Caplin Point receives EIR from FDA with Zero 483 observations

The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.

Nutraceuticals CDMO manufacturer Crius Group to adopt 100% AI-based project implementation

NutrifyGenie AI, a leading AI-driven platform, was integral in designing scientifically differentiated formulations for a multinational client

CDSCO approves Wockhardt’s Mignaf for treatment of community acquired bacterial pneumonia

Wockhardt plans to launch Miqnaf in the Indian market in coming few months

Aarti Drugs receives EIR from USFDA for Tarapur API facility

This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP

ANVISA inspection received from Brazil Health Regulatory Agency at Wanbury Tanuku facility

The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe

Rusan Pharma achieves GMP approvals from TGA (Australia) and ANVISA (Brazil) for its manufacturing facility in Kandla SEZ

The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market

CuraTeQ Biologics receives positive opinion for biosimilar Zefylti

Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells

Supriya Lifescience expands global footprint with Esketamine Hydrochloride approval

Esketamine hydrochloride is a vital drug to be used for treating mental illness and is likely to significantly impact the LATAM market

Granules India update on USFDA inspection at Gagillapur facility

Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA

Trimax Biosciences receives CEP Filing submission of Propafenone Hydrochloride from EDQM