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India’s Shilpa Medicare has received a warning letter from the US FDA for its finished dosage formulation facility in Jadcherla, Telangana. The company has insisted that supplies from the facility will not be disrupted while it engages with the FDA to resolve the issues.
High ratings on factors like quality culture could yield post-approval change flexibility for participating drug product and API manufacturing facilities.
After making several targeted investments aimed at enhancing its global production network, Siegfried has announced the acquisition of two manufacturing sites from Novartis in Spain. With this acquisition, the Swiss contract development and manufacturing organization is looking to create opportunities for profitable growth and achieve “critical size.”
European procurement models that focus solely on the lowest-cost generics are jeopardizing efforts to strengthen the supply chain and secure investments in local manufacturing, says Christoph Stoller, president of Medicines for Europe.
After receiving a response from Panacea Biotec in March 2020 over Form 483 observations stemming from a February inspection, the FDA has gone ahead and issued a warning letter to the company relating to its manufacturing facility based in Himachal Pradesh, India, citing two key cGMP violations.
California’s recently approved Generic Drug Pricing Bill gives its Health and Human Services Agency the authority to enter contracts with drug manufacturers with the main aim of increasing competition, lowering prices and addressing shortages in the market for generic prescription drugs.
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