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

Biocon Biologics insulins facility in Malaysia receives EU GMP Certification

The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.

Biocon Sdn. Bhd. enters Malaysia Book of Records

The 562,000 square feet facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by MBR

Malaysia awards three-year contract for Biocon Biologics’ Insugen

Biocon Biologics’ Insugen formulations will be available to patients at all Ministry of Health hospitals, district health offices and health clinics

U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations

The company does not expect the outcome of this inspection to impact its plans

LENZ Therapeutics, Lotus Pharmaceutical submit NDA for presbyopia treatment in Korea

Presbyopia, the age-related loss of near vision, could soon be treated successfully

Medico Remedies gets GMP compliance certificate from SMDC, Ukraine

SMDC is a participating authority under Pharmaceutical Inspection Cooperation Scheme (PIC/S)

Lupin partners with Sadoz to commercialise Ranibizumab biosimilar

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A

DKSH and Bayer partner across multiple markets in Southeast Asia

Aayush Wellness to form subsidiary in Singapore to drive Southeast Asia expansion

This strategic expansion marks a significant step in the company's global growth strategy