Indoco Remedies handed FDA warning letter
- Indoco Remedies, a mid-sized Indian drugmaker, is the latest foreign manufacturer to run afoul of FDA inspections, announcing in a notice to stock exchanges last week that it had been issued a warning letter on Mar. 27.
- An August inspection of Indoco's Goa plant turned up six possible violations, but the firm was able to successfully resolve four of them to the FDA's satisfaction.
- The U.S. regulator remained concerned, however, about two observations tied to one specific product that Indoco manufactures for another company — triggering the warning letter, which has not yet been posted publicly.
While FDA warning letters to Indian drugmakers are nothing new, shareholders in Indoco did not receive the news well, pushing the company's shares to a multi-year low.
The violations flagged by the FDA are tied to production of the opthalmic drug latanoprost, Bloomberg Quint reported.
Indoco said it is fully committed to resolving the issue, noting also that it will continue to supply products from the Goa plant to customers in the U.S., indicating the firm has not been placed on the FDA's import ban list.
Indian API and finished dose manufacturers continue to be tripped up by the FDA's stepped-up oversight of the sector. Indoco is the sixth such firm to be cited by the regulator so far in 2017, and even big-name companies like Wockhardt and Dr. Reddy's have struggled to meet regulatory standards.
- Indoco Remedies Market notice
- Bloomberg Quint Indoco Remedies Hits 22-Month Low On U.S. FDA’s Warning
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