NATCO Pharma Limited is pleased to announce that the Government of India has stayed the suspension of its Albupax manufacturing (product) license. Albupax is a nanotechnology based drug and is the first generic version of the international brand - Abraxane® of Abraxis Bioscience Inc., USA.

Albupax consists of Paclitaxel in an Albumin-bound nanoparticle form and is used in the treatment of breast cancer. NATCO’S manufacturing license was suspended by the Drugs Controller General of India (DCGI), allegedly for not passing the test measuring endotoxin levels.

Subsequently, NATCO appealed to the Government of India under the provisions of the Drugs & Cosmetics Rules against the suspension order. Among other things, NATCO pleaded that:

a)     The testing methods used to evaluate nanotechnology based protein-bound formulations are highly complex and variable. An appropriate test method needs to be employed to test such products.

b)    The product has been aggressively priced at a fraction of the innovator’s price

c)     The product was received well by the medical fraternity as well as patients from various parts of India.

NATCO is thankful to the Government for its decision in this regard. NATCO stands by its commitment to provide high quality and life saving drugs at affordable price to Indian patients.

NATCO would announce its future plans shortly.