SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services

The inspection concluded with zero Form 483 observations

Philogen withdraws marketing authorization application for Nidlegy in EU

The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls

Teijin Pharma receives approval for additional indication for XEOMIN in Japan

Glenmark Pharmaceuticals launches TEVIMBRA in India

TEVIMBRA is a uniquely designed anti-PD-1 monoclonal antibody developed by BeiGene (now BeOne Medicines)

Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma

J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA

Biocon Biologics collaborates with National Cancer Society Malaysia

The program will start with providing bTrastuzumab to cancer patients facing treatment delays due to budget constraints

Unichem receives Form 483 from USFDA with 3 observations for Roha API facility

The company will provide the necessary response to USFDA within stipulated 15 days

Granules India receives Form 483 with 1 observation from USFDA for Bonthapally API unit 1

Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume

Biocon concludes a Rs 4,500 crore equity fundraise through QIP

The proceeds from the QIP will be utiized for purchase of outstanding optionally convertible debentures

USFDA concludes inspection of NATCO’s Pharma Division, Kothur

The company received seven observations in the Form-483