After plugging the gap on the manufacturing front of its Covid-19 vaccine, Zydus Cadila is ready to roll out more than 40 lakh doses of ZyCovD, News18 has learnt.
The company, headquartered in Ahmedabad, has submitted batches containing 35-40 lakh doses of ZyCoV-D for the final safety checks at the country’s apex laboratory, Central Drug Laboratory (CDL), in Kasauli, Himachal Pradesh.
Most of the latest batches of ZyCoV-D at the CDL are expected to cater towards the order of 1 crore doses placed by the central government last November.
While in August 2021, ZyCoV-D was given emergency approval by the Drug Controller General of India (DCGI), the company due to its ongoing manufacturing issues had submitted 2.37 lakh doses till January this year.
Now, these latest batches are being manufactured at the company’s newly commissioned state-of-the-art, Zydus Vaccine Technology Excellence Centre, at the Zydus Biotech Park in Ahmedabad. The facility was audited and approved by DCGI along with state drug regulator and an official from the CDL.
ZyCoV-D, which is touted as the world’s first plasmid DNA intradermal Covid-19 vaccine, which is administered using a painless needle-free system in three doses.
The testing of these batches may take longer than usual considering the company has changed the manufacturing processes along with the change in the facility. “The CDL, now, needs to validate the processes again, which may take 15-20 days, instead of the usual 10-12 days,” a senior government official from the health ministry told News18.
“The company has now indicated that the flow of batches for testing at CDL will be regular,” he said while adding that these doses are most likely to be the part of the government’s order of one crore doses.
However, the company also plans to make the vaccine available in the private market.
The vaccine will be priced at Rs 265 per dose while the PharmaJet needle-free system Tropis applicator will be offered at Rs 93 per dose, excluding GST. The vaccine will be administered on Day 0, Day 28 and Day 56.
Drug substance for the vaccine is manufactured by Zydus VTEC with the manufacturing process and material transfers within the plant being automated.
Apart from Zydus’ own manufacturing, the company has also entered into a definitive agreement with a contract manufacturer firm, Shilpa Medicare, to produce an undisclosed amount of doses of ZyCoV-D.
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