analysis, July 22, 2008 Malhotra, Girish: Pharmaceutical business strategy, GLG Group Analysis, August 7, 2008 Pharmaceutical Manufacturing: As Ranbaxy’s World Turns, So Does Generics Model July/August 2008 pg 12-14 Malhotra, Girish: Pharmaceutical companies and their effort to improve profits, GLG Group Analysis, September 11, 2008 Malhotra, Girish: Ranbaxy citations can be an opportunity, GLG Group Analysis, September 18, 2008 Malhotra, Girish: Pharma Convergence: Challenges in Drug Development and Manufacturing Methods, CHEManager Europe 10/2008, September 18, 2008, pg 26 Malhotra, Girish: API Manufacturing: A Road Map for Green Chemistry and Processes; pharmaQbD.com October 14, 2008 Malhotra, Girish: Is Pharma Consolidation on Horizon, GLG Group Analysis, October 28, 2008 Malhotra, Girish: Process Puzzler: Quell a quality control confrontation- Improve the Design; Chemical Processing November 2008 pg 40-42 Malhotra, Girish: APIs Simplicity by Design. A Low-tech Approach for Quality and Profitability, Mastering Process Chemistry, Philadelphia, November 17-19, 2008 Malhotra, Girish: Is "Creative Destruction" the way to go for the Pharmaceuticals? GLG Group Analysis, December 10, 2008 Malhotra, Girish: Process Puzzler: Get out of the Soup, Chemical Processing, December 2008 pg 28 Malhotra, Girish: Forget Bail Out or Hand Out - the Answer is Innovation and Conservation January 9, 2009 Chemical Week Malhotra, Girish: ISP: A Hidden ‘Diamond in the Rough’ January 13, 2009 Chemical Week Malhotra, Girish: Pfizer/Wyeth and GSK/UCB GLG Group Analysis January 26, 2009 Malhotra, Girish: Commoditization of Drugs February 4, 2009 Chemical Week Malhotra, Girish: Why Have the Fine and Specialty Chemical Sectors Been Moving from Developed Countries? February 9, 2009 Chemical Week Malhotra, Girish: Dow and ROH GLG Group Analysis February 9, 2009 Malhotra, Girish: Alphabet Shuffle: Moving From QbA to QbD - An Example of Continuous Processing, Pharmaceutical Processing, February 2009 pg 12-13 Malhotra, Girish: A Fine Chemical Version of Chernobyl? February 26, 2009 Chemical Week Malhotra, Girish: Pfizer, Generics and Commoditization GLG Group Analysis March 3, 2009 Malhotra, Girish: Rx for Pharma, Chemical Engineering Progress March 2009, Vol. 105, No. 3 Pg. 34-38 Malhotra, Girish: Global Fine/Specialty Chemical Industry and its Challenges, March 5, 2009, Profitability through Simplicity Malhotra, Girish: The Challenge for Fine and Specialty Chemical Firms, March 19, 2009 Chemical Week Malhotra, Girish: Pharmaceuticals and Return on Investment (ROI), March 26, 2009, Chemical Week Malhotra, Girish: The Nano: The New iPod of the Manufacturing Industry? March 27,2009 Chemical Week, Profitability through Simplicity Malhotra, Girish: Pharmaceuticals in Water, April 24, 2009 Profitability through Simplicity Malhotra, Girish: The Art of API Process Simplification and Scale-Up leading to QBD, Quality by Design Conference, International Pharmaceutical Academy, Toronto, April 27, 2009 Malhotra, Girish Process Puzzler: Kayo a Cascade Control Complication Chemical Processing May 2009 Pg. 43 Malhotra, Girish: Process of Continuous Improvement and Pharmaceuticals, June 1,2009 GLG Group Analysis Profitability through Simplicity Malhotra, Girish: What is Holding Back Quality by Design? June 15, 2009 Chemical Week, Profitability through Simplicity Malhotra, Girish: Recycling Coatings: An Environmental and Business Opportunity, July 8, 2009 Chemical Week, Profitability through Simplicity Malhotra, Girish: Hesitation In The Drive To A Continuous Pharmaceutical Manufacturing Process: Real or Imaginary? Pharmaceutical Processing, July 2009 pg-12-15 Malhotra, Girish: Climate Change and its Impact on Industrial