Breaking News
1. Massive fire at Varanasi railway station parking, over 200 vehicles gutted      2. First Sambhal, Then Ajmer: Ex-CJI Chandrachud Under Fire For ‘Opening Floodgates’ Of Survey Pleas      3. Chennai Airport Shut, Trains Hit As Cyclone Fengal Intensifies      4. 2nd Hindu Priest Arrested In Bangladesh Amid Protests: ISKCON Member      5. Man climbs mobile tower in Kota, threatens suicide over his tractor seizure      6. Body of 2-year-old, his grandmother recovered from river in Manipur      7. Bodies of six abducted in Jiribam found; Kerala CM and UDF leaders argue over BJP defection      8. Several flights, trains disrupted as Delhi covered in smog, visibility down      9. Delhi air quality: AQI at this Delhi station above 1500      10. Pawan Kalyan condemns deaths of 2 Hindu girls in Pakistan who faced ‘atrocities’      11. India not to travel to Pakistan for Champions Trophy, wants its matches in Dubai      12. India not to travel to Pakistan for Champions Trophy, wants its matches in Dubai      13. Samosas, cakes meant for Himachal Pradesh CM Sukhu served to his security staff instead; CID probe on      14. We remain undeterred: Australian outlet on Canada's ban after Jaishankar presser      15. 'We Are Here Only As Pilgrims, Do Our Work & Leave': CJI DY Chandrachud Bids Farewell To Supreme Court      16. PM Narendra Modi slams NC-Cong's Article 370 resolution: 'Conspiracy against Kashmir'      17. IPL Auction: James Anderson registers for first time      18. Sharda Sinha dies: Huma Qureshi, Manoj Bajpayee, and others grieve singer's death      19. Man shot in gang war outside Raipur jail, sparks outrage over security lapses      20. After MK Stalin, Udhayanidhi warns Vijay, TVK: Only DMK will win in 2026     

Glenmark Pharmaceuticals Gains USFDA Approval for Apremilast Tablets, Targets Skin Care Sector

  • Posted on October 17, 2023
  • Business
  • By Arijit Dutta
  • 299 Views

Glenmark Pharmaceuticals, a prominent player in the pharmaceutical industry, achieved a significant milestone as it received final approval from the US Food & Drug Administration (USFDA) for its Apremilast Tablets. These tablets are intended for the treatment of plaque psoriasis and oral ulcers, further enhancing Glenmark's presence in the dermatology sector.

Glenmark Pharmaceuticals Gains USFDA Approval for Apremilast Tablets, Targets Skin Care Sector Image Source -www.health.economictimes.indiatimes.com

Glenmark Pharmaceuticals, a prominent player in the pharmaceutical industry, achieved a significant milestone as it received final approval from the US Food & Drug Administration (USFDA) for its Apremilast Tablets. These tablets are intended for the treatment of plaque psoriasis and oral ulcers, further enhancing Glenmark's presence in the dermatology sector.

The US FDA's approval covers Apremilast Tablets in three distinct strengths: 10 mg, 20 mg, and 30 mg. These tablets are a generic alternative to Amgen Inc.'s Otezla tablets, which come with the same strengths. Glenmark's announcement highlighted the potential of Apremilast Tablets, underlining their role in treating a range of skin conditions.

Otezla tablets, which serve a similar purpose, achieved staggering annual sales of approximately USD 3.7 billion in the 12 months leading up to August 2023, as reported by IQVIA sales data. This approval positions Glenmark Pharmaceuticals to tap into this lucrative market and cater to the needs of patients with psoriasis arthritis and moderate to severe plaque psoriasis, a specific skin ailment.

Glenmark Pharma, with an impressive portfolio of 188 products authorized for distribution in the US market, currently has 50 Abbreviated New Drug Applications (ANDAs) pending approval with the US FDA. This showcases the company's commitment to expanding its presence in the pharmaceutical industry.

In addition to its dermatology offerings, Glenmark Pharmaceuticals maintains a robust presence across various segments, including branded, generic, and over-the-counter (OTC) products. It primarily focuses on respiratory, dermatology, and oncology products.

Also Read: Oil Prices Fall Over $1 As Hopes For Venezuela Deal Rise And Middle East Crisis Stays Local

Operating across four continents with ten manufacturing facilities and a presence in over 80 countries, Glenmark is well-positioned to cater to a global clientele. Moreover, in a strategic move, the pharma giant's subsidiary, Glenmark Specialty SA, recently entered into a distribution and license agreement with Cosmo Pharmaceuticals NV. The partnership aims to introduce Winlevi (Clascoterone cream 1%) in the European and South African markets. Glenmark will have exclusive rights to commercialize Winlevi in 15 EU countries, South Africa, and the UK, offering a promising solution for acne treatment in patients aged 12 years and older.

Glenmark's success is reflected in the stock market, with Glenmark shares trading 0.63 percent higher at Rs 802.50 on the Bombay Stock Exchange (BSE) at 9.43 AM. This marks the third consecutive day of positive performance for the company's shares.

Author
No Image
Author
Arijit Dutta

You May Also Like