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Latest From Penelope MacRae
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.
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.
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.
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.
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.
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.