**Subject: Requirement of Stability Data for COpp**
This notice, reference number F.No. 120119DCPT195, issued on 2j2120 by the Government of India, specifically the Central Drugs Standard Control Organization (CDSCO), New Drugs Division, located at FDA Bhawan, Kotla Road, New Delhi – 110002, addresses concerns regarding the requirement of stability data on COpp. Further details may be obtained from the Office of the Drugs Controller General India, one of the Health Services.
Key Entities Referenced
Drugs Controller General India: A key regulatory authority in India responsible for drug approval and regulation.
New Drugs Division: A division within the Central Drugs Standard Control Organization, likely responsible for the approval of new drugs.
FDA Bhawan, Kotla Road, New Delhi: Location of Central Drugs Standard Control Organization office.
Stability Data: Data related to the stability of drug products, a critical requirement for ensuring their safety and efficacy over time.
COpp a ems: Appears to be a typographical error, possibly referring to 'compendiums' or 'applications,' related to issues raised regarding stability data requirements.
Central Drugs Standard Control Organization: The national regulatory body in India responsible for the approval of drugs, cosmetics, and medical devices.
F.No. 12-01/19-DC(PT-195)
Be Government of India
Central on, one of Health Services
Office or 9S Standard Control Organization
of Drugs Controller General (India)
(New Drugs Division)
FDA Bhawan, Kotla Road,
New Delhi-110002
Date: 2j)2120
NOTICE
Subject: Requirement of Stability Data for COpp —
a ems have been raised regarding requirement of stability data on the