USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit

The inspection closed with zero observations

Briefs: Natco Pharma and Panacea Biotec

Panacea Biotec has announced the launch of its new range of high-quality pediatric food & nutritional products

Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam

The company will submit its comprehensive response on these observations to the US FDA

Ampath expands its footprint in Andhra Pradesh

Launched Pathology Laboratory in Vijayawada offering a wide range of best-in-class diagnostic services with over 2500+ tests

Samsung Biologics and Pfizer collaborate for long-term manufacturing of biosimilars portfolio

Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio

Merck gets favourable verdict in patent infringement lawsuit related to Bridion

Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.

Croma-Pharma enrolls first patient in hyaluronic acid dermal filler clinical trial in China

The randomised, multi-centre, evaluator blinded, parallel group, active controlled Phase 3 trial is being led by Lanhzou Biotechnique Development

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer

Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities

Milla receives first cycle FDA approval for Dexmedetomidine Hydrochloride Injection

Indoco's Baddi facility receives EUGMP certification from Health Authority of Germany

The EU certification will support supplies of drug products registered in Europe, from this manufacturing site