01 2ScinoPharm Taiwan, Ltd
02 1ScinoPharm Taiwan. Ltd
03 1Thermo Fisher Scientific Cork Limited
01 1Alvogen Korea Co., Ltd.
02 1Korea United Pharmaceutical Co., Ltd.
03 1Samil Pharmaceutical Co., Ltd.
04 1Samoh Pharmaceutical Co., Ltd.
01 4Topotecan hydrochloride
01 3Taiwan
02 1U.S.A
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2016-03-02
Registration Number : 20120703-207-I-40-01(1)
Manufacturer Name : ScinoPharm Taiwan, Ltd
Manufacturer Address : No. 1, Nan-Ke 8th Road, Tainan Science-Based Industrial Park, Shan-Hua, Tainan 74144_...
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2012-07-03
Registration Number : 20120703-207-I-40-01
Manufacturer Name : ScinoPharm Taiwan, Ltd
Manufacturer Address : No.1 Nan-Ke 8th Road Shan-Hua, Tainan 74144, Taiwan
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2018-02-02
Registration Number : 20120703-207-I-40-01(A)
Manufacturer Name : ScinoPharm Taiwan. Ltd
Manufacturer Address : No1, Nan-Ke 8th Road, Shan-Hua, Tainan 74144, Taiwan
Registrant Name : Samil Pharmaceutical Co., Ltd.
Registration Date : 2013-03-07
Registration Number : 20130307-207-I-129-03
Manufacturer Name : Thermo Fisher Scientific Cor...
Manufacturer Address : Currabinny, Carrigaline, Co. Cork, P43 AY66, Ireland
A Topotecan Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Topotecan Hydrochloride, including repackagers and relabelers. The FDA regulates Topotecan Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Topotecan Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Topotecan Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Topotecan Hydrochloride supplier is an individual or a company that provides Topotecan Hydrochloride active pharmaceutical ingredient (API) or Topotecan Hydrochloride finished formulations upon request. The Topotecan Hydrochloride suppliers may include Topotecan Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Topotecan Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Topotecan Hydrochloride Drug Master File in Korea (Topotecan Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Topotecan Hydrochloride. The MFDS reviews the Topotecan Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Topotecan Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Topotecan Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Topotecan Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Topotecan Hydrochloride suppliers with KDMF on PharmaCompass.
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