News about Quality / GMP

Zydus Lifesciences bags US FDA approval for Sildenafil for Oral Suspension

The drug will be manufactured at the group’s formulation manufacturing facility at Baddi, Himachal Pradesh

Quality / GMP | 03/10/2022 | By Sudeep Soparkar |  510

Lupin gets EIR from US FDA for its Ankleshwar facility

The inspection of the facility was conducted from August 16-19, 2022

Quality / GMP | 03/10/2022 | By Sudeep Soparkar |  1051

Zydus Lifesciences' Ahmedabad unit under USFDA observation

The inspection was conducted between September 23 to September 29, 2022

Quality / GMP | 30/09/2022 | By Sudeep Soparkar |  1137

Lupin's Tarapur facility receives warning letter from US FDA

The company believes that the warning letter will not affect supply disruptions or current revenues from this facility's operations

Quality / GMP | 29/09/2022 | By Sudeep Soparkar |  811

Torrent Pharma's Gujarat facility gets three observations from US FDA

The inspection was carried its manufacturing facility at Indrad, Gujarat from September 19, 2022, to September 28, 2022
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Quality / GMP | 29/09/2022 | By Sudeep Soparkar |  561

Shilpa Medicare's plant in Telangana bags US FDA clearance

The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited (Parent Organization) and its agreed parties

Quality / GMP | 23/09/2022 | By Sudeep Soparkar |  1253

China API plant banned by FDA for having no quality control in place

The batch testing that was performed was done over and over again, and only some of the results were recorded
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Quality / GMP | 11/08/2022 | By Sudeep Soparkar |  664

Strides Pharma successfully completes US FDA inspection at Singapore facility

The inspection was completed successfully with Zero 483 observations

Quality / GMP | 11/08/2022 | By Sudeep Soparkar |  1209

Smoke study during material transfer

We have to prove that laminar airflow is maintained in the filling machine while doing various activities in the filling machine. Let's find out what are these activities.

Quality / GMP | 10/05/2022 | By Sudeep Soparkar |  1204

Zydus under three observations from FDA

Indian-based pharma company Zydus Lifesciences just got hit with a triple whammy by the U.S. FDA.

Quality / GMP | 26/04/2022 | By Sudeep Soparkar |  735