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

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

Kwality Pharma received approval for Leuprorelin Acetate for injectable suspension from Greece

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

MilliporeSigma invests US$ 76 million to expand ADC manufacturing in North America

Reinforces position as first commercially approved contract development and manufacturing organization (CDMO) for ADCs in North America

AGC Biologics begins operations at new manufacturing building in Copenhagen

The new facility uses the latest mammalian systems and single-use technology, including a production line with eight 2,000 L bioreactors

USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

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

Akums appoints Shantanu R Chobhe as Corporate Quality Assurance Head

Chobhe brings over 30 years of extensive experience in quality and regulatory management within the pharmaceutical industry

Aptar’s nasal unidose system delivers FDA-approved neffy

This marks the first regulatory approval worldwide for nasally-delivered epinephrine

USFDA completes inspection at Biocon Biologics’ facilities in Bengaluru

The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants

Urgent need to redefine pharma companies’ role on several issues of the industry: Dr. K. Nagaiah, Chief Scientist, CSIR - IICT, Hyderabad

The expiry date of almost all strips is rubber stamped vanish in a matter of 3 to 4 months, making the remaining tablets waste for subsequent use before expire date