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Results For "Natco-Pharma"

66 News Found

NATCO Pharma transfers Lenalidomide ANDA to Arrow
News | August 04, 2021

NATCO Pharma transfers Lenalidomide ANDA to Arrow

Arrow is the marketing partner in US


NATCO Pharma receives USFDA approval for Lenalidomide capsules
Policy | May 24, 2021

NATCO Pharma receives USFDA approval for Lenalidomide capsules

NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.


NATCO launches Everolimus tablets, 1 mg
News | October 31, 2025

NATCO launches Everolimus tablets, 1 mg

Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients in kidney and liver transplantation


Delhi High Court refuses to restrain Natco from manufacturing spinal muscular atrophy drug
News | October 10, 2025

Delhi High Court refuses to restrain Natco from manufacturing spinal muscular atrophy drug

The Court dismissed Swiss drugmaker Roche’s plea for interim injunction


NATCO launches Bosentan Tablets for oral suspension in US with 180-day exclusivity
News | August 21, 2025

NATCO launches Bosentan Tablets for oral suspension in US with 180-day exclusivity

NATCO holds the first-to-file status for this product and will have 180-day generic drug exclusivity


USFDA concludes inspection of NATCO’s  Pharma Division, Kothur
Drug Approval | June 20, 2025

USFDA concludes inspection of NATCO’s Pharma Division, Kothur

The company received seven observations in the Form-483


USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
Drug Approval | June 17, 2025

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received one observation in the Form-483


USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
Drug Approval | June 13, 2025

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received 1 (One) observation in the Form-483


NATCO, Lupin receive ANDA approval for Bosentan tablets for oral suspension
Drug Approval | February 10, 2025

NATCO, Lupin receive ANDA approval for Bosentan tablets for oral suspension

TFOS is indicated for the treatment of pulmonary arterial hypertension


NATCO announces approval of its ANDA for Everolimus tablets for Oral Suspension
Drug Approval | January 31, 2025

NATCO announces approval of its ANDA for Everolimus tablets for Oral Suspension

Everolimus TFOS is a kinase inhibitor indicated in adult and paediatric patients aged one year and older with tuberous sclerosis complex for the treatment of subependymal giant cell astrocytoma