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List of Drug Master Files (KDMF) for Thiotepa Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Heraeus Deutschland GmbH & Co. K.G. (1)

02 MSN Laboratories Private Limited (1)

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01 Ace Pharma Co., Ltd. (1)

02 Dongin Pharmaceutical Co., Ltd. (1)

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01 Thiotepa (2)

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01 Germany (1)

02 India (1)

URL Supplier Web Content
Dongin Pharmaceutical Co., Ltd.
2022-04-14
20220414-210-J-1265
Heraeus Deutschland GmbH ...
Germany
Heraeusstraße 12-14 621,...
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URL Supplier Web Content
Ace Pharma Co., Ltd.
2023-02-17
20230217-210-J-1447
MSN Laboratories Private ...
India
(Unit-II), Sy.No.50, Kard...
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Looking for 52-24-4 / Thiotepa API manufacturers, exporters & distributors?

Thiotepa manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Thiotepa 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 Thiotepa manufacturer or Thiotepa supplier for your needs.

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

PharmaCompass also assists you with knowing the Thiotepa API Price utilized in the formulation of products. Thiotepa API Price is not always fixed or binding as the Thiotepa Price is obtained through a variety of data sources. The Thiotepa Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Thiotepa

Synonyms

Thio-tepa, 52-24-4, Triethylenethiophosphoramide, Thioplex, Thiophosphamide, Tiofosfamid

Cas Number

52-24-4

Unique Ingredient Identifier (UNII)

905Z5W3GKH

About Thiotepa

A very toxic alkylating antineoplastic agent also used as an insect sterilant. It causes skin, gastrointestinal, CNS, and bone marrow damage. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), thiotepa may reasonably be anticipated to be a carcinogen (Merck Index, 11th ed).

Thiotepa Manufacturers

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

Thiotepa Suppliers

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

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

Thiotepa KDMF

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

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

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

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

Thiotepa Manufacturers | Traders | Suppliers

Thiotepa Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Thiotepa

Get in contact with the supplier of your choice:

  1. Heraeus Holding
  2. MSN Laboratories
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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