- Glenmark’s new Hydrocortisone Valerate Ointment USP 0.2 percent is a generic version of Sun Pharmaceutical’s Westcort®1 Ointment 0.2 percent.
- The company is eligible for CGT exclusivity on commercialization for 180 days due to the approval.
Glenmark Pharmaceuticals Inc., a renowned Indian pharmaceutical company, has reportedly announced that it has been granted a final approval for its Hydrocortisone Valerate Ointment USP 0.2 percent by the U.S Food & Drug Administration (U.S. FDA).
Reports cite, the company’s ointment is a generic version of the Westcort®1 Ointment 0.2 percent that is produced by its fellow Indian pharmaceutical firm, Sun Pharmaceutical Industries Ltd.
According to a press release by Glenmark Pharmaceuticals, the company has also been granted with a designation of Competitive Generic Therapy (CGT) for the Hydrocortisone Valerate Ointment by the FDA. With this approval, the company is now eligible for over 180-days of CGT exclusivity on commercialization. The ointment is Glenmark’s first product to be granted CGT approval by the U.S. FDA.
The Mumbai-based company’s present portfolio consists of about 145 different products that have been authorized to be distributed inside the U.S. market and about 55 other products that are currently waiting for the ANDA approval by the FDA.
Moreover, apart from the present internal filings, the company also continues to explore & identify external development partnerships to supplement & expedite the growth of its current portfolio.
According to IQVIATM sales information, the Westcort®1 Ointment 0.2 percent market recorded annual sales numbers of about $11.1 million for the 12-month-long period that ended in October 2018.
Glenmark shares were reportedly trading in the BSE at about INR 666.4 in comparison to the previous closing number of INR 677.05. Over 89161 shares were traded during the day in 2187 different trades.
Stock prices reportedly achieved an intraday high of approximately INR 684.95 with an intraday low of about 659.6. Glenmark’s net turnover for the day was approximately INR 59,807,517.