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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. Pharma manufacturing facilities in Andhra Pradesh and Telangana accounted for 22.5% © GlobalData. © GlobalData.

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STAT+: Major Indian generic drugmaker closes a U.S. facility after years of manufacturing problems

STAT News

After a decade of manufacturing problems, a U.S. federal court ordered a unit of Wockhardt, one of the largest makers of generic drugs, to refrain from making allegedly adulterated medicines at a facility in Illinois. However, the U.S. Continue to STAT+ to read the full story…

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

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Pharma Microbiology East Coast Conference – A Virtual Conference with Remote Access

pharmaphorum

The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. in Biology and Ph.D.

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Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

Terms and conditions would be imposed after discussions with the manufacturer and would obligate them to take steps to manage risks and resolve uncertainties. An RMP summarizes the risks of a drug and the pharmacovigilance activities and other measures that a manufacturer puts in place to monitor and manage any identified risks.

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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. The FDA is also looked to by drug regulatory authorities in other countries for its strengths. The FDA’s Role in Protecting Our Drug Supply. Far from it.

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Jailed pharma exec fined £47m and banned from industry

pharmaphorum

The company was slammed for restricting distribution of its drug so generic drug manufacturers couldn’t conduct bioequivalence tests or access a key ingredient used in the drug’s production. Many people carry the illness but do not exhibit symptoms.