New manufacturing facility dedicated to the production of active pharmaceutical ingredients (APIs) and high potency active pharmaceutical ingredients (HPAPIs)
USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
J. B. Chemicals & Pharmaceuticals has informed that the acquisition of the Razel franchise from Glenmark Pharmaceuticals Limited has been successfully completed.
Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval
His experience covers a wide range of areas including advisory services in the field of accounting, taxation, corporate and commercial laws, and regulatory matters
ADCelerate delivers Phase I appropriate antibody-drug conjugate (ADC) drug substance and drug product for Investigational New Drug (IND) submission
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