Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.
The companies will combine Nanoform’s Biologics platform with the Celanese VitalDose Drug Delivery platform to further optimize controlled release of biologics
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
Dhiraj brings 20+ years of extensive executive-level financial expertise across various industries including Pharma, Media, Retail, and FMCG
Mirabegron Extended-Release Tablets, 50 mg is a generic equivalent of Myrbetriq® Extended-Release Tablets, 50 mg of Astellas Pharma Global Development
Vonoprazan is used in the treatment of disorders related to Gastroesophageal Reflux Disease (GERD)
He will lead the final stages of work to commission the 54,000-square-foot facility and then lead ongoing operations at the site
The new facility further improves the operational efficiency and readies the site for the completion of the new large-scale production plant
ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the USFDA
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