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Penelope MacRae

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Latest From Penelope MacRae

FDA Warning Letter Blasts Glenmark

Glenmark, which has been the recipient of a string of notices from the US Food and Drug Administration over manufacturing quality issues, is again under fire with the regulator blasting the leading Indian drugmaker for failing to ensure “consistent production” of safe and effective products.

Manufacturing Compliance

Centrient Slaps Dalas With Second Amoxicillin Lawsuit

Netherlands-based Centrient Pharmaceuticals, a global leader in producing “sustainable” enzymatic antibiotics, next-generation statins and antifungals, has filed a second lawsuit against Indian company Dalas Biotech accusing it of patent infringement.

Intellectual Property India

Krka Vastly Expands Research Capacity

Slovenia’s Krka has inaugurated a €55.6m research and development centre that nearly doubles its R&D capabilities and will help drive new product launches.

Strategy Research & Development

Morepen Adds ‘Blockbusters’ To API Portfolio

India’s Morepen Laboratories has added two “blockbuster drugs” and one niche product to its API portfolio for sale in its domestic and global markets as it looks to move up the value chain following approval for its in-house R&D center.

Strategy Ingredients

Hilleman’s Shigella Vaccine Moves To Trials In Europe, Africa In ‘Big Step Forward’

India’s Hilleman Laboratories’ pioneering vaccine to treat shigellosis, a form of dysentery that’s a leading killer of young children, is moving into clinical trials in Europe and Africa, but expected launch date has been pushed back in parallel.

 

Research & Development Clinical Trials

AAM Slams California Pay-For-Delay Ban

US off-patent industry association the AAM has blasted as unconstitutional a groundbreaking California law banning so-called ‘pay-for-delay’ deals under which brand companies pay rivals to keep generics off the market.

Regulation Legislation
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