News about Quality / GMP

US FDA places Glenmark Pharma's Baddi facility under import alert

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

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

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

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

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

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

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

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 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

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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