Natco Pharma Ltd has received an approval from the US FDA, for its facility for the manufacture of finished dosage formulations situated at Kothur in Mahaboobnagar District, Andhra Pradesh.
The company's Kothur unit is a composite, ultra modern and state of the art facility. The manufacturing facilities and equipment range from simple mixers and tablet making machines to soft get capsule machines, pellet making facilities and capsule filling (powder) machines.
The facility, which is a 6000 sq. meters, has four modules, is very versatile, and is spread over around 20 acres. The area is equipped with the latest machinery and testing apparatus. The facility is supported by an independent R&D lab, has a dedicated module for aerosols and has independent stores, services and quality control areas. The facility has already received UK MHRA approval. The unit also has an ISO 9001 certification, the company has already filed several ANDAs.
The company firmly believes that outsourcing from quality Indian companies would be the order of the day, and accordingly has taken up expansion of its finished dosage manufacturing facility at Kothur. Additional capacity is being added at the formulations unit at Kothur (about 100,000 sq. ft.) increasing the current four modules to ten modules by end of March, 2006 to enable manufacture different dosage forms, new drug delivery systems, parenterals, cyto-toxic formulations and ointments. Once completed, the company's facility would be one of the biggest and most modern.
The company's active pharmaceutical ingredients facility at Mekaguda in Mahaboobnagar District in Andhra Pradesh is already approved by the US FDA. With the approval for the finished dosage formulations unit as well by the US FDA, the company will be one of the very few Indian companies, which have US FDA approval for both APIs and finished dosage formulations.
The company is in the process of establishing a finished dosage formulations unit at Dehradoon in Uttaranchal and once established, would be shifting all manufacture for domestic markets to Dehradoon. In the Kothur facility, the company would concentrate on manufacturing finished dosages exclusively for US and European markets. It is actively pursuing its stated objective of entering these markets and the first consignment is expected to be dispatched in December 2005.