Zydus Cadila has upgraded its facility to produce 6 lakh vials of lyophilized 100 mg remdesivir injection at its Gujarat-based Vadodara and Ahmedabad facilities following the Gujarat Food and Drug Control Administration (FDCA) and Drugs Controller General of India (DCGI) regulatory approvals. The company is further planning to expand the capacity up to 9 lakh vials based on the growing demand.
“There is scope of producing 9 lakh vials from Zydus Cadila facilities based on the demand. Zydus is currently marketing lyophilized 100 mg remdesivir injection for Rs. 2,800, which is the cheapest version of remdesivir drug available today. The company is giving the medicine at government rate contract of Rs 2,100 which is the cheapest remdesivir version available in the market today,” according to Gujarat FDCA Commissioner Dr H G Koshia.
Cipla and Hetero remdesivir priced it at Rs. 5,400 and Rs. 4,800 respectively for 100 mg. A patient generally requires a dosage of 6 injections for 5 days with 200 mg on the first day and remaining 100 mg daily each for five days. Zydus Cadila has been granted licenses for both domestic manufacturing and for exports in the wake of growing demand of remdesivir lyophilized 100 mg injection. Lyophilized injection is considered as an alternative to oral solid dosage forms for better patient compliance especially in hospitalized patients. Lyophilized injections are also prescribed to attain maximum bioavailability and stability in patients suffering from a number of diseases.
Remdesivir is prescribed for hospitalised patients who are on oxygen. The drug has to take for five days, 200 mg IV (intravenous) on day 1 followed by 100 mg IV daily for four days. Zydus is among the several Indian generic drug makers that have licensing agreements with US-based Gilead Sciences to produce remdesivir, the antiviral that has been approved in the country as an emergency treatment to fight the coronavirus outbreak.
Cipla, Hetero and Mylan have till now launched the generic versions of remdesivir in India. Jubilant Life Sciences, Dr Reddy's and Syngene are other companies that have licenses from Gilead to manufacture and distribute remdesivir generic versions.
Meanwhile, Zydus Cadila’s COVID-19 vaccine ZyCoV-D candidate has been found safe in early-stage human trial. Zydus plans to complete late-stage trials for ZyCoV-D by February or March, 2021. The Gujarat FDCA had also granted WHO-GMP certificate to Zydus Cadila for the development of vaccine ZyCoV-D based on the manufacturing audit conducted jointly by the Gujarat FDCA and the DCGI.
Zydus Cadila had received approval from DCGI to initiate phase 1 and phase 2 human clinical trials of ZyCoV-D. Company has successfully established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe.