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List of Drug Master Files (DMF) of Nitisinone Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Biophore India Pharmