The Hindu Business Line : Natco Pharma gets USFDA nod for facility

NATCO Pharma Ltd has announced that it has obtained the approval of the USFDA for its finished dosages formulations facility located at Kothur in Mahaboobnagar district of Andhra Pradesh.

In a press release here on Monday, the company said the Kothur facility with four modules is versatile and is spread over about 20 acres. The facility is supported by an independent R&D lab and has a dedicated module for aerosols and independent stores, services and quality control areas.

Additional capacity is being added at the formulations unit at Kothur, to increase the current four modules to 10 modules by end of March 2006. The expansion would enable the unit manufacture different dosage forms, new drug delivery systems, parenterals, cyto-toxic formulations and ointments.

Natco Pharma's active pharmaceutical ingredients (APIs) facility at Mekaguda near here was already been approved by the USFDA.

With the approval for the finished dosage formulations unit, the company becomes one of the very few Indian pharmaceutical companies that have the USFDA approval for both APIs and finished dosage formulations.

The company is establishing a finished dosage formulations unit at Dehradun in Uttaranchal.

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