Drug News

Lupin Achieves Satisfactory VAI Status from FDA for Its Indian Facility Despite Identified Deficiencies

Lupin, a prominent generics manufacturer, has encountered its fair share of challenges with the U.S. Food and Drug Administration (FDA) in recent times. While the recent write-up from the FDA regarding Lupin’s Pithampur Unit-2 facility could have been worse for the company, it still received a Voluntary Action Indicated (VAI) classification. This classification implies that the FDA identified certain “objectionable conditions or practices” during its inspection but did not deem it necessary to take immediate administrative or regulatory action. It is now up to Lupin to voluntarily address the identified deficiencies and take appropriate remedial measures.

Unfortunately, the specific nature of the deficiencies uncovered by the FDA at the Pithampur plant has not been disclosed by Lupin. However, the company expressed overall satisfaction with the outcome of the inspection. Nilesh Gupta, the managing director of Lupin, highlighted the significance of achieving a VAI status for the facility. He emphasized the company’s determination to rebuild its reputation for being best-in-class in terms of quality and compliance. Gupta also mentioned the company’s anticipation of new product approvals and the launch of ophthalmic products from the Pithampur facility, indicating their commitment to further growth and development.

Lupin’s operations extend beyond the Pithampur Unit-2 facility. The company operates a total of 15 manufacturing sites and seven research centers globally, employing a workforce of over 20,000 individuals. However, Lupin has faced several FDA rebukes in recent months. In November, the company disclosed receiving a Form 483—a document issued by the FDA to notify a company of observed violations during an inspection—at its active pharmaceutical ingredients (API) plant in Mandideep. Remarkably, this marked the fourth such reprimand Lupin had received from the FDA within just nine weeks, each targeting a different facility in India.

Prior to the Mandideep incident, Lupin faced scrutiny from the FDA regarding violations found during a review of its injectables manufacturing site in Nagpur. Additionally, an astonishing 18 compliance problems were identified at its biosimilars plant in Pune. Furthermore, Lupin revealed that it had suspended the production of drugs intended for the U.S. market at its troubled drug ingredients plant in Tarapur. The FDA had requested that Lupin provide notification before resuming operations at the facility. Lupin first acknowledged issues at the Tarapur plant in September, when the company announced receiving an FDA warning letter. However, the company did not disclose the production suspension at that time.

Despite these challenges, Lupin remains determined and optimistic about its future. The company is committed to regaining its reputation as a leader in terms of quality and compliance within the pharmaceutical industry. While setbacks have occurred, Lupin continues to strive for new product approvals and advancements in its product portfolio. By addressing the identified deficiencies and taking voluntary remedial actions, Lupin aims to rebuild its reputation and maintain its position as a key player in the generics market.


Dr. Oche Otorkpa PG Cert, MPH, PhD

Dr. Oche is a seasoned Public Health specialist who holds a post graduate certificate in Pharmacology and Therapeutics, an MPH, and a PhD both from Texila American University. He is a member of the International Society of Substance Use Professionals and a Fellow of the Royal Society for Public Health in the UK. He authored two books: "The Unseen Terrorist," published by AuthorHouse UK, and "The Night Before I Killed Addiction."
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