Shilpa Medicare to make ZYCOV-D drug substance

Hyderabad’s Shilpa Medicare will make the drug substance (raw material) for Cadila Healthcare’s DNA plasmid vaccine ZYCOV-D at its Dharwad facility. ZYCOV-D is the world’s first approved DNA vaccine, and it is also the first Covid-19 vaccine in India to be approved for use in adolescents 12-years and above.

The volumes, however, have not been disclosed at the moment. Under the agreement, Shilpa Biologicals, a subsidiary of Shilpa Medicare, will manufacture the drug substance of the vaccine, while Zydus will do the filling-packaging and distribution of the vaccine. In a notification to the stock exchanges, both the firms said Shilpa Biologicals will make the drug substance for ZYCOV-D from its integrated R&D and manufacturing centre at Dharwad, Karnataka. “The targeted production of the ZYCOV-D vaccine from this facility will be mutually agreed upon by both parties,” the statement said.

Cadila Healthcare (Zydus Cadila) had earlier indicated that it was looking for partners to scale up the production of ZYCOV-D. The company has invested ~400-500 crore in developing the ZYCOV-D so far, which includes setting up of manufacturing plants. “We have re-purposed an existing plant where we are now producing, and our new plant will be ready by the end of July. By August, we should have a capacity to make 10 million doses a month and by the end of this year, we would have made 50 million doses of ZYCOV-D,” Zydus Cadila MD Sharvil Patel had said in July.

Shilpa Biologicals’ Dharwad facility would cater to other biologic products like DNA vaccines, adenoviral, and subunit vaccines, monoclonal antibodies, and fusion proteins. It is also making the Sputnik V vaccine for the Russian Direct Investment Fund.