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List of Korea Drug Master Files (KDMF) for Topotecan Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Korea United Pharmaceutical Co., Ltd.
2016-03-02
20120703-207-I-40-01(1)
ScinoPharm Taiwan, Ltd.
Taiwan
No. 1, Nan-Ke 8th Road, T...
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Samo Pharmaceutical Co., Ltd.
2018-02-02
20120703-207-I-40-01(A)
ScinoPharm Taiwan. Ltd
Taiwan
No1, Nan-Ke 8th Road, Sha...
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Alvogen Korea Co., Ltd.
2012-07-03
20120703-207-I-40-01
ScinoPharm Taiwan, Ltd.
Taiwan
No.1 Nan-Ke 8th Road Shan...
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Samil Pharmaceutical Co., Ltd.
2013-03-07
20130307-207-I-129-03
Thermo Fisher Scientific ...
Ireland
Currabinny, Carrigaline, ...
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  • SOLUTION;INTRAVENOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
  • INJECTABLE;INJECTION - EQ 4MG BASE/VIAL
  • CAPSULE;ORAL - EQ 0.25MG BASE
  • CAPSULE;ORAL - EQ 1MG BASE

Looking for 119413-54-6 / Topotecan Hydrochloride API manufacturers, exporters & distributors?

Topotecan Hydrochloride manufacturers, exporters & distributors 1

22

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.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Topotecan Hydrochloride manufacturer or Topotecan Hydrochloride supplier.

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.

API | Excipient name

Topotecan Hydrochloride

Synonyms

119413-54-6, Topotecan hcl, Hycamtin, Nogitecan hydrochloride, Topotecan (hydrochloride), Topotecan monohydrochloride

Cas Number

119413-54-6

Unique Ingredient Identifier (UNII)

956S425ZCY

About Topotecan Hydrochloride

An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.

Topotecan Manufacturers

A Topotecan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Topotecan, including repackagers and relabelers. The FDA regulates Topotecan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Topotecan 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Topotecan Suppliers

A Topotecan supplier is an individual or a company that provides Topotecan active pharmaceutical ingredient (API) or Topotecan finished formulations upon request. The Topotecan suppliers may include Topotecan API manufacturers, exporters, distributors and traders.

click here to find a list of Topotecan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Topotecan KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Topotecan Drug Master File in Korea (Topotecan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Topotecan. The MFDS reviews the Topotecan KDMF as part of the drug registration process and uses the information provided in the Topotecan KDMF to evaluate the safety and efficacy of the drug.

After submitting a Topotecan 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 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Topotecan suppliers with KDMF on PharmaCompass.

Topotecan Manufacturers | Traders | Suppliers

Topotecan Manufacturers, Traders, Suppliers 1
44

We have 2 companies offering Topotecan

Get in contact with the supplier of your choice:

  1. ScinoPharm Taiwan, Ltd
  2. Thermo Fisher Scientific
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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