Pharma firm Glenmark today said that it has received the approval of US health regulator USFDA to introduce generic theophylline tablets, used for treating asthma and other lung diseases, in the American nation.
Glenmark Generics Inc (GGI), the subsidiary of Glenmark Generics Ltd, will start marketing and distributing the medicine, in 400mg and 600 mg strengths, with immediate effect.
In a statement, GGI said it has been "granted ANDA (Abbreviated New Drug Application) approval from the United States Food & Drug Administration (USFDA) for theophylline extended-release tablets, the generic version of Purdue Pharmaceutical Products, LP Uniphyl".
The market for theophylline tablets is estimated to be USD 8 million per annum and GGI expects a "successful launch, based on limited competition existing in this niche segment".
Theophylline extended-release tablets are indicated for treatment of symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases such as emphysema and chronic bronchitis.
After this approval, Glenmark's current portfolio has increased to 56 generic drugs for distribution in the US. It also has over 50 pending ANDAs filed with the USFDA for approvals.
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"In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement the growth of the existing pipeline and portfolio," the statement said.
The shares of Glenmark Pharmaceuticals were trading flat at Rs 278.50 on the Bombay Stock Exchange this afternoon.