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Results For "GMP-certificate"

19 News Found

Shilpa Medicare’s Unit VII, Nacharam, Hyderabad receives GMP certificate from EMA, Austria
News | December 22, 2024

Shilpa Medicare’s Unit VII, Nacharam, Hyderabad receives GMP certificate from EMA, Austria

The company has received the GMP Certification after successful closure of the inspection


EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility
Drug Approval | November 13, 2024

EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility

The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections


Natac receives GMP certificate to manufacture for the pharmaceutical sector
News | October 12, 2024

Natac receives GMP certificate to manufacture for the pharmaceutical sector

The GMP certificate will allow the manufacturing site in Hervás, Cáceres to manufacture active ingredients for the pharmaceutical industry that is based on medicinal plants


Concord Biotech receives GMP certificate from Kenya regulator
Drug Approval | February 26, 2024

Concord Biotech receives GMP certificate from Kenya regulator

The said Unit complies with the prescribed Good Manufacturing practices as per relevant WHO technical Report Series


Par Drugs and Chemicals receives WHO-GMP certificate
News | March 06, 2023

Par Drugs and Chemicals receives WHO-GMP certificate

The audit was commenced for newly renovated manufacturing Block 1, Block 2, and Block 3


Orchid Pharma's Alathur API facility successfully completes USFDA inspection
Drug Approval | February 20, 2025

Orchid Pharma's Alathur API facility successfully completes USFDA inspection

The Alathur facility specializes in the production of Cephalosporin antibiotics


CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA
News | February 03, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia


CuraTeQ Biologics receives positive opinion for biosimilar Zefylti
Drug Approval | December 14, 2024

CuraTeQ Biologics receives positive opinion for biosimilar Zefylti

Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells


Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Drug Approval | July 30, 2024

Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance


Briefs: Concord Biotech and Shelter Pharma
News | June 08, 2024

Briefs: Concord Biotech and Shelter Pharma

Shelter Pharma Limited secured an order from Berlin International Medical Co D3Cure 50 ml x 30000 pcs