This story is from May 7, 2021

Wardha lab prepares first batch of 25,000 Rem vials

Wardha lab prepares first batch of 25,000 Rem vials
Nagpur: Genetek Lifesciences Private Limited on Thursday produced the first batch of 25,000 vials of Remdesivir at its laboratory at Sewagram in Wardha district.
“The first batch would be put through seven-day sterility test from Friday. On May 15, the batch is likely to be handed over to Hetero Labs,” said Mahendra Kshirsagar, owner and managing director of Genetek.

US-based Gilead Sciences, which holds the patent for the anti-viral drug, had granted licence to seven pharmaceutical companies in India, including Hetero Labs Limited, to produce the drug. Genetek had procured loan licenses from Hetero for five years to manufacture the drug.
“We would be able to produce 25,000 vials daily for seven days,” said Kshirsagar.
Union minister for road transport and highways, Nitin Gadkari on Thursday visited Genetek. Gadkari has been instrumental in starting Remdesivir production in Vidarbha.
Underlining the significance of producing the anti-viral drug here, Gadkari said it was challenging to get approvals from the department concerned as the drug is patented. “We had to seek a way out as Remdesivir shortage was leading to many complications, including Covid deaths,” he said.

Kshirsagar said following the two-day ingredient testing, Genetek labs’ team of 25 scientists managed to complete filling of the first batch.
In yet another development, vials meant for testing of the ‘Form fill seal’ (FFS) technology, in which medical-grade plastic would be used as vials, too were prepared. They would be put through separate suitability and stability testing.
FFS testing would take place for one-and-half month following which approval would be sought. “We would be able to produce 2.5 lakhs vials of Remdesivir in plastic vials but the quantity would depend on availability of raw material and intermediates which need to be brought from foreign countries,” said Kshirsagar.
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