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

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01 Excella GmbH & Co. K.G. (1)

02 Sun Pharmaceutical Industries Ltd (1)

03 Ampac Fine Chemicals (1)

04 Formosa Laboratories, Inc. Louchu Plant@[Starting Material Manufacturing Plant]Azide Chemical Co., Ltd._x000D_ _x000D_ (1)

05 Shilpa Medicare Limited (1)

06 Shilpa Pharma Lifesciences Limited (2)

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01 Alvogen Korea Co., Ltd. (1)

02 Hwail Pharmaceutical Co., Ltd. (1)

03 MSD Korea Co., Ltd. (1)

04 Masung LS Co., Ltd. (1)

05 Samo Pharmaceutical Co., Ltd. (2)

06 Shinpoong Pharmaceutical Co., Ltd. (1)

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01 temozolomide (7)

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01 Germany (1)

02 India (4)

03 Taiwan (1)

04 U.S.A (1)

URL Supplier Web Content
Samo Pharmaceutical Co., Ltd.
2022-09-28
Wed207-56-ND
Excella GmbH & Co. K.G.
Germany
Nurnberger Strasse 12, 90...
Fareva Company Banner

EMWA 2024

Not Confirmed

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URL Supplier Web Content
Samo Pharmaceutical Co., Ltd.
2016-07-13
Wed207-27-ND
Sun Pharmaceutical Indust...
India
A-7/A-8, MIDC, Industrial...
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MSD Korea Co., Ltd.
2005-03-16
406-1-ND
Ampac Fine Chemicals
U.S.A
Highway 50 & Hazel Avenue...
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Alvogen Korea Co., Ltd.
2015-08-11
Number 1367-1-ND
Formosa Laboratories, Inc...
Taiwan
No. 36 & 36-1 Hoping Stre...
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Hwail Pharmaceutical Co., Ltd.
2013-07-26
1414-4-ND(2)
Shilpa Pharma Lifescience...
India
Plot No.: 1A & 1A'P', 1B,...
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Masung LS Co., Ltd.
2013-05-15
1414-4-ND(A)
Shilpa Pharma Lifescience...
India
Plot No.: 1A & 1A'P', 1B,...
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Shinpoong Pharmaceutical Co., Ltd.
2013-01-15
1414-4-ND
Shilpa Medicare Limited
India
Deosugur Industrial area,...
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Looking for 85622-93-1 / Temozolomide API manufacturers, exporters & distributors?

Temozolomide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Temozolomide

Synonyms

85622-93-1, Methazolastone, Temodar, Temodal, Temozolamide, 3-methyl-4-oxo-3,4-dihydroimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide

Cas Number

85622-93-1

Unique Ingredient Identifier (UNII)

YF1K15M17Y

About Temozolomide

A dacarbazine derivative that is used as an alkylating antineoplastic agent for the treatment of MALIGNANT GLIOMA and MALIGNANT MELANOMA.

Temozolomide Manufacturers

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

Temozolomide Suppliers

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

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

Temozolomide KDMF

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

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

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

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

Temozolomide Manufacturers | Traders | Suppliers

Temozolomide Manufacturers, Traders, Suppliers 1
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We have 5 companies offering Temozolomide

Get in contact with the supplier of your choice:

  1. Excella GmbH
  2. Sun Pharmaceutical Industries Limited
  3. AMPAC Fine Chemicals
  4. Formosa Laboratories
  5. Shilpa Medicare
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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