- Lupin Ltd. has received a warning letter from the Food and Drug Administration for manufacturing issues at two facilities responsible for making many of its close-to-market products.
- The FDA issued its letter on Nov. 6, about six months after the agency inspected Lupin's facilities located in the Indian state of Goa and city of Indore. Those investigations resulted in nine total Form 483 observations, which indicate violations of the Food, Drug and Cosmetic Act.
- Nilesh Gupta, Lupin's managing director, explained during an investor call that the Goa and Indore plants produce roughly 50 drugs that currently have approval applications filed with the FDA, according to a Livemint report. The company is considering moving production for about a dozen drugs poised to bring in substantial revenues to other manufacturing sites.
In spite of rapid growth, India's pharmaceutical market has struggled with quality control issues. Many drugmakers with operations in the country have been found guilty of current good manufacturing practice (cGMP) violations, leading to a spate of warning letters from U.S. regulators.
"The facilities are not inspected as often as in the U.S., and the companies often have more warning of when the inspectors are coming," Prabir Basu, a pharmaceutical consultant, told BioPharma Dive earlier this year.
Lupin is no stranger to FDA criticism. In May, for instance, the company confirmed that inspectors reported eight Form 483 observations at its facility in Aurangabad.
This latest warning, however, appears to carry much more weight. Lupin's stock sunk more than 17% after announcing receipt of the FDA's letter, trading at 859.90 Indian rupees ($13.25) apiece by close of market Tuesday.
"We are deeply disappointed to have received this outcome," Lupin said in a Nov. 7 statement to the National Stock Exchange of India. "While there will be no disruption of existing product supplies from either of these locations, there will likely be a delay of new product approvals from these two facilities."
"We uphold quality and compliance issues with the utmost seriousness and remain fully committed to be compliant with cGMP quality standards across all our facilities," the company added. "We plan to address the concerns raised by the USFDA expeditiously and will work with the USFDA to resolve these issues a the earliest."
Analysts note the Goa and Indore plants are responsible for about 20% of Lupin's total sales, and that production setbacks for some of its generic drugs — such as blood sugar medicines Glumetza (metformin hydrochloride) and Fortamet (metformin hydrochloride) — will be tough pills to swallow, according to Bloomberg Quint.
"The warning letter will mean future approvals will be halted. It will be difficult for Lupin to offset the slowdown in Glumetza and Fortamet with this move," Amey Chalke, an analyst at HDFC Securities, told Bloomberg Quint.