Production, August 3, 2009 Chemical Week, GLG Group Analysis, Chemical Processing, Profitability through Simplicity Malhotra, Girish: Chemical Engineering: Understanding the Curriculum for Quality Manufacturing, August 5, 2009 Chemical Week, Chemical Processing, Profitability through Simplicity Malhotra, Girish: A Pharmaceutical Challenge for Technocrats, August 21, 2009, Chemical Week, Chemical Processing, Profitability through Simplicity Malhotra, Girish: Photographs, World Photographers Organization, Volume I, August 2009 pages 6, 13, 14, 15 Malhotra, Girish: Fine Chemicals: Quality Manufacturing and Technology Innovation in Pharmaceuticals, September 25, 2009, Chemical Week, Profitability through Simplicity Chemical Week, Cost Cutting Becomes the Pharma Industry's Mantra Chemical Week, October 5,2009 pg 24-28 Malhotra, Girish: Understanding QbD Requires Basic Fundamentals http://blog.pharmtech.com/ October 13, 2009 Malhotra, Girish: Photographs, World Photographers Organization, Volume 2, October 2009 page 9 Malhotra, Girish: QBA and Elements of QBD, Quality by Design, Challenges of implementing QbD I PAT in the development of rugged and robust formulations, processes, and Approvals October 19-20, 2009, Somerset, NJ Malhotra, Girish: Exploitation of QBA Elements for a Batch/ Continuous Process, Quality by Design, Challenges of implementing QbD / PAT in the development of rugged and robust formulations, processes, and Approvals October 19-20, 2009,Somerset, NJ Malhotra, Girish: An Interpretation of U.S. FDA Guidance for Pharma Manufacture, October 19, 2009 Chemical Week, Profitability through Simplicity Malhotra, Girish: Review of Continuous Process for Modafinil, Continuous Processing in the Chemical and Pharmaceutical Industry II, 2009 AIChE Annual Meeting, November 10, 2009,Nashville, TN. Malhotra, Girish: Analysis of API (Omeprazole): My perspective, Poster Session: Pharmaceutical Engineering, 2009 AIChE Annual Meeting, November 11,2009, Nashville, TN. Malhotra, Girish: What is Jugaad - a New Management Fad from India? December 10,2009 Chemical Week, Chemical Processing, Profitability through Simplicity World Images Today, World Photographers Organization, December 2009, pg 14,19-21 Malhotra, Girish: A Radical Approach to Fine/Specialty API Manufacturing Chemical Week, Profitability Through Simplicity January 20, 2010 Malhotra, Girish: Pharmexcil to invite drug regulators from Africa for brand buildup GLG Group Analysis January 28, 2010 Malhotra, Girish: HIV Drug Availability and Potential Manufacturing Opportunities, Chemical Week, Profitability Through Simplicity, February 2, 2010 Malhotra, Girish: World Images Today February 2010, pg 55 Malhotra, Girish: Pharmaceutical Costs, Technology Innovation, Opportunities and Reality, Pharmaceutical Processing February 2010 pgs 20-24 Green Chemistry: Lighting Up New Pharma Pathways, Chemical Week March 15,2010, pgs 21-23 Malhotra, Girish: Relationship between Big Pharmaceuticals and the Indian Pharmaceuticals, GLG Group Analysis March 15,2010 Malhotra, Girish: Alternate Interpretation of Pharmaceutical TLAs; Three letter Acronyms Chemical Week, Profitability through Simplicity, Pharmaceutical Processing, March 16,2010 Malhotra, Girish: Sanofi-Aventis Expansion in India, GLG Analysis, March 23, 2010 Malhotra, Girish: Process Centricity is the Key to Quality by Design, Pharmaceutical Processing, Chemical Week, Profitability through Simplicity April 6, 2010 Malhotra, Girish: Webinar: Simplifying Coating Formulations for Easier Scale-up Webinar, www.specialchem.com April 27, 2010 Malhotra, Girish: Microscopic Examination of Indian Pharmaceutical Acquisitions by Multinational Companies, Profitability through Simplicity, Chemical Week, GLG