 "pharma, medicine, drugs")
Strides Pharma Science Limited (Strides) has announced that its wholly-owned subsidiary company, Strides Pharma Global Pte Limited, Singapore has been approved by the United States Food & Drug Administration (USFDA) for Efavirenz (600mg), Emtricitabine (200mg), Tenofovir Disproxil Fumurate (300mg), and (EET) tablets.
The company said that its product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Atripla Tablets of Gilead Sciences LLC. The recent approval adds to the company's portfolio of medicines in the therapeutic category. Now, the company has a total of 15 products in this category, the company said in a regulatory filing with the BSE.
The EET tablet has a market potential of $7.5 million per IQVIA in the US market. The product will be manufactured at the company's facility located in Bengaluru. The PEPFAR approval means that the company can participate in global donor-funded programs that procure this medicine in about 10 countries.
The company has 260 cumulative ANDA filings with USFDA, this includes the recently acquired portfolio from Endo at Chestnut Ridge. The company aims to launch about 60 new products in the next three years in the US market.
Strides is a global pharmaceutical company with its headquarters in Bengaluru, India. The company's global manufacturing sites are located in India, Singapore, Italy, Kenya, and the United States of America.
