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Gemshi Pharma Research and Development (R&D) Overview
The Company’s R&D strengths are in developing intellectual property in non-infringing processes and resolving complex chemistry challenges.Gemshi Pharma is in the process of developing new drug delivery systems, new dosage formulations, and applying new technology for better processes.
The R&D Center provides a nurturing environment to a multi-disciplinary team of over many scientists striving for excellence.
The Centre meets cGLP requirements, and is focused on the areas of organic synthesis, analytical research, dosage form development, pharmacology, bio-equivalence studies and drug delivery systems.
The instrumentation and analytical knowledge base at the Centre facilitate:
Complete impurity profiling in all products developed.
Development of analytical methods and specifications from raw materials, to non-compendial finished products.
In-house synthesis of reagents for analysing organolithiums and noble metals.
Accelerated and real-time stability studies.
This reflects the Company’s commitment towards developing innovative technologies and creating a knowledge base in chemical synthesis, high quality generic formulations and development of drug delivery systems.
Our Strengths
1. Excellent infrastructure
The Centre is well equipped to handle various developmental challenges in the areas of oral and parenteral medications. Specifically, the available infrastructure includes:
Dedicated area and labs to handle potent substances like hormones.
Process Development and Scale-up Labs attached to the manufacturing unit.
An NDDS laboratory with specialized capabilities like nano-technology, hot melt extrusion, etc.
A unit to develop parenteral dosage forms ranging from vials to ampoules to pre-filled syringes to large volume parenterals.
A unit to develop opthalmic and nasal products using the BFS technology.
Supporting dedicated packaging development labs with multifeeder BQS machinery capable of various packs including multi-product-in-a-blister.
Dedicated analytical laboratories with UPLC’s, ion chromatography, an amino acid analyser, particle size and particle surface area analyser, hot stage microscopy, USP Type III and Type IV apparatus etc.
A bio-equivalence laboratory approved by various regulatory bodies like USFDA, MHRA and WHO etc.
2. Excellent talent pool
many scientists dedicated to development of generic formulations, many of which are first-to-file.
Many patent applications have been filed by a dedicated IP team.
The scientific team is supported by two separate project management teams dedicated to oral solids and parenteral portfolios.
Our Achievements and Capabilities
The Centre is capable of developing, scaling up and commercializing various dosage forms spread across tablets, capsules, soft gels, oral liquids, injectables (solutions, suspensions, lyophilized, etc.), and ophthalmic (three piece and BFS) and nasal delivery systems.The focus is to develop products for international markets, including specialized markets like .
The center is mainly capable to generate & deliver following category