Sun Pharma gets USFDA approval for generic Prometh syrup
18 Mar 2010
Sun Pharmaceutical Industries Ltd has received approval from the US Food and Drug Administration (USFDA) for its abridged new drug application (ANDA) for `Promethazine Hydrochloride' and `Codeine Phosphate Oral Syrup', 6.25 mg/5 ml and 10mg/5ml, respectively.
The Promethazine Hydrochloride with Codeine Phosphate Oral Syrup is bioequivalent to Prometh Codeine of Actavis Mid Atlantic LLC.
This product has annual sales of approximately $16 million in the US.
This medication is used to treat symptoms caused by the common cold, flu, allergies, or other breathing Illnesses such as sinusitis, bronchitis, Sun Pharma said in a filing with the Bombay Stock Exchange (BSE).
Prometh is the registered trademark of Actavis Mid Atlantic LLC.
Sun Pharmaceutical Industries Ltd is an integrated, speciality pharmaceutical company, which manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, the US and several other markets across the world.
In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopedics. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms.