US FDA places Glenmark Pharma's Baddi facility under import alert
The company will engage with the agency to resolve the import alert at the earliest
Quality / GMP | 27/01/2023 | By Sudeep Soparkar
Solara Active Pharma Sciences' Cuddalore facility completes WHO PQ inspection
The Cuddalore API site is a multi-product facility
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Quality / GMP | 27/01/2023 | By Sudeep Soparkar
Torrent Pharma gets US FDA warning letter for Gujarat facility
The company said that this inspection classification will not have an impact on existing supplies or revenues from this facility
Quality / GMP | 25/01/2023 | By Sudeep Soparkar
US FDA inspects Indoco Remedies' solid oral formulation facility in Goa
The inspection was conducted from January 16 to 20, 2023
Quality / GMP | 24/01/2023 | By Sudeep Soparkar
Strides Pharma completes WHO PQ inspection at Puducherry facility
The inspection was carried out between January 16-20, 2023
Quality / GMP | 23/01/2023 | By Sudeep Soparkar
Stelis Biopharma's facility receives EIR from US FDA
The company received the EIR from USFDA for the drug-device combination to be commercialised from the company's flagship facility in Bengaluru<br />
Quality / GMP | 20/01/2023 | By Sudeep Soparkar
Switzerland, US in agreement on pharma GMP
Under the agreement, both countries will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections
Quality / GMP | 19/01/2023 | By Sudeep Soparkar
Strides Pharma's Bengaluru facility receives EIR from US FDA
The abbreviated Quality System Inspection Technique (QSIT) drug pre-approval on-site inspection was specifically conducted by the US FDA
Quality / GMP | 18/01/2023 | By Sudeep Soparkar
Celadon Pharma's UK-based facility bags GMP registration by MHRA
Celadon's medicinal cannabis product will be supplied in oil form as an API
Quality / GMP | 17/01/2023 | By Sudeep Soparkar
Lupin gets two observations from US FDA for Somerset facility
The inspection closed with the issuance of a Form-483 with two observations
Quality / GMP | 17/01/2023 | By Sudeep Soparkar
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