In 2018 NATCO and Alvogen had filed an Abbreviated New Drug Application (ANDA) with PIV certification for the generic version of the product
NATCO Pharmaceuticals, Hyderabad; Alembic Pharmaceuticals, Vadodara; Gufic Biosciences Ltd., Gujarat; Emcure Pharmaceuticals, Pune; and Lyka, Gujarat are new manufacturers
Natco has withdrawn its application filed with the Indian Patent Office, seeking Compulsory License against Lilly for Baricitinib for Covid-19 in India
The company will be requesting a Compulsory License based on emergency use and in light of the grave and serious public health emergency across India due to the Pandemic
The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths
NATCO's partner BPI plans to launch 2.5 mg, 5 mg and 7.5 mg strengths of the product shortly within the next few weeks.
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