Strides Pharma up 4% as arm receives tentative USFDA approval for Dolutegravir tablets
Strides Pharma up 4% as arm receives tentative USFDA approval for Dolutegravir tablets
Strides Pharma Science’s share price experienced a 4 percent increase, reaching Rs 488.95 in early trade on September 15. This surge in share price can be attributed to a significant development involving one of its subsidiary companies, Strides Pharma Global Pte. Limited, located in Singapore. This subsidiary has received “tentative approval” from the United States Food & Drug Administration (USFDA) for a pharmaceutical product known as Dolutegravir 50mg tablets.
Dolutegravir is a crucial medication used in the treatment of HIV infection. The term “tentative approval” means that the USFDA has reviewed the application for this medication and found it to be generally acceptable for use, pending full approval. Until final approval is granted, the product cannot be marketed or sold in the United States.
What makes this approval significant is that Strides Pharma Global’s Dolutegravir 50mg tablets have been deemed “bioequivalent” and “therapeutically equivalent” to the Reference Listed Drug (RLD), which, in this case, is Tivicay Tablets produced by ViiV Healthcare Company. This essentially means that Strides Pharma’s version of the medication contains the same active ingredients and is expected to produce the same therapeutic effects as the reference drug.
ViiV Healthcare Company is renowned for its specialization in developing medications for the treatment and prevention of HIV. Tivicay Tablets, as the reference drug, have a well-established presence in the field of HIV therapy.
The rise in Strides Pharma Science’s share price can be attributed to the positive news of receiving tentative approval for a generic version of this essential HIV medication. Such regulatory approvals are typically viewed favorably by investors, as they open up potential revenue and market opportunities for the company. However, it’s important to keep in mind that final approval from the USFDA is still pending, and market dynamics can continue to influence the share price in the future.
The products, referring to Strides Pharma Global Pte. Limited’s Dolutegravir 50mg tablets, are set to be manufactured at Strides Pharma Science’s facility in Bengaluru, India. This facility will be responsible for producing the medication in compliance with regulatory standards.
The expectation is that the tentative approval received from the USFDA will transition into full approval once certain patents that constrain the production and marketing of the generic medication expire. Pharmaceutical companies often need to wait until existing patents on a reference drug expire before they can introduce generic versions to the market. Once these constraints are lifted, Strides Pharma Global can proceed with the marketing and distribution of their Dolutegravir 50mg tablets in the United States.
It’s worth noting that Strides Pharma Science has a substantial presence in the generic pharmaceutical market in the United States. The company has filed a total of 260 Abbreviated New Drug Applications (ANDAs) with the USFDA, which includes the portfolio acquired from Endo at Chestnut Ridge. Out of these filings, over 230 ANDAs have already received approval from the USFDA.
Looking ahead, Strides Pharma Science has ambitious plans for the US market. They are aiming to launch approximately 60 new products over the course of three years. These new product launches are a strategic move to expand their product portfolio and gain a stronger foothold in the competitive US pharmaceutical market. Such expansion plans can be significant for the company’s growth and market presence, as they can tap into a broader range of pharmaceutical offerings for various medical conditions.
In recent months, Strides Pharma Global Pte. Limited, a subsidiary of Strides Pharma Science, has been making significant strides in the pharmaceutical industry. On September 9, the subsidiary achieved a noteworthy milestone by receiving approval from the United States Food and Drug Administration (USFDA) for Sevelamer Carbonate for Oral Suspension USP in two strengths, 0.8g and 2.4g. This medication is used to manage high phosphate levels in patients with chronic kidney disease, and the approval allows the subsidiary to manufacture and market these formulations in the US market.
Additionally, on September 7, Strides Pharma Science’s board approved the acquisition of a 100 percent shareholding in Strides Pharma Services Private Limited (SPSPL). SPSPL was previously a wholly-owned subsidiary of Arco Lab Private Limited, which itself is a wholly-owned subsidiary of Strides Pharma Science. Following this acquisition, SPSPL will become a direct wholly-owned subsidiary of the parent company, strengthening Strides Pharma Science’s strategic positioning in the pharmaceutical industry.
Furthermore, in August, Strides Pharma Global Pte. Limited secured approval from the US health regulator for a generic version of Mycophenolate Mofetil for oral suspension, an essential medication indicated for organ transplant patients to prevent organ rejection. These series of approvals, acquisitions, and product launches signify the company’s commitment to expanding its product portfolio and enhancing its presence in the competitive pharmaceutical market.