Analysis, May 25,2010 Malhotra, Girish: You're the CEO: Can You Justify the Costs of These QbD Projects? www.pharmaqbd.com June 4, 2010 Malhotra, Girish: Pharmaceutical Reverse Payments and Lower Drug Costs: An Interesting Dilemma, Profitability through Simplicity, Pharmaceutical Processing, Chemical Week, July 21, 2010 Malhotra, Girish: The Path Towards Continuous Processing, Pharmaceutical Processing, August 2010, pgs 16-20 Malhotra, Girish: Square Plug In A Round Hole: Does this Scenario Exist in Pharmaceutical? Profitability through Simplicity, Pharmaceutical Processing, Chemical Week, August 17,2010 Malhotra, Girish: The Importance of Fundamentals, Pharmaceutical Processing, Profitability through Simplicity, Chemical Week, August 31,2010 Malhotra, Girish: Are The Rules A Constraint to Innovation, Competition and A Cause of Adulterated Product? Profitability through Simplicity, Pharmaceutical Processing, Chemical Week, October 1, 2010 Chemical Week: Pharmaceuticals Counterfeiting Drives Change, Chemical Week, September 27/October 4, 2010 pgs 48-50 Malhotra, Girish: QbA--> QbD Imagination and Creativity Challenge, 5th International Conference and Exhibition, Process Analytical Technologies III Organic Process R&D, November 2, 2010, Clearwater, Florida Malhotra, Girish: Chemical Process Simplification: Improving Productivity and Sustainability, ISBN: 978-0-470-48754-9, Hardcover, 297 pages, February 2011, John Wiley & Sons Inc. Malhotra, Girish: Chapter “Simplified Process Development and Commercialization” in Quality by Design: From Theory to Practice co-published by Parental Drug Association and DHL Publishing© 2011 March 2011 available at www.pda.org/bookstore. Malhotra, Girish: Pharmaceutical Companies Can Innovate If they Want to, Profitability through Simplicity, Pharmaceutical Processing, Chemical Week, October 15, 2010 Malhotra, Girish: Comments on PAT Article, Chemical Engineering, pg 6, October 2010 Malhotra, Girish: Process Puzzler: Deal with a Decanter that Can't, Chemical Processing, November 2010 Malhotra, Girish: Constructive Destruction in Pharmaceutical Industry, GLG Group Analysis, December 13, 2010 Malhotra, Girish: Mr. Claus, Tear Down These Walls! PharmaQbD.com, December 16, 2010, Pharmaceutical Manufacturing Page 10, January 2011 Malhotra, Girish: Inefficiency in Fine Chemicals Manufacture Set to Grow, Chemical Week, February 1, 2011 Malhotra, Girish: Chapter “Simplified Process Development and Commercialization” in Quality by Design: From Theory to Practice co-published by Parental Drug Association and DHI Publishing© 2011 February 2011 available at www.pda.org Malhotra, Girish: Strategies to Enhance API Manufacturing: Identifying inefficiencies and optimizing development through quality by design, Business Insights, March 2011 Malhotra, Girish: QbA-> QbD: An imagination and creativity challenge, Chemica OGGI/ Chemistry TODAY March/April 2011, Vol. 29 n.2, pg 42-44. Malhotra, Girish: P&G and Teva is a win-win and Herculean Challenge for Many, GLG Group Analysis, March 26, 2011 Malhotra, Girish: Pharmaceutical Consolidation in the Developed Countries, GLG Group Analysis, March 31, 2011 Malhotra, Girish: Information Challenges for Product, Process Development and Process Design, Chemical Week, Profitability through Simplicity, Chemical Processing, Pharmaceutical Processing, April 11, 2011 Malhotra, Girish: Opportunities for the Indian Generic Pharmaceuticals, GLG Group Analysis, April 13, 2011 Malhotra, Girish: Pharmaceuticals start their drive to Consolidation, GLG Group Analysis, May 2, 2011 Malhotra, Girish: Who or What killed QbD? And is there hope for resuscitation? Pharmaceutical Processing, May 2011, pg 10-14 Malhotra, Girish: Drug Prices: Food