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A Council amendment granting Member States the authority to insist that marketing authorisation holders supply approved medicines in sufficient quantities to cover the needs of patients in the relevant jurisdiction, via a new article in the pharmaceutical directive, will not be well received by industry

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To view or add a comment, sign in Biocon Pharma, a wholly owned subsidiary of Biocon Ltd., in partnership with Carnegie Pharmaceuticals, has received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg

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