The Visakhapatnam Special Economic Zone (VSEZ) on Friday granted approval for production of Remdesivir injections at a unit on its premises at Duvvada within hours of receiving applications from Dr. Reddy’s Lab in this regard.
VSEZ Development Commissioner A. Rama Mohan Reddy said that all the formalities pertaining to the approval were completed on a war-footing, considering the increasing requirement of the life-saving drug in view of the rapid spread of infections during the second wave of coronavirus pandemic.
Ratification by UAC
“In normal circumstances, such proposals is sent to the Unit Approval Committee (UAC). But given the exigency, the same was approved by a committee of the VSEZ, and the same will now be sent to UAC for ratification,” said Mr. Rama Mohan Reddy.
As per the proposal submitted to VSEZ, the unit that has a valid drug licence issued on April 30 for three years will now manufacture 3.5 lakh vials of 100mg/ml and 7 lakh vials of 500mg/5 ml of Remdesivir injections. The approval was granted under the Rule 19(2) of SEZ Rules 2006, said Mr. Rama Mohan Reddy.
The product is likely to be available by June, said Dr. Reddy Lab’s unit head of Mr. Menon.
The VSEZ has already given approval for manufacturing Remdesivir in the form of API (Active Pharmaceutical Ingredient) at the Hetero Drugs unit at the Nakkapalli SEZ. It was sent to their DTA unit in Hyderabad for the final shape of vials and marketed back to Andhra Pradesh for use. So far, the Hetero Drugs unit at Nakkapalli has manufactured and supplied about 89.29 kg of API, he said.
Molnupiravir API
According to Mr. Rama Mohan Reddy, the Laurus labs of the APSEZ has supplied 38.3 million HCQ tablets during the first wave of the pandemic last year to various countries such as South Africa, Singapore, Burma, Belgium, Canada and USA. It is now in the planning stage to manufacture Molnupiravir.
He also said that the VSEZ had given approvals for manufacture of Molnupiravir in API form to the Honour Labs at the Nakkapalli SEZ, to the tune of 100 Kg/annum on a war-footing and is already in the process of manufacturing.