vs. Medicine - A Difficult Choice for Some, Pharmaceutical Processing, Profitability Through Simplicity, Chemical Week, June 17, 2011 Malhotra, Girish: Sun Pharmaceuticals Industries could show Pharma's new course, July 5, 2011 Malhotra, Girish: Pharmaceutical Quality: Is it a Company or Regulatory Responsibility? August 1, 2011, Profitability Through Simplicity, Pharmaceutical Processing, Chemical Week Malhotra, Girish: Big Pharma's (Pfizer) First BIG Volley Against Generics, GLG Group Analysis, August 4, 2011 Malhotra, Girish: Generic Drug Fees: A Fantastic Opportunity, August 17, 2011, Profitability Through Simplicity, Pharmaceutical Processing, Chemical Week Malhotra, Girish: Drug Shortages: Causes and Cures, October 13, 2011 Profitability Through Simplicity, Pharmaceutical Processing, Chemical Week Malhotra, Girish: Does the Pharmaceutical Industry Need a Steve Jobs? November 9, 2011 Profitability through Simplicity, Pharmaceutical Processing, Chemical Week Malhotra, Girish: Drugs for Infectious Diseases, Funding and Opportunity, December 11, 2011, Profitability Through Simplicity, Chemical Week, Pharmaceutical Processing Malhotra, Girish, Manufacturing can address the global disease crisis, G+ December 19, 2011 Pharmaceuticals: Asian Contract Manufacturers Pose Challenge to Western Firms, Chemical Week, pgs 21-26, Feb6/13, 2012, Malhotra, Girish: Neglected Tropical Disease Drugs: What are they Telling US About Innovation? March 7, 2012 Profitability through Simplicity, Pharmaceutical Processing, Chemical Week Malhotra, Girish:Focus on Physical Properties To Improve Processes: Chemical Engineering, Vol. 119 No. 4 April 2012, pgs 63-66 Malhotra, Girish:Can the Combination of Creative Destruction and “Steve Jobs Traits” Lead to a Pharma QbD Spring? April 16, 2012, Profitability through Simplicity, Pharmaceutical Processing, Chemical Week Malhotra, Girish: A Guide to QbD for APIs, Pharmaceutical Processing, Volume 27, No. 4 May 2012, pg 46-49 Malhotra, Girish: Financial Justification for QbD and Cost of Regulation Compliance Profitability through Simplicity, Pharmaceutical Processing, Chemical Week, May 22, 2012 Malhotra, Girish: Is the New Terminology Going to Make the Pharmaceutical Processes Environmentally Friendly and Economic? Profitability through Simplicity, Pharmaceutical Processing, Chemical Week June 4, 2012 Malhotra, Girish: Is Continuous Processing in Pharma’s Future? Profitability through Simplicity, Pharmaceutical Processing, Chemical Week, July 24, 2012 Malhotra, Girish: Are the Savings of $120-$150 Billion Worth Having? Profitability through Simplicity, Pharmaceutical Processing, August 30, 2012 Malhotra, Girish: Patents: Should We Change Intellectual Property Model/Strategies? Profitability through Simplicity, Chemical Week, Pharmaceutical Processing, IPSTRATEGY.com October 5, 2012 Malhotra, Girish: Improving Global Affordability of HIV/AIDS Drugs Through Technology Innovation Profitability through Simplicity, Pharmaceutical Processing, Chemical Week October 19, 2012 Malhotra, Girish: Government of India’s Brand vs. Generics Tell of Today’s Conflicts and Reality Profitability through Simplicity, Pharmaceutical Processing November 15, 2012 Malhotra, Girish: Can Falsified Medicine and Other Directives Backfire? Profitability through Simplicity, Pharmaceutical Processing January 31, 2013 Malhotra, Girish: The Secret Life of APIs www.pharmaevolution.com February 26, 2013 Malhotra, Girish: The Secret Life of APIs: The Importance of Sociochemicology www.pharmaevolution.com April 4, 2013 Malhotra, Girish: Sociochemicalogy, www.pharmaevolution.com April 9, 2013 Malhotra, Girish: Lost in Translation? - Can QbD Translate to Jobs in the Pharmaceutical Industry? http://www.pharmpro.com