News about Quality / GMP

US FDA issues fresh observations for Aurobindo Pharma's Sangareddy facility

According to the USFDA site, the company's unit 11 has already been classified as "voluntary action indicated," which means objectionable practises were found at the manufacturing unit

Quality / GMP | 21/11/2022 | By Sudeep Soparkar |  818

Strides Pharma bags US FDA approval for potassium chloride oral solution

The products will be manufactured at the company’s facility in Bengaluru

Quality / GMP | 18/11/2022 | By Sudeep Soparkar |  471

Aurobindo Pharma receives EIR from US FDA for AP facility

The company's Unit XI at Pydibhimavaram is an API non-antibiotic manufacturing facility

Quality / GMP | 17/11/2022 | By Sudeep Soparkar |  1537

Piramal Pharma gets zero observations from US FDA for Riverview, Michigan facility

The inspection was completed successfully with Zero Form - 483 observations

Quality / GMP | 11/11/2022 | By Sudeep Soparkar |  1209

Sun Pharma receives US FDA communication as OAI

The communication states that the US FDA may withhold approval of any pending product applications or supplements filed from this facility<br />

Quality / GMP | 09/11/2022 | By Sudeep Soparkar |  821

Zydus Lifesciences receives EIR from US FDA for Moraiya facility

The US FDA had inspected the facility from July 26 to August 5, 2022<br />

Quality / GMP | 07/11/2022 | By Sudeep Soparkar |  949

Solara Active Pharma gets EDQM CEP nod for Ibuprofen for Vizag facility

With this key approval, Solara has CEP approval for two manufacturing facilities for Ibuprofen API, the other being its dedicated manufacturing facility located at Puducherry

Quality / GMP | 07/11/2022 | By Sudeep Soparkar |  1038

Alembic Pharma bags US FDA approval for Ketorolac Tromethamine injection

This is the second injectable product approved by the company's General Sterile Facility (F-3) which was inspected in August 2022

Quality / GMP | 04/11/2022 | By Sudeep Soparkar |  812

Glenmark Pharma receives ANDA approval for Sodium Phenylbutyrate Tablets USP, 500 mg

Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the US by Glenmark Pharmaceuticals, USA

Quality / GMP | 03/11/2022 | By Sudeep Soparkar |  691

Lupin receives US FDA's five observations

The inspection was conducted from October 17, 2022, to October 29, 2022

Quality / GMP | 31/10/2022 | By Sudeep Soparkar |  609