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The facility had received six observations in Form 483s and was classified as Official Action Indicated in March. The company responded to these observations with a detailed remediation plan and the implementation is still on-going.
"We have already done considerable remediation work and shall continue to implement necessary additional corrective actions," said Managing Director Aditi Kare Panandikar. "We are committed to being current Good Manufacturing Practices (cGMP) compliant and supplying quality products to our customers and the patients across the globe."
Indoco will respond to the warning letter within stipulated time and is already working with cGMP consultant to ensure that the remediation activities are completed in line with the USFDA's expectations, the company said in a statement.
The company has one approved abbreviated new drug application (ANDA) from this site, the annual revenue of which is around Rs 3 crore. There are four pending ANDAs from this facility and these approvals may be withheld till all the issues are resolved, it said.
Indoco Remedies is a fully integrated, research-oriented pharma company with presence in 55 countries. The Rs 980 crore company employs over 5,500 people including more than 300 scientists. It has nine manufacturing facilities.
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