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

USFDA inspection update on Jubilant HollisterStier’s Montreal facility

HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures

Fermenta Biotech receives EU GMP Certification for its Dahej facility

This approval reflects company’s unwavering commitment that the quality assurance

Laurus Labs inaugurates Rs. 250 crore R&D facility in Telangana

Total investment incurred for setting up the new R&D Rs 250 crore

USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations

The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices