Shilpa Pharma Lifesciences’ Unit II, Raichur, Karnataka clears PMDA Japan, GMP inspection

The inspection has concluded successfully on 1st September 2023 without any critical/major observation

NIH and Exothera partner to produce GMP intranasal vaccine against SARS-CoV-2 for clinical phase I/II trial in Africa and US

NIH’s candidate is based on the Adenovirus 4 backbone, largely used as a vector candidate in HIV and influenza vaccine clinical trials

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