News about Quality / GMP

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 |  991

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 |  838

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 |  617

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 |  717

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 |  724

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 |  550

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 |  547

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 |  514

Jubilant Generics Roorkee facility receives USFDA's communication on classification report

As per the filing, the company currently supplies one product to the US market that contributes low single-digit revenue to Jubilant Pharmova revenues

Quality / GMP | 31/10/2022 | By Sudeep Soparkar |  1173

US FDA conducts pre approval inspection at Laurus Labs' facility

The inspection was conducted at Visakhapatnam facility

Quality / GMP | 31/10/2022 | By Sudeep Soparkar |  1136