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
The company received 1 (One) observation in the Form-483
TFOS is indicated for the treatment of pulmonary arterial hypertension
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
Both these innovations are aimed at reducing the risk of relapse post CAR T cell therapy
Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma
The increase in revenue and profits for the year was driven by business growth in the US market and growth in our subsidiaries in Canada & Brazil.
Lenalidomide capsules are a prescription medicine used in adults for the treatment of multiple myeloma.
Natco launched pomalidomide under their brand NAT-POMALIDOMIDE in strengths of 1 mg, 2 mg, 3 mg and 4 mg capsules
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic, and prostate cancer
At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure
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