Shilpa Medicare to make drug substance for Cadila's ZyCoV-D vaccine

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 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 that Shilpa Biologicals will make the drug substance for ZyCoV-D from its integrated R&D and manufacturing center 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 indicated earlier that it was looking for partners to scale up the production of ZyCoV-D. The company has invested Rs 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 mn doses a month and by the end of this year, we would have made 50 mn 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 (RDIF).

ZyCoV-D is a needle-free vaccine administered using The PharmaJet, a needle free applicator, which ensures painless intradermal vaccine delivery. The Company will transfer the ZyCoV-D technology to Shilpa Biologicals.

The vaccine got a nod from India’s drug regulator in August and is yet to be launched in the market.