Alembic Limited

.: ACTIVITIES

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Activities pertaining to APIs/ Bulk Drugs Development

We develop cost-effective and eco-friendly processes for drugs and their intermediates. We have gained significant expertise in developing processes for macrolides and ketolides apart from handling various organic reactions. The non-infringing / 1st expiry processes developed by R&D lead Alembic to file DMF’s with US FDA. Process development of API for generic markets remains the key focus. Alembic is one of the two organisations in India which produce phosgene based chemicals.

Equipped with the state of art world class analytical instruments like XRD, LC/MS/MS, Proton and carbon NMR, our Analytical Development laboratory is the backbone for development and validation of analytical methods besides making impurity profiles and quantification of polymorphs. As many as 100 scientists work on process innovation and simplification, cycle time reduction and continuous process improvement.

The Company’s R & D strengths are in developing intellectual property in the area of non-infringing processes and resolving complex chemistry challenges. A strong IPR cell at Alembic Ltd. facilitates the scientists in creation and protection of intellectual property with necessary documentation.

Our operations are supported by well documented systems and procedures and are ISO-9000 certified. A separate department called DQA (Development QA) is dedicated to R&D and ADL to guide the scientists for achieving compliance with respect to QA and RA requirements.

Our fully equipped Kilo lab, pilot plant and manufacturing plants and their sophisticated infrastructure give us a competitive edge in R&D operations.

	FERMENTATION RESEARCH Alembic has pioneered the fermentation of antibiotics. In 1961, we introduced Penicillin. That was followed by the launch of Erythromycin fermentation in India, in 1971, and then recently we introduced Cephalosporin-C. A major part of our R&D effort is devoted to microbiology. Activities at the Micro Research and Development Lab include

	Maintenance and preservation of industrial strains

	Productivity improvement of strains by mutation

	Random as well as rational selection method

	Primary, secondary and final screening of the improved isolates at the shake flask level and evaluation of cheap raw material at the shake flask level towards the development of cost effective process

	Activities at the Pilot Plant include

	Evaluation of improved isolates at different scale (from 150L to 2000L fermenters)

	Medium optimization studies

	Fermenter design studies and feasibility studies of gradual replacement of manual/ mechanical operations by Distributed Control System

It is our constant endeavor to optimize and improve imported technology to suit local conditions.

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