USFDA concludes inspection at Cipla Qidong facility with zero observations

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-03-02 06:59 GMT   |   Update On 2024-03-21 09:35 GMT
Advertisement

Mumbai: Cipla has announced that the United States Food and Drug Administration (USFDA) has concluded a pre-approval inspection with zero Form 483 observations at the manufacturing facility of Cipla (Jiangsu) Pharmaceutical Co., Ltd. (subsidiary of the Company) located in Qidong, Jiangsu Province, China.

The facility was inspected from 26th February, 2024 to 1st March, 2024.

"we hereby notify that a pre-approval inspection was conducted by the United States Food and Drug Administration (USFDA) at the manufacturing facility of Cipla (Jiangsu) Pharmaceutical Co., Ltd. (subsidiary of the Company) located in Qidong, Jiangsu Province, China from 26th February, 2024 to 1st March, 2024," the Company stated in a BSE filing.
Advertisement
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.

Read also: Cipla, Dr Reddys and other Indian Pharma companies now in race to develop Wegovy versions

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, the U.S. among other economies of the emerging world.

Read also: CDSCO Panel grants Cipla's Prescribing Information update for Bovine Lipid Extract Surfactant Suspension

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News