News about Quality / GMP

eXmoor pharma Expands into Full-Service Cell and Gene Therapy CDMO Partner with Opening of GMP Facilities

eXmoor pharma Expands into Full-Service Cell and Gene Therapy CDMO Partner with Opening of GMP Facilities

The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.

Quality / GMP | 18/10/2023 | By Manvi 187

Gritgen Therapeutics Launches Operations at Commercial GMP Facility in China

Gritgen Therapeutics Launches Operations at Commercial GMP Facility in China

The facility adheres to the global cGMP standards and complies with the regulatory guidelines of authoritative agencies including the NMPA, the FDA and the EMA.

Quality / GMP | 16/10/2023 | By Manvi 143

Aurisco's Manufacturing Site in China Clears FDA Inspection

Aurisco's Manufacturing Site in China Clears FDA Inspection

Aurisco's Manufacturing Site in China Clears FDA Inspection

Quality / GMP | 24/08/2023 | By Sudeep Soparkar 157

Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets (OTC)

Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets (OTC)

Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets (OTC)

Quality / GMP | 23/08/2023 | By Sudeep Soparkar 150

Concord Biotech Limited receives EIR for Unit III

Concord Biotech Limited receives EIR for Unit III

Concord Biotech Limited receives EIR for Unit III

Quality / GMP | 23/08/2023 | By Sudeep Soparkar 169

Successful FDA inspection at Auriscos manufacturing site in Yangzhou, China

Successful FDA inspection at Auriscos manufacturing site in Yangzhou, China

Successful FDA inspection at Aurisco's manufacturing site in Yangzhou, China

Quality / GMP | 16/08/2023 | By Sudeep Soparkar 240

Lupins Mandideep Unit-2 Facility Completes U.S. FDA Inspection with No Observations

Lupins Mandideep Unit-2 Facility Completes U.S. FDA Inspection with No Observations

Lupin’s Mandideep Unit-2 Facility Completes U.S. FDA Inspection with No Observations

Quality / GMP | 14/08/2023 | By Sudeep Soparkar 175

Dr. Reddys API plant in Hyderabad gets EIR from U.S. FDA

Dr. Reddys API plant in Hyderabad gets EIR from U.S. FDA

Dr. Reddy’s API plant in Hyderabad gets EIR from U.S. FDA

Quality / GMP | 08/08/2023 | By Sudeep Soparkar 381

Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis

Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis

Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis

Quality / GMP | 08/08/2023 | By Sudeep Soparkar 250

USFDA concludes inspection at Solara's Cuddalore facility with Zero 483 inspectional observations

USFDA concludes inspection at Solara's Cuddalore facility with Zero 483 inspectional observations

USFDA concludes inspection at Solara's Cuddalore facility with Zero 483 inspectional observations

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

 
 

 

 

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