Raichur, Karnataka-based Shilpa Medicare has got South Korean Food and Drug Administration (KFDA) approval for Ambroxol HCL and Gemcitabine HCL after submitting drug master files (DMFs). Both are cancer midications. | |
| The company in a press release said after submission of DMFs, the KFDA officials inspected the company's manufacturing facilities in November and then gave approval. |
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| Vishnukanth Bhutada, managing director of the company said "This is an important achievement for us as it is the first regulatory approval and also it is the first company to get approval for Gemcitabine HCL (Oncology) active pharma ingredient (API) from KFDA in India." |
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| The company has already filed DMF for Gemcitabine HCL in 27 European countries. Gemcitabine HCL is going off patent soon. |
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| "Many reputed companies in Europe, India and US have started working with the company for Gemcitabine HCL. The company wants to become a significant player by capturing large chunk of market share," Bhutada. |
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