On Thursday, Indian pharmaceutical company MSN Laboratories Pvt. Ltd. said the U.S. Food and Drug Administration (FDA) has tentatively approved the company’s Abbreviated New Drug Application (ANDA) for a generic version of cangrelor.
The product will be manufactured at a state-of-the-art injectable facility approved by the FDA and Medicines and Healthcare products Regulatory Agency (MHRA) in Hyderabad, Telangana, India.
Available under the brand name Kengreal in the United States, cangrelor is a P2Y12 inhibitor used as an antiplatelet drug for intravenous application. The FDA approved Kengreal in June 2015.
The drug is used during the percutaneous coronary intervention (PCI) to reduce the risk of blood clots and heart attack.
Chiesi, an Italian family-controlled global pharmaceutical company based in Parma, Emilia-Romagna, manufactures the brand Kengreal.
The FDA tentative approval comes close on the heels of the company receiving the Drugs Controller General of India’s approval for Canreal, a generic version of cangrelor.
MSN Labs, which develops Canreal, said in a statement, “Besides reflecting the capability of MSN Laboratories to deliver products of high-quality standards, this development also provides impetus to our growth aspirations in an important market such as the U.S.”
In the European Union, the drug is sold under the brand name Kengrexal.
About MSN Labs
MSN is one of the fastest-growing research-based pharmaceutical companies in India. Founded in 2003 with a mission to make health care affordable, the company has nine Active Pharmaceutical Ingredients (APIs) and five finished dosage facilities across Hyderabad, Myanmar, and the US.
