Hikal receives Brazilian GMP certification and USFDA EIR for Bangalore and Panoli facilities

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories

Meissa Vaccines enters into CGMP manufacturing agreement for pediatric RSV vaccine candidate for Phase 2 clinical trials

Exothera will manufacture Meissa’s MV-012-968 vaccine candidate under CGMP regulations to supply Phase 2 clinical trials

Indoco's Baddi facility receives EUGMP certification from Health Authority of Germany

The EU certification will support supplies of drug products registered in Europe, from this manufacturing site

Venus Remedies receives Ukrainian GMP approval for Its Carbapenem, Oncology parenteral facilities

The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations

Venus Remedies gets Kenyan GMP certification for its manufacturing facilities in Baddi

The approval paves the way for consolidating the company’s position in Kenya and other African markets as part of its global expansion plans

Shilpa Medicare Analytical Services Division gets VAI status from USFDA after GMP inspection

This is the second US FDA GMP inspection of this facility within one year

Biocon Biologics' new mAbs facility receives EU GMP Certification for bBevacizumab

This approval reflects Biocon Biologics' compliance with the highest international regulatory standards

Par Drugs and Chemicals receives WHO-GMP certificate

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

Venus Remedies awarded Saudi GMP approval for all its production facilities in Baddi

The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region