CSIR-IIIM & Racemix Molecules Ltd. sign agreement for APIs; A model for billions dollar API industry : Dr. Ram

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Jammu; 14.02.2020 : Keeping in line with Govt. move to incentivize firms to boost domestic production of Active Pharmaceutical Ingredient (APIs) and reduce dependence on imports, the CSIR-Indian Institute of Integrative Medicine, Jammu has entered into an agreement with M/S Racemix Molecules Pvt. Ltd., a Jammu based Pharmaceutical Company, to do collaborative research & development and industrial production of Active Pharmaceutical Ingredient (APIs) of the life saving drugs. While giving the detail of research and development work planned to be carried out under this agreement, Dr. Ram Vishwakarma, Director CSIR-IIIM, Jammu informed that almost all drugs are made up of two core components i.e. activated pharmaceutical ingredients, the APIs, which are the central active ingredients providing the therapeutic effect; and the excipients, chemically inactive substances other than the drug that help to deliver the medication. It was also said that for past quite sometime, 40% of world market of APIs was with India having value of multi-billion US$ which was continuously growing. There has been a regression in production & export of APIs because of the aggressive pricing policy of the countries like China which have started selling these APIs at very cheaper rate thus caused severe effect to the Indian Pharmaceutical industries involved in the production of APIs, thereby increasing their dependence on imported APIs. Dr. Ram also disclosed that this agreement signing is the follow-up action of successful developing the “know how process for fluxamime maleate” which is an antidepressant drug and now M/s Anphar is going to start the production of commercial batches in its good manufacturing practice (GMP) facility. After successful accomplishment of the lab scale synthesis of fluxamime maleate, CSIR-IIIM and M/S  Racemix Molecules Pvt. Ltd (a subsidiary of M/s Anphar) has signed the umbrella agreement under which they would work together for the synthesis of intermediates of API, production of commercial batches of fluxamime maleate and APIs of many other life-saving drugs.

Witnessing the current World situation where various diseases are spread world wide and most of the countries have stopped the export of drugs, CSIR-IIIM with state of the art research facilities like (i) cGMP facility, (ii) Kilo Lab. for the scaling up and manufacturing of select high value drug molecules and their intermediates; (iii) analytical facilities viz. HPLC, GC, NMR, Mass, wet analysis; (iv) established chemical research labs. and (v) fermentation technology set up, has took the initiative to actively support the API industry and to develop our own APIs in our country itself. This will not only generate huge job opportunities but also develop national health security in India. Seeing the today’s world health crisis, this agreement will be a landmark and will work as a model to develop the API industry which can value about hundreds of billion dollar, maintained Dr. Ram.

The agreement was signed by the Dr. Ram Vishwakarma, Director, CSIR-IIIM, Jammu and Ankit Gupta, Director, M/S Racemix Molecules Pvt. Ltd. today at Jammu, in the presence of other senior functionaries from both sides.

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