Granules India update on USFDA inspection at Gagillapur facility

Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA

Lonza announces first GMP batch completion at next-generation mammalian manufacturing facility in US

First GMP batch released at Lonza’s next-generation mammalian manufacturing facility in Portsmouth (US)

Lubrizol and Polyhose ink MoU to set up medical tube manufacturing facility in Tamil Nadu

This agreement reinforces Lubrizol’s commitment to Make-In-India and broadens a previously committed US$ 350 million investment to support local manufacturing

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

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

Granules India’s Unit V facility secures USFDA EIR with NAI status

The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit

Venus Remedies gets approval from Malaysian PIC/S GMP for pre-filled syringe facility

The recognition from Malaysia's NPRA, a member of PIC/S, opens doors to new global business opportunities

Biocon Biologics refinances US$ 1.1 billion debt through USD bonds, new syndicated facility

US$ 800 million senior secured notes, the largest high yield debut USD bond issuance from India in the last 10 years

Zydus receives EIR for the transdermal manufacturing facility

This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated

Piramal Pharma Solutions announces US$ 80 million expansion plan for Sterile Injectables facility in Kentucky

USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

The inspection concluded with the issuance of a form 483 with five observations