Formulations development

This area of research and development is engaged in developing Specialty/ Branded formulations for Global market. Formulations development is carried out to produce stable and clinically safe and effective formulation. Different formulations are being developed to meet the unmet needs and specific regulatory requirement of various regulatory agencies

The various dosage forms developed as Tablets (conventional, chewable dispersible, mouth dissolving, extended release, enteric coated etc.), Capsules, Semi-solids (ointment, cream, gel, lotion) and Liquids (solution, suspension) focusing on therapeutic categories like anti-hypertensive, anti-psychotic, anti-convulsant, anti-depressant, anti-fungal, anti-inflammatory, anti-psoriasis, anti-acne etc.

There is a well-equipped state-of-art formulations development facility for all of these dosage forms, located at Sinnar, Nashik, with highly qualified scientists working under different areas.

The team involved in the various stages of formulations development comprises formulations development scientists, analytical development scientists, packaging development scientist and the technology transfer group.

NCE-CMC

This area of research focuses on CMC part of NCE research. This division comprises of teams of process development scientists, analytical development scientists and formulation development scientists. These teams are involved in giving analytical support to discovery chemistry and developing the processes for the new chemical entities identified as the lead molecules. Process for the lead molecule is developed and optimized from various aspects such as feasibility, commercial viability, cost, green chemistry, scalability etc. This research group also does salt optimization, preliminary polymorphic study, impurity profiling and formulations development of lead molecules selected as clinical candidates.

Structural elucidation, complete characterization, method developments, stability studies, method validation and study the physicochemical properties of NCEs are also performed at this facility. In-house developed technologies are transferred to GMP approved sites for manufacturing clinical and developmental lots of drug substances and drug products. CMC section of IND and NDA submissions are prepared by this unit.

There is a well-equipped state-of-art process and analytical facility having modern instruments e.g. NMR, LC-MS, XRD, DSC, TGA etc. located at Mahape, Navi Mumbai, with about 40 scientists working in different research areas.

Additional facility is being set up at Mahape for Specialty formulations and Bioanalytical.

Sinnar

The formulation development laboratory in Sinnar is spread over 3670 sq m and employs over 50 scientists, supported by dedicated analytical laboratories. This team caters to the new product and product enhancements requirements for the Indian, semi-regulated and Latin American markets.

In 1999-2000, the team developed 45 products, of which 20 were launched in the domestic and export markets.

Mahape

The Glenmark Research Centre at Mahape, Navi Mumbai [New Bombay] houses the second formulation development laboratory that develops products for the regulated markets including USA & EU.

A team of over 70 scientists is employed at this facility with dedicated analytical laboratories as well.