Shares of Aurobindo Pharma hit a two-year high of Rs 872.95, as they gained 4 per cent on the BSE in Monday’s intra-day trade after the company got US drug regulator’s approval for skin and bone infection drug.
In an exchange filing, Aurobindo said its wholly-owned subsidiary, Eugia Pharma Specialities, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Vancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial, single-dose vial. The said drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vancomycin Hydrochloride for Injection USP, by Mylan Laboratories.
Vancomycin Hydrochloride for Injection USP is indicated in adults and paediatric patients (neonates and older) for the treatment of Septicemia, Infective Endocarditis, Skin and Skin Structure Infections, Bone Infections and Lower Respiratory Tract Infections.
The product is being launched in August 2023. The approved product has an estimated market size of around $34.4 million for the twelve months ending May 2023, according to IQVIA.
This is the 164th ANDA (including 8 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products, the company said.
Meanwhile, Aurobindo has long been focused on creating an efficient API business, which is a key component in the company’s overall growth journey. As part of the ongoing strategy, the API business operations have been carved into a wholly-owned subsidiary. This move is expected to bring higher management bandwidth and more emphasis on growth and productivity within the API segment.
Last year the company had launched a Penicillin-G project in Kakinada, Andhra Pradesh, of 15,000 tonnes/annum capacity, as part of the Indian Government’s production linked incentives (PLI) scheme. The project is progressing well on time and is expected to be completed in FY24, Aurobindo said in its FY23 annual report.
The company is strategically expanding its presence in the fast-growing markets of China and India, to tap into their immense potential. It aims to invest in organic growth initiatives and synergistic business opportunities in these geographies. The commercialisation of the oral facility in Taizhou, China, will play a pivotal role in catering to businesses in Chinese, European, and other markets, the company said.