“The formalities were completed by Dr. Reddy’s Lab within a few hours of receiving the application.”
The Visakhapatnam Special Economic Zone (VSEZ) on Friday approved the manufacture of remdesivir injections in a unit in their building in Duvvada within hours of receiving requests from Dr. Reddy’s lab.
VSEZ Development Commissioner A. Rama Mohan Reddy said all formalities related to the war-based permit have been completed amid the increasing need for the life-saving drug amid the rapid spread of infections during the second wave of the coronavirus pandemic.
Ratification by UAC
“Under normal circumstances, such proposals are sent to the Unit Approval Committee (UAC). However, given the need, this has been approved by a committee of the VSEZ and is now being sent to the UAC for ratification, ”said Rama Mohan Reddy.
According to the proposal submitted to the VSEZ, the unit, which was issued a valid three-year drug license on April 30, will now be 3.5 lakh vials of 100 mg / ml and 7 lakh vials of 500 mg / 5 ml Making Remdesivir Injections. The permit was granted under Rule 19 (2) of the 2006 SEZ Rules, said Rama Mohan Reddy.
The product is expected to be available in June, said Dr. Reddy Labs Head of Department from Mr. Menon.
The VSEZ has already approved the production of Remdesivir in the form of API (Active Pharmaceutical Ingredient) in the Hetero Drugs Unit of the Nakkapalli SEZ. It was sent to the DTA department in Hyderabad for the final shape of the vials and marked back to Andhra Pradesh for use. So far, the Hetero Drugs unit in Nakkapalli has manufactured and shipped about 89.29 kg of API, he said.
Molnupiravir API
According to Rama Mohan Reddy, APSEZ’s Laurus laboratories shipped 38.3 million HCQ tablets to various countries such as South Africa, Singapore, Burma, Belgium, Canada and the United States during the first wave of the pandemic last year. The production of molnupiravir is currently being planned.
He also said that VSEZ has given Nakkapalli SEZ’s Honor Labs permits to manufacture molnupiravir in API form at a rate of 100 kg / year on a war basis and is already in the process of manufacturing.