Three commercial scale consecutive batches that are manufactured and placed on stability which are used as input for the NDA.
Glossary
Registration batches
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 | Clinical Trial Materials | Process Development | Promotions & Moves | Solid Dosage/Creams/Ointments
Metrics Adds Senior Formulation Scientist
Mascarenas to oversee formulation and process development of early-phase oral dosage forms
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APIs | Breaking News | Capsules | Clinical Trials | Formulation Development | Industry News | Process Development | Solid Dosage/Semi-solids
Dr. Reddy’s Opens Center of Excellence in India
New site will offer fully integrated formulation development services
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Breaking News | Capsules | Clinical Trial Materials | Clinical Trials | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Industry News | Lyophilization | Process Development
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Bioassay Development | Breaking News | Capsules | Drug Development | Extractables and Leachables | Facilities | Fill/Finish | Formulation Development | GMPs/GCPs | Industry News | Lyophilization | Methods Development | Process Development | Toxicology
Almac Doubles Development Capacity
Adds new non-GMP facility and two analytical labs
