Sun Pharma Gets CDSCO Panel Nod For Alfuzosin-Tadalafil FDC Post-Marketing Study
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-08-10 07:00 GMT | Update On 2025-08-10 07:00 GMT
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New Delhi: Drugmaker Sun Pharmaceutical Laboratories Ltd has been granted conditional approval by the Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), to conduct an Active Post Marketing Surveillance (PMS) study of its fixed-dose combination (FDC) drug: Alfuzosin Hydrochloride IP (ER) 10 mg + Tadalafil IP 5 mg uncoated bilayer tablet.
This approval came during the 6th SEC (Urology) meeting held on 22nd July 2025, where the firm presented its Active PMS protocol as required under Form CT-23 dated 25.04.2025.
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