The Indoco Remedies drug company on July 15 said it received a warning letter from the US health regulator for its oral dose installation in Goa.
The company received a warning letter from the United States Food and Drug Administration (USFDA) as a result of the inspection conducted in January 2019, Indoco Remedies said in a presentation to BSE.
"The company will respond to the warning letter within the stipulated time and is already working with the current consultant on good manufacturing practices (cGMP) to ensure that the remediation activities are completed in accordance with the expectations of the USFDA," he added.
"We have already done considerable remediation work and will continue to implement the necessary additional corrective actions," said Dr. Aditi Kare Panandikar of Indoco Remedies.
The company is committed to complying with GMP standards and providing quality products to its customers and patients around the world, he added.
Indoco Remedies, however, did not disclose the issues raised by the regulator in its warning letter.
The facility received six observations on Form 483 and was classified as & # 39; OAI & # 39; (official action indicated & # 39;) in March 2019, according to the presentation.
The company responded to these observations with a detailed remediation plan, whose implementation is still ongoing, he said.
The company has a new approved abbreviated medication application (ANDA, for its acronym in English) of this site, whose annual income is around 3 million rupees. There are four ANDAs pending for this service and these approvals can be withheld until all problems are resolved, he added.
Shares of Indoco Remedies were trading at Rs 159.90 per program in BSE, up 5.91 percent from their previous close.