The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
Investment in new plant meets increasing demand for functional excipients for oral drug delivery
Wanbury receives CEP approval from EDQM for launch of Dextromethorphan API
Agreement further expands Aptar Pharma’s leading respiratory portfolio
The companies will combine Nanoform’s Biologics platform with the Celanese VitalDose Drug Delivery platform to further optimize controlled release of biologics
Multi-year collaboration focuses on development of biodegradable antimicrobial peptides with broad application possibilities in the areas of skin care and healthcare
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug
Chobhe brings over 30 years of extensive experience in quality and regulatory management within the pharmaceutical industry
Also received tentative approval for 137 mg
The new Injectable Facility housed in Akums Healthcare started commercial production on 22nd August 2024, with a capacity of 362 million units annually
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