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.

Briefs: Alembic Pharmaceuticals and Veerhealth Care

The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market

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

Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg

The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA

Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval

Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well

Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals

Eugia Pharma Specialities receives 7 observations from USFDA for Unit II

Gland Pharma appoints Satnam Singh Loomba as COO

Before joining Gland, Loomba was associated with Shalina Labs, Harman Finochem, Aurobindo Pharma, Sun Pharmaceuticals and Ranabaxy Laboratories.

Briefs: Granules India

Granules India received approval from Brazilian Health Regulatory Agency ANVISA

Hikal receives Brazilian GMP certification and USFDA EIR for Bangalore and Panoli facilities

Univar Solutions expands specialty pharmaceutical and nutraceutical ingredient portfolios with Grace Syloid FP Silica

Agreement provides customers in the majority of Europe* access to supply through Univar Solutions distribution network