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Research & Development
Formulation Development
Progress with a purpose
Our Formulation Development Laboratory located in Mumbai (in line with the US-FDA requirements) is well-equipped with the technology required to conduct high-quality research activities and prototype development.
R&D Capabilities:
Formulations
- High Sheer Mixer (GMP model)
- Fluid Bed Drier
- Fluid Bed Processor
- Ganscoata
- Walk–in Stability Chambers
- Dissolution Apparatus with Intrinsic Dissolution Assembly
- Bilayer Tablet Compression Machine
- Hard Gel Capsule Facility
- Blister Packing Machine with Alu–Alu Facility
- Press–Cota
- Roll Compactor
- Pelletisation Facility
- Compression of Pellets (MUPS Tablet)
- Facility for Effervescent tablets (Low RH Area)
- Reverse Laminar flow
Analyticals
- Gas Chromatography Equipment (GC)
- High Performance Liquid Chromatography(HPLC)
- High Performance Thin Layer Chromatography (HPTLC)
- Malvern Particle Size Analyzer
- FTIR
Key R&D Activities:
Novel Drug Delivery System (NDDS)
R&D in this area attempts to improve the efficiency with which the medicine is absorbed in the body. Novel Drug Delivery Systems (NDDS) efforts are directed towards:
- Controlled Release
- Novel Dosage Formulations
Abbreviated New Drug Application (ANDA)
The filing of ANDAs received a major boost after Ipca opened its wholly-owned subsidiary in New Jersey, USA. Ipca’s research endeavours are well-supported by world-class infrastructure:
- Analytical Research
- Clinical Research
- International Regulatory Affairs
- Corporate Quality Assurance
- Intellectual Property Cell
Manufacturing of generics for registration in UK/EU/South Africa/Brazil and other countries
Formulation R&D Capabilities
- Design and development of new dosage forms
- Pre-formulation studies
- Lab/pilot scale studies
- Process optimization/validation studies
- Stability studies as per ICH guidance
- Technology transfer of new products
- Technical supports to manufacturing location
- Technology and latest development up gradation to provide technically superior, process efficient and International standards product.
The group is well supported by an analytical development team, which is committed to development of analytical methodologies that provide sensitive, precise, rugged, and accurate data in minimum time. Key activities include development & validation of various analytical test procedures for Assay, Content Uniformity, Dissolution, Related Substances, Residual Solvents, other in-house test procedures and finalisation of their Specifications which will adequately evaluate desire-quality attributes.
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