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Cipla gets 1 inspectional observation from USFDA for Maha facility
Mumbai: Pharma giant Cipla has informed through a recent BSE filing that the Company has received 1 inspectional observation in Form 483 from the United States Food and Drug Administration (USFDA) at the conclusion of the inspection at Kurkumbh manufacturing facility.
The inspection was held from 29th April, 2024 to 8th May, 2024.
"A routine current Good Manufacturing Practices (cGMP) inspection was conducted by the United States Food and Drug Administration (USFDA) at manufacturing facility of the Company located in Kurkumbh, Maharashtra, India from 29th April, 2024 to 8th May, 2024," Cipla stated.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
"The Company will work closely with the USFDA and is committed to address this observation comprehensively within stipulated time," Drug major added.
In April, the Medical Dialogues team reported that Cipla received six inspectional observations in Form 483 from the USFDA at the conclusion of a routine current Good Manufacturing Practices (cGMP) inspection at the company's manufacturing facility located in Patalganga, Maharashtra, India.
Read also: Cipla gets 6 USFDA observations for Maha facility
Cipla Limited is an Indian multinational pharmaceutical and biotechnology company headquartered in Mumbai, India. Khwaja Abdul Hamied founded the Company in 1935 in Mumbai. Cipla has extended its presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. The Company is also deepening its presence in the key markets of India, South Africa, and the U.S. among other economies of the emerging world.
Read also: Cipla Gets CDSCO Panel Nod To import, market Human Insulin inhalation powder with inhaler
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751