Hyderabad-based Natco Pharma Ltd on Tuesday said it has received the final approval from the US health regulator for its first supplemental abbreviated new drug application (sANDA) filed from its new drug formulations facility at Visakhapatnam, Andhra Pradesh.
The sANDA, submitted as 'prior approval supplement' provides for Natco's formulations facility at JNPC SEZ, Ramky Pharma City in Visakhapatnam as an alternate site for manufacture of the approved drug product for the US market, Natco Pharma said in a regulatory filing.
The company, hwoever, did not disclose the product which has been approved by the US Food and Drug Administration (USFDA) to be produced from the facility.
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