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Patents, Publications, Presentations and Quotations [Printable Version] 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: A Modest Proposal for High Drug Costs: Let Them Drink Tap Water, March 18, 2008 http://community.pharmamanufacturing.com/ 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: How Do We Justify Investments in QbD, August 26, 2010, www.pharmaqbd.com 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: Are the Savings of $120-$150 Billion Worth Having? Profitability through Simplicity, Pharmaceutical Processing, Chemical Week, August 30, 2012