FORMULATIONS DEVELOPMENT CAPABILITIES
Our team is experienced in developing and filing F2F, PIV, Non-infringing formulations & etc.
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Formulation Development Capabilities
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Analytical Development Capabilities
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Stability Studies Testing Capabilities
- Parenteral & Oral Solid Dosages Formulations (Oncology and Non-Oncology)
- Dedicated area with isolator to handle potent molecules.
- Dosage form development incudes:
- Aqueous Injections
- Non-Aqueous Injections
- Lyophilized Powder for Injections
- Oral Solid Dosages Formulations
- Tablets
- Hard Gelatin Capsules
- Analytical Method Development for Drug Substances & Drug Products
- Analytical Method Verification for Raw Materials & Drug Substances
- Analytical Method Validation for Drug Products
- Analytical Method Transfer for Drug Substances & Drug Products
- Real time, Intermediate and Accelerated chambers
- Stability testing (All ICH Zones)
- Stability monitoring through Protocol
- Data monitoring
- Stability testing reports
