The FDA-recommended testing and filing actions to be taken by a pharmaceutical firm when it changes the manufacturing processes of a drug product that has already been approved via an NDA or ANDA.
Glossary
Scale-Up and Post-Approval Changes (SUPAC)
02.27.12
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Promotions & Moves
Akebia Therapeutics Names CMO
Jain to lead clinical development of the company’s HIF pipeline
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Breaking News | Facilities | Industry News | Solid Dosage/Creams/Ointments | Solid Dosage/Semi-solids
Recro Gainesville Expands Mfg. Capabilities
Installs new tableting equipment and grows development team
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Pharmaceutical CMO Installs High-Speed Bottling Line
Pharma Tech Industries employs at its Missouri facility.Released by: Pharma Tech Industries
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Bio News | Biologics, Proteins, Vaccines | Industry News
Dr. Reddy’s Expands Biomanufacturing Capabilities
Becomes first Indian company to install FlexFactory single-use platform
