Divi's Laboratories sees a lot of potential in custom synthesis and contract manufacturing beyond 2005. The rapidly evolving pharmaceutical market scenario has necessitated the global pharma companies to focus on their core competencies and to outsource chemical manufacturing research activities for new chemical entities (NCE's). This has opened opportunities for custom synthesis manufacturers like Divi's to cater to their outsourcing requirements.
Divi's undertakes custom manufacture of APIs and advanced intermediates offering competitive advantages over the entire life cycle of the products. Several MNCs customers audit its facilities regularly in course of their custom manufacture of their products. Divi's is an ideal partner for custom synthesis, process development and manufacturing of customer's own discovery product.
It undertakes complete and acceptable validation of processes and offers its analytical expertise for generating reliable data for regulatory agencies [e.g. stability studies as ICH, validated analytical methods] and its documentation expertise for preparing draft DMFs, CoS etc. for regulatory submissions. The configuration of the existing facilities enables the company to quickly switch from one product to another in order to address the changing needs of the marketplace. The company is engaged in developing processes and customs synthesis of several API's and intermediate compounds for pharmaceutical MNCs for their discovery products that are under various phases of clinical trials.
The company established in 1990, started off as a research and consultancy firm for developing commercial processes for active pharmaceutical ingredients on a turnkey basis. After gaining recognition in the field it moved into manufacturing of APIs and intermediates in the mid-1990s and has increased its product portfolio.
It has facilities at Hyderabad and Vishakapatnam. Its thrust is to manufacture intermediates for new products to be used in clinical trials of MNCs. The company has developed skills of chiral synthesis, peptide synthesis, and nucleotide chemistry. Divi's serves about a dozen innovator companies in the US and Europe.
Generally, custom synthesis starts with small quantities and later gets scaled up to commercial lots. The main advantage of undertaking this kind of activity is that the company could end up as a preferred supplier for a particular product when the molecule becomes commercially successful and associate with the client right from the beginning of the product lifecycle. However, if the client in question fails to get approval for commercial launch then the custom manufacturer also has to bear the brunt. Realization in custom manufacture is high as the products are tailor made to suit the requirements of discovery companies.