Remove Contamination Remove FDA Approval Remove Generic Drugs
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Indian pharma manufacturing: rising investment in Andhra Pradesh

Pharmaceutical Technology

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Most sites in Andhra Pradesh and Telangana had FDA and/or EMA approval (297 out of a total 476 sites). ©GlobalData.

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Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. For new or generic drugs to work in a patient, they must, of course, be made correctly by using Current Good Manufacturing Practices. drug supply.

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Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” For an excellent overview of the EU’s regulatory system, see: Excellent overview of the European Union’s drug regulatory system.

Drugs 71
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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).