USFDA concludes inspection of Cipla unit’s manufacturing facility with zero observations
Cipla Ltd. said that the United States Food and Drug Administration (USFDA) recently completed an inspection at the manufacturing facility of the company’s arm InvaGen Pharmaceuticals Inc. with zero observations.
In a filing to the stock exchanges the pharmaceutical company said that a routine current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at InvaGen’s manufacturing facility located in Fall River, Massachusetts, US, between April 24 to May 1.
Current Good Manufacturing Practices provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. It ensures that each batch of products will meet quality standards so that consumers know they are both safe and effective.
The inspection concluded with zero Form-483 observation, Cipla informed the bourses.
According to the USFDA, Form 483 is issued to a company after the conclusion of an inspection when the investigator observed that any food, drug, or device has been adulterated or held under conditions whereby it may become injurious to health.
Earlier Cipla’s Pithampur unit was issued eight inspectional observations by the USFDA after inspecting the plant during February 6-17 this year.
Last month, Cipla signed a perpetual license agreement with Switzerland-based Novartis Pharma AG to manufacture and market Galvus and Galvus combination brands which are used in the treatment of type 2 diabetes from January 1, 2026.
In March, the drug major sold a 51.18 percent stake in Cipla Quality Chemical Industries Ltd (CQCIL), Uganda, for USD 25-30 million to Africa Capitalworks (ACW) SSA.