April 17, 2013 Malhotra, Girish: Product Volume & API Process Optimization, www.pharmaevolution.com May 2, 2013 Malhotra, Girish: Improving APIs & Formulation: Are You Harnessing the Power of Liquids? http://www.pharmaevolution.com May 14, 2013 Chemical & Engineering News Volume 91 Issue 21 pp. 30-31 May 27, 2013 Malhotra, Girish: Is it Time to Revamp cGMPs? http://www.pharmaevolution.com May 29, 2013 Malhotra, Girish: QbD: Its Value, Impact and Economics, Pharma-QbD Forum, June 12-14, 2013, The LaLit, Mumbai India Malhotra, Girish: The Art of API Simplification and QbD based Manufacturing, Pharma-QbD Forum, June 12-14, 2013, The LaLit, Mumbai India Malhotra, Girish: QbD on the Menu at CPhI Mumbai: Industry Savings of $200 Billion Possible, June 19, www.pharmaevolution.com Malhotra, Girish: Can Clinton/Gates Save Pharma? www.pharmaevolution.com June 24, 2013 Malhotra, Girish: Letter to Indian Pharma CEOs: Have You Lost Your Chance to Innovate? www.pharmaevolution.com July 26, 2013 Malhotra, Girish: Increasing Profits by Reaching Pharma’s Silent Majority, http://www.pharmaevolution.com August 5, 2013 Malhotra, Girish: Shift to continuous process from batch and reap the benefits, Chemical Industry Digest, Vol. XXVI 8, August, 2013, pg. 7 Malhotra, Girish: Conflicts and opportunities in the Life of APIs, Chimica Oggi-Chemistry Today Vol. 31 (4) July/August 2013 pgs. 10-13 Malhotra, Girish: Imagine… a Process-Centered Pharma www.pharmaevolution.com September 11, 2013 Malhotra, Girish: Millions? Billions? A Matter of Perspective, www.pharmaevolution.com September 21, 2013 Malhotra, Girish: CPhI Pharma Evolution Annual Industry Report part 2, pgs 22-25 October 2013 Malhotra, Girish: The Nail That Sticks Out Could Change the World: When Culture Stifles Innovation, www.pharmaevolution.com November 14, 2013 Malhotra, Girish: Break the Rag Layer, Chemical Processing Process Puzzler, November 2013, Page 50 Malhotra, Girish: Indian Producers have to Consider a Process Centric Model, www.pharma.financialexpress.com page 58, 61, November 2013 Malhotra, Girish: Could the Google Books Decision Set a Precedent for Global Pharma Patents? http://www.pharmaevolution.com December 10, 2013 Malhotra, Girish: Revamp the Process, Chemical Processing, Process Puzzler, December 2013 Page 32 Malhotra, Girish: Can Emerging Pharma's Leadership Move On to the Next Stage? www.pharmaevolution.com December 18, 2013 Malhotra, Girish: Reading the Tea Leaves: Predictions for Pharma's Future, www.pharmaevolution.com January 15, 2014 Malhotra, Girish:Will Pharma's Global Customers Redefine Maslow’s Hierarchy of Needs? www.pharmaevolution.com January 27, 2014 Malhotra, Girish: What Do The Recent Ranbaxy Citations Teach Us? Profitability through Simplicity, February 4, 2014 Malhotra, Girish:Safety and Safe Practices in Chemical Manufacturing, March 17, 2014 Presented at Cleveland State University Senior Class Malhotra, Girish: Ranbaxy: Lessons and Opportunities, Contract Pharma, April 9, 2014, Contract Pharma, May, 2014 pg 28-29 Malhotra, Girish: Sun Pharma’s Exotic Challenge: How Real?, Profitability through Simplicity, April 23, 2014 Malhotra, Girish: API Manufacturing’s Stuck in the Mud. Pharmaceutical Manufacturing, May 2014 pg 42 Malhotra, Girish:Toward a Process-Centered Pharma, Contract Pharma, Vol.16, 5, Pg 46-48, June 2014 Malhotra, Girish: INJECT THE WAX AT THE PUMP, Chemical Processing, July 10, 2014 Malhotra, Girish: Why Fitting a Square Plug in a Round hole is Profitable for Pharma and Most Likely Will Stay? Profitability through Simplicity, Pharmaceutical Processing, August 1, 2014 Malhotra, Girish: Landscape Disrupters Are Becoming Part of the Pharma’s Playing Field, Profitability through