News about Quality / GMP

Gufic receives approval from NMPA, China for Prilocaine API

Gufic receives approval from NMPA, China for Prilocaine API

Quality / GMP | 19/06/2023 | By Sudeep Soparkar |  751

NATCO receives final approval for Tipiracil Hydrochloride and Trifluridine for the US market

NATCO receives final approval for Tipiracil Hydrochloride and Trifluridine for the US market

Quality / GMP | 19/06/2023 | By Sudeep Soparkar |  1147

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 |  1284

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 |  1693

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 |  1357

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 |  1182

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 |  678

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 |  1985

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 |  961

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 |  499