Shilpa Medicare Ltd has submitted its DMF's for Ambroxol HCL and Gemcitabine HCL to South Korean FDA in 2007 and the South Korea FDA (KFDA) officials inspected the company's manufacturing facilities in last week of Nov. 2007.
The KFDA officials satisfied with the compliance of GMP Standards have approved the company's facilities for Gemcitabine HCL and Ambroxol HCL.
This is an important achievement for the company, as it is the first regulatory approval for the company and also it is the first company to get approval for Gemcitabine HCL (Oncology API) from KFDA in India. This proves that Shilpa can confidently face the other regulatory inspections for Gemcitabine HCL and other oncology API's from EDQM, France, TGA Australia, UK MHRA, and US FDA.
The company has already filed EDMF for Gemcitabine HCL in 27 European countries and also with EDQM for Certificate of Suitability. Gemcitabine HCL is going off the patent soon and worldwide market size in 2006 was US $1193 millions and growing very fast every year. Many reputed companies in Europe, India and US have started working with the company, for Gemcitabine HCL.
Gemcitabine HCL is a cancer (Oncology) medication is used in the treatment of cancers of pancreas lungs and breast. Gemcitabine interferes with the growth of cancer cells and slows their growth and stops the spread of cancer cell in the body.
Ambroxol HCL is an expectorant and mucolytic. The company is the largest manufacturer of API in India and already it has received Certificate of Suitability from EDQM, France.
With this KFDA approval the company's products will be well accepted by customers in South Korea.