01 1ScinoPharm Taiwan, Ltd.
01 1Nogitecan Hydrochloride
01 1Taiwan
Registration Number : 307MF10045
Registrant's Address : No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 741014, Taiwan
Initial Date of Registration : 2025-03-26
Latest Date of Registration : 2025-03-26
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PharmaCompass offers a list of Topotecan Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Topotecan Hydrochloride manufacturer or Topotecan Hydrochloride supplier for your needs.
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PharmaCompass also assists you with knowing the Topotecan Hydrochloride API Price utilized in the formulation of products. Topotecan Hydrochloride API Price is not always fixed or binding as the Topotecan Hydrochloride Price is obtained through a variety of data sources. The Topotecan Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Hycamtin, NSC 609699, Topotecan Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hycamtin, NSC 609699, Topotecan Hydrochloride, including repackagers and relabelers. The FDA regulates Hycamtin, NSC 609699, Topotecan Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hycamtin, NSC 609699, 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.
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A Hycamtin, NSC 609699, Topotecan Hydrochloride supplier is an individual or a company that provides Hycamtin, NSC 609699, Topotecan Hydrochloride active pharmaceutical ingredient (API) or Hycamtin, NSC 609699, Topotecan Hydrochloride finished formulations upon request. The Hycamtin, NSC 609699, Topotecan Hydrochloride suppliers may include Hycamtin, NSC 609699, Topotecan Hydrochloride API manufacturers, exporters, distributors and traders.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Hycamtin, NSC 609699, Topotecan Hydrochloride Drug Master File in Japan (Hycamtin, NSC 609699, Topotecan Hydrochloride JDMF) empowers Hycamtin, NSC 609699, Topotecan Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Hycamtin, NSC 609699, Topotecan Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Hycamtin, NSC 609699, Topotecan Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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