Strides Arcolab Ltd Bangalore gets USFDA approval for Methoxsalen
June 25, 2014: Strides Arcolab, a successful pharmaceutical organization, has well established itself in India as a producer of specialty generic drugs and biopharmaceutical agents. Apart from these two major categories, Strides has carved a name for itself for being among the world’s biggest manufacturer of soft gelatin capsules. It has also acquired Stelis biopharmaceuticals, which focusses on the development of biosimilars and its supply to the regulated US and European markets.
Based in Bengaluru, this pharma organization boasts of a state of the art manufacturing and research facility in 5 sites across the country, a presence in 75 countries, and an outstanding sales and commercial group to establish business relationships with the world to sell their products.
Their KRS Gardens site is the lead area for the manufacture of oral dosage forms, including capsules and tablets. This site recently was cleared by the USFDA, which now makes it capable of supplying generics and capsule shells to North America.
The latest feather in their cap is the USFDA approval of their Methoxsalen capsules. This product would be made available in 10 mg capsules and produced in the Bengaluru facitlity, which has been cleared by the local and international regulatory bodies.
Methoxsalen is a drug used in the management of skin conditions such as psoriasis, eczema, contact dermatitis and vitiligo. The drug acts best when used along with a secondary means of treatment, such as exposing the affected part of the skin to UV-A light. Different forms of cutaneous lymphomas have also been effectively controlled using Methoxalen, where it functions by altering the biochemical pathways in these damaged cells. Currently, the US drug market for Methoxsalen crosses US $13 million, which thus makes this product very viable in International markets.
Needless to say, this is a big move for Strides with a good potential and opportunity to further expand its global presence.
Dr. Jay Shinde