Simplicity, August 17, 2014 Malhotra, Girish: Are Toyota’s manufacturing practices the right benchmark for the pharma? Chemica Oggi-Chemistry Today, Vol. 32(4), pg. 2-3,July/August 2014 Malhotra, Girish:A Blueprint for Improved Pharma Competitiveness, Contract Pharma, Vol. 16, 7, Pg. 46-49, September 2014 Malhotra, Girish: Is McLaren Going to be Pharma’s “Creative Destructionist”? Profitability through Simplicity, October 14, 2014 Malhotra, Girish: Regulatory Compliance vs. Operational Excellence: What Should Happen First? Profitability through Simplicity, February3, 2015 Malhotra, Girish: Compliance vs. Operational Excellence, Pharmaceutical Manufacturing, pg. 50, March 2015 Malhotra, Girish:Could Pharma’s New Movers and Shakers Make a Difference? Profitability through Simplicity, April 24, 2015 Malhotra, Girish:May Day May Day: Can Someone Help and Lower Drug Prices? Profitability through Simplicity, May 1, 2015 Malhotra, Girish:How to Justify Innovation and QbD in Manufacturing, Pharmaceutical Manufacturing, May 4, 2015 Pg. 35-36 Malhotra, Girish:Continuous Process in Pharmaceutical Manufacturing: Considerations, Nuances and Challenges, Contract Pharma, June 2, 2015 Malhotra, Girish: Can An Alliance Between US Pharmaceutical Benefit Managers (1) and Make in India (2) Lead to Lower Global Drug Prices?, Profitability through Simplicity, June 17, 2015 Malhotra, Girish: Are Software Technologies Going to be Pharma’s Creative Destructionists?, Profitability through Simplicity, July 14, 2015 Malhotra, Girish: Impact of 21CFR 314.70 on The Life of a Pharmaceutical Manufacturing Process, Profitability through Simplicity, August 7, 2015 Malhotra, Girish: Could Software Technologies be the “Creative Destructionist” for Pharmaceuticals and Chemicals?, Profitability through Simplicity, August 31, 2015 Malhotra, Girish: Manufacturing technologies and their part to achieve future pharmaceutical sales, Chemica Oggi Chemistry- Today, September/October 2015 Vol. 33(5) pg. 28-31 Malhotra, Girish: My perspective for Pharmaceutical Manufacturing Technologies/Processes and Continuous Improvements, CPhI October 2015,   Barcelona, Spain Malhotra, Girish: Is Pharma’s Goal to Serve Patients Per Billion or Million? Profitability through Simplicity October 2, 2015 Malhotra, Girish: Mitigate a Manager’s Mayhem: Go Back to Original Design, Chemical Processing, October 2015 Malhotra, Girish: Cleveland State University, Lecture to Two Senior Classes, Social Behavior of Chemicals, October 21, 2015 Malhotra, Girish: Calling for Change, Profitability through Simplicity, November 17, 2015 Malhotra, Girish: Is FDA Rule 21CFR314.70 a Case of “Shackled Freedom” for Pharmaceutical Manufacturing?, Profitability through Simplicity, Pharmaceutical Processing, November 19, 2015 Malhotra, Girish:Who Is/Or Should Be Driving Pharma’s Manufacturing Car: Regulators or the Regulated? Profitability through Simplicity, December 7, 2015 Malhotra, Girish: Pharma’s Landscape’s going to look a lot different in 2026 http://www.pharmvamanufacturing.com/articles/2016/pharma-landscape-2026/ February 5, 2016 Malhotra, Girish: Continuous Pharmaceutical Processes and Their Demands, Contract Pharma, pg 37-40, April 5, 2016 Malhotra, Girish: Can Senate And House Bills S2615 And HR 4784 [Increasing Competition in Pharmaceuticals Act] Alter the Pharmaceutical Landscape? Profitability through Simplicity, May 26, 2016 Malhotra, Girish: Pharmaceutical Process: Batch or Continuous Reality, Myth or Imagination, Contract Pharma: 2016 Contracting and Outsourcing Conference, New Brunswick, September 23, 2016 Malhotra, Girish: Manufacturing Processes Require Financial Justification, CPhI, September 26, 2016 pgs12-14 Malhotra, Girish: Manufacturing Processes Require Financial Justification, Contract Pharma, CPhI Annual Industry Report 2016: Expert Contribution, September 27, 2016 Malhotra, Girish: Financial Justification in Pharma, Pharmaceutical Manufacturing, Volume 15, Issue 9, November 4, 2016 Malhotra, Girish: Process Innovations: Who Should Lead & Their Impact? Contract Pharma, November 9, 2016 Vol. 18 No. 9, pg 69-71 Malhotra, Girish: Industry 4.0 (Digitization): Its Benefits to Pharma and Other Chemical Industries, Profitability through Simplicity, November 11, 2016 Malhotra, Girish: Opportunity to showcase excellence and drive forward industry standards: the CPhI Awards, Chemica Oggi-Chemistry Today, Vol. 34(6), November/December 2016, pgs 64-65 Malhotra, Girish: Develop A Dialog, Chemical Processing, December 2016, Vol. 78, Issue 12 Malhotra, Girish: Can Uniform Safety, Health and Effluent and Manufacturing Standards Create Process Technology Innovation and Competition in Pharmaceuticals? Profitability through Simplicity, January 10, 2017 Malhotra, Girish: Pharmaceutical Sales Forecasts: Fiction, Facts or Alternate Facts, Profitability through Simplicity, February 9, 2017 Malhotra, Girish: Manufacturing processes require financial justification, Chemica Oggi - Chemistry Today, Vol. 35 January/February 2017, pg. 38-39 Malhotra, Girish: Process Simplification and The Art of Exploiting Physical Properties, Profitability through Simplicity, March 10, 2017 Malhotra, Girish: Strategies for Improving Batch or Creating Continuous Active Pharmaceutical Ingredient (API) Manufacturing Processes, Profitability through Simplicity, March 20, 2017 Malhotra, Girish: Can the Review and Approval Process for ANDA at USFDA be Reduced from Ten Months to Three Months? Profitability through Simplicity, March 25, 2017 Malhotra, Girish: Reality and Un-Reality: Continuous Processing in Pharmaceutical Manufacturing, Contract Pharma, April 3, 2017 Malhotra, Girish: Would The Coating Industry's Consolidation Lead to Manufacturing Innovation? April 26, 2017 Malhotra, Girish: ANDA (Abbreviated New Drug Application) / NDA (New Drug Applications) Filing Simplification: Road Maps are a Must. Profitability through Simplicity, May 11, 2017 Malhotra, Girish: Kudos For Research, Chemical Processing, June 2017, Pg 47 Malhotra, Girish: The Medicine Maker Issue #0617, Calling for ANDA Action, June 2017 Malhotra, Girish: Batch, Continuous or "Fake/False" Continuous Processes, Profitability through Simplicity, July 20, 2017 Malhotra, Girish: An Alternate Look at the Pharmaceutical World Revenues and Drug Affordability, www.gmpnews.net, Autumn 2017, Pages 2-5 Malhotra, Girish: Innovation In Pharmaceuticals: What Would It Take & Who is Responsible? Profitability through Simplicity, November 28, 2017 Malhotra, Girish: Pharmaceutical Manufacturing Technology Innovation: Does Reading the Tea Leaves Matter? Profitability through Simplicity, December 22, 2017 Malhotra, Girish: Forget About and Easy Fix, An Essential Question, Chemical Processing, December 2017, Pg 32 Malhotra, Girish: Comparison of Drugs Prices: US vs. India; Their Manufacturing Costs & Opportunities to Improve Affordability, Profitability through Simplicity, January 18, 2018 Malhotra, Girish: Could Amazon (A), Berkshire Hathaway (B) and J.P. Morgan Chase (M) be the Anti Ballistic Missile (ABM) needed to Control/Curb Rising Healthcare Costs? Profitability through Simplicity, February 9, 2018: Healthcare Costs Run Rampant, Contract Pharma, March 2018, Vol. 20, No. 2 Pg 32-34 Girish Malhotra: Opportunities to Lower Drug Prices and Improve Affordability: From Creation (Manufacturing) to Consumption (Patient), Profitability through Simplicity, March 9, 2018, Contract Pharma, May 8, 2018, gmpnews.net, Pgs.44-47, No. 1(2) 2018 Malhotra, Girish: The Good, The Bad, and The Ugly1 Complexities of the Pharmaceutical Manufacturing, Profitability through Simplicity, April 9, 2018, Contract Pharma June 2018 Vol. 20 No.5 Video: Continuous Pharmaceutical Manufacturing: American Pharmaceutical Review, April 17, 2018 Continuous Processing Roundtable, American Pharmaceutical Review, pgs. 54-58, April 2018 Malhotra, Girish: Learn Some Lessons, Chemical Processing, April, 2018 pg. 22 Malhotra, Girish: Improving Drug Affordability for the United States Populous through Alternate Business Models, Profitability through Simplicity, May 4, 2018; American Pharmaceutical Review, Vol 21 Issue 4, Pg. 12-14 Malhotra, Girish: Amazon PillPack Marriage can Alleviate Drug Shortages and May be Lower Drug Prices, Profitability through Simplicity, July 5, 2018 Malhotra, Girish: Pharma's future is putting innovations in the hands of innovators, CPhI Annual Industry Report 2018, August 23, 2018, Contract Pharma, September 11, 2018 pgs. 30-34 Malhotra, Girish: Past, Present and Future in Pharmaceuticals, Profitability through Simplicity, October 5, 2018 Malhotra, Girish: A 20 Year Retrospective: The Pharmaceutical Industry Then and Now, American Pharmaceutical Review, October 15, 2018 Malhotra, Girish: Keeping Innovation in our Hands, Pharmaceutical Manufacturing, Pg. 42, October 2018 Malhotra, Girish: What Is Needed for a Regulatory Approval of NDA/ANDA Filings in 90 Days? Profitability through Simplicity, October 24, 2018 Malhotra, Girish: Quick Review of Chemicals Related Process Development, Design and Scale up Considerations, Profitability through Simplicity, November 7, 2018 Malhotra, Girish: Take a Cold-Eyed Look at a Cooling Problem, Chemical Processing, November 2018 pgs. 43 Malhotra, Girish: Simplified Roadmap for ANDA/NDA Submission and Approval will change Pharma Landscape, Profitability through Simplicity, November 25, 2018 Malhotra, Girish: Identifying the Root Causes of Drug Shortages and Finding An Enduring Solution, Profitability through Simplicity, December 7, 2018, Pharmaceutical Processing, December 10, 2018 Malhotra, Girish: Weigh The Cause Of Feeder Problems, Chemical Processing, pg.32, December, 2018 Malhotra, Girish: Set Up An Internal Team, Process Puzzler, Chemical Processing, February 2019 Malhotra, Girish: Impact of Regulations, Drug Manufacturing and Pharma Supply Chain (PBMs and allies) in Drug Shortages and Affordability, Profitability through Simplicity, March 8, 2019 Malhotra, Girish: Impact of Regulations, Manufacturing and Pharmaceutical Supply Chain (PBMs) on Drug Shortages and Affordability: Part 2: Profitability through Simplicity, April 3, 2019 Malhotra, Girish: Delve Deeper, Chemical Processing, April 9, 2019 Malhotra, Girish: Considerations to Simplify Organic Molecule (API) Manufacturing Processes: My perspective, Profitability through Simplicity, April 20, 2019 Malhotra, Girish: Opportunities for Generic Pharma to Clear the Quality Stigma, Profitability through Simplicity, May 23, 2019 Malhotra, Girish: Systematic Demystification of Drug Price Mystique and the Needed Creative Destruction, Profitability through Simplicity, October 2, 2019 Generics drive API growth, Chemical Week, September 23/30 2019, pgs. 32-34 Malhotra, Girish: Are USFDA 483 Citations a "Medal of Honor" or "Rite of Passage" to Disgrace for the Pharma companies? Profitability through Simplicity, October 16, 2019 Malhotra, Girish: Pharmaceutical Quality: Concepts, Misconceptions, Realities and Remedies, Profitability through Simplicity, CPhI Annual Report 2019, November 4, 2019 Malhotra, Girish: Drug Shortages, Quality and Prices: Who is Responsible? Profitability through Simplicity, November 6, 2019