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List of Drug Master Files (JDMF) for Temozolamide Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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

02 FORMOSA LABORATORIES, INC. (1)

03 Shilpa Pharma Lifesciences Limited (1)

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01 Temozolomide (3)

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01 India (1)

02 Luxembourg (1)

03 Taiwan (1)

URL Supplier Web Content
228MF10143
36 Hoping Street, Louchu, Taoyuan 3...
2020-04-27
2016-08-03
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URL Supplier Web Content
228MF10125
Shilpa House, #12-6-214/A1, Hyderab...
2023-02-15
2016-07-12
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Looking for 85622-93-1 / Temozolomide API manufacturers, exporters & distributors?

Temozolomide manufacturers, exporters & distributors 1

90

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.

Temozolamide Manufacturers

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

Temozolamide Suppliers

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

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

Temozolamide JDMF

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 Temozolamide Drug Master File in Japan (Temozolamide JDMF) empowers Temozolamide 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 Temozolamide JDMF during the approval evaluation for pharmaceutical products. At the time of Temozolamide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Temozolamide suppliers with JDMF on PharmaCompass.

Temozolamide Manufacturers | Traders | Suppliers

Temozolamide Manufacturers, Traders, Suppliers 1
42

We have 3 companies offering Temozolamide

Get in contact with the supplier of your choice:

  1. Fareva
  2. Formosa Laboratories
  3. 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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