USFDA inspection at Cipla manufacturing facility in Goa, warning letter issued
New Delhi: Drug firm Cipla recently announced that it has received a warning letter from USFDA for its goa Manufacturing Facility.
Pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, further to the earlier communication on the Goa manufacturing facility inspection conducted from 16-27 September 2019 by the United States Food and Drug Administration (USFDA), the Company has received a Warning Letter from USFDA. The Company remains committed to maintaining the highest standards of compliance and will work closely with the agency to comprehensively address all the observations.
The copy of this is also submitted to BSE Ltd, National Stock Exchange of India Ltd and SOCIETE DE LA BOURSE DE LUXEMBOURG.This information is provided by the Rajendra Chopra, Company Secretary & Compliance Officer, Cipla Limited
Medical Dialogues had earlier reported that in January 2020, Cipla had received observations from the USFDA for its Goa manufacturing facility. It had then said that the developments will not have any material impact on the company's US business at this stage.
"The United States Food and Drug Administration (USFDA) has classified the inspection conducted at its Goa manufacturing facility from 16-27 September 2019 as Official Action Indicated (OAI). The company does not believe that this will have any material impact on the US business at this stage," the drug major said in an exchange filing.
Founded in 1935, Cipla an Indian multinational Pharmaceutical company. Driven by the same purpose, Cipla has extended its presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. To make healthcare more affordable globally, the company has deep presence in the key markets of India, South Africa, the U.S. among other economies of the emerging world.