Mumbai: Pharmaceutical firm Glenmark said on 30 May it has received ANDA (abbreviated new drug application) approval for its anti-inflammatory and anti-diabetic drugs and will soon commence marketing and distribution of these products in the US market.
Glenmark Generics Ltd (GGL), a subsidiary of Glenmark Pharmaceuticals, has received the ANDA approval for Mometasone Furoate Ointment, Mometasone Furoate Cream and Metformin Hydrochloride Tablets, the company said in a filing to the Bombay Stock Exchange.
GGL now has a portfolio of 32 generic products for the US market and over 35 ANDAs awaiting USFDA approval process.
The total sales for the two Mometasone Furoate products in the 12 month period ending 31 March, were over $29 million, while, Metformin Hydrochloride used in the treatment of diabetics had a total sales of over $158 million for the year ended 31 March as per IMS Health.
Mometasone would be manufactured at Glenmark’s USFDA approved Baddi unit in Himachal Pradesh, the company added.
GGL had earlier acquired US manufacturing rights for a line of Chobetasol Propionate dermatology products through a US-based pharmaceutical development company.
The company’s shares were trading at Rs681, down 0.01% on BSE in the afternoon.
Lupin gets tentative USFDA nod for epilepsy drug
Lupin Ltd said on 30 May it had got tentative approval from the US Food and Drug Administration to make and market multiple strengths of topiramate tablets.
The tablet, used for the treatment of seizures, is a generic version of epilepsy drug Topamax, owned by Ortho-McNeil Pharmaceutical Inc, a unit of Johnson & Johnson.
Lupin has got approval to market dosages of 25 mg, 50 mg, 100 mg and 200 mg, the company said in a statement.
Topamax had sales of about $2.2 billion in the year ended March 2008, Lupin said citing US market research firm IMS Health. Reuters