Indoco Remedies Blood-thinner Apixaban gets USFDA green flag
It is used for patients with health problems caused by a blood clot.
Mumbai: Drugmaker Indoco Remedies today announced that the company has received US Food and Drug Administration (USFDA) approval for abbreviated new drug application(ANDA) for Apixaban Tablets 2.5mg & 5mg.
The products are therapeutically equivalent to the Reference Listed Drug 'Eliquis' of Bristol-Myers Squibb (BMS).
Apixaban is an anticoagulant, or blood thinner. It is used for patients with health problems caused by a blood clot.
The US market size of Apixaban Tablets is USD 11,037 million as per IMS MAT June'20 data.
Commenting on this development, Ms. Aditi Kare Panandikar, Managing Director - Indoco Remedies Ltd. said, "The receipt of approval from the US health regulator for the generic version of Apixaban Tablets is encouraging."
Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented pharma Company with presence in 55 countries.
Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets.
The Company has 9 manufacturing facilities, 6 of which are for FDFs and 3 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility.