The approval paves the way for consolidating the company’s position in Kenya and other African markets as part of its global expansion plans
These announcements are in line with Croda Pharma’s strategy to “Empower Biologics Delivery” and follows news on investments, earlier this year, to expand Croda Pharma’s global manufacturing capabilities to enable the next generation vaccines and therapeutic drugs.
Bourgoin early development hub broadens offerings for oral solid dose formulations
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region
Cipla has received 8 inspectional observations in Form 483
It will help upgrade the infrastructure and technologies of the country's biopharmaceuticals and in-vitro diagnostic industry
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.
A committee of two Joint Drugs Controllers has been constituted at CDSCO to monitor the process of inspection, reporting, and subsequent action to ensure compliance to the Drugs & Cosmetics Act, 1940
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