Aizant Drug Research Solutions Pvt. Ltd. offer service "Contract Formulation Development & Analytical Development (CDMO)"
Basic Information
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Trade Type
Offer Service
Service Name
Contract Formulation Development & Analytical Development (CDMO)
Service Provider(s)
Specifications
- Dosage Form: Covers solid forms (tablets, capsules, powder-filled sachets, granules, pellets, mini-tablets in capsules, MUPS), injectables (liquid, lyophilized, suspension, microspheres, depot, pre-filled syringes/cartridges), topicals, and oral liquids.
- Excipient Selection: Formulation work spans customized release liquid formulations and complex generics (NCE-1, Paragraph IV, niche generics, FDCs), requiring case-by-case excipient and vehicle selection.
- Bioavailability Enhancement: Includes modified/extended/sustained/delayed/gastro-resistant and dual-release profiles, along with hot melt extrusion to address bioavailability-limited molecules.
- Scale Capability: Supports lifecycle product development from clinical trial material supplies through IP and regulatory support, including 505(b)(2) and NDA development.
- GMP Certified: Fee-for-service contract R&D operates with ANDA/NADA filing support, positioning formulation output for regulated, GMP-manufactured commercial supply.
Documents
WHO-GMP Certificate
Other
FDA
GMP
ISO
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