News about Quality / GMP

USFDA completes inspection at Dr Reddy's Laboratories Ltd's Bollaram API unit

USFDA completes inspection at Dr Reddy's Laboratories Ltd's Bollaram API unit

Quality / GMP | 19/06/2023 | By Sudeep Soparkar |  908

Natco Pharma receives EIR from USFDA for Vizag facility

Natco Pharma receives EIR from USFDA for Vizag facility

Quality / GMP | 16/06/2023 | By Sudeep Soparkar |  1149

FDC Ltd receives EIR from USFDA for Manufacturing Facility at Waluj

FDC Ltd receives EIR from USFDA for Manufacturing Facility at Waluj

Quality / GMP | 16/06/2023 | By Sudeep Soparkar |  883

Bliss GVS Pharma Ltd updates on inspection by USFDA

Bliss GVS Pharma Ltd updates on inspection by USFDA

Quality / GMP | 16/06/2023 | By Sudeep Soparkar |  667

Granules India Ltd received ANDA Approval for Metoprolol Succinate ER Tablets

Granules India Limited today, announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended-Release Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg.

Quality / GMP | 14/06/2023 | By Sudeep Soparkar |  548

Ipca Laboratories Ltd gets Form 483 with 11 observations for API manufacturing facility at Ratlam

Ipca Laboratories Limited has announced that the US FDA conducted the inspection of the Company's APIs manufacturing facility situated at Ratlam, Madhya Pradesh from 5th June, 2023 to 13th June, 2023. At the conclusion of the inspection, the US FDA issued a Form 483 with 11 (eleven) observations.<br />

Quality / GMP | 14/06/2023 | By Sudeep Soparkar |  1318

Hyderabad-based Bharat Biotech recalls typhoid vaccine batch owing to substandard quality

Hyderabad-based Bharat Biotech recalls typhoid vaccine batch owing to substandard quality

Quality / GMP | 09/06/2023 | By Sudeep Soparkar |  668

Zydus receives final approval from the USFDA for Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg

Zydus receives final approval from the USFDA for Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg

Quality / GMP | 09/06/2023 | By Sudeep Soparkar |  314

Zydus receives final approval from the USFDA for Tadalafil Tablets USP, 20 mg

Zydus receives final approval from the USFDA for Tadalafil Tablets USP, 20 mg

Quality / GMP | 09/06/2023 | By Sudeep Soparkar |  468

GEODIS Strengthens Pharma Capabilities in the Americas With Seven IATA CEIV Pharma Certifications

GEODIS, a world leader in transport and logistics, announced today it has strengthened its air freight temperature-controlled pharma shipment capabilities across the Americas region by earning IATA's Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma) certification across seven sites in the United States.

Quality / GMP | 08/06/2023 | By Sudeep Soparkar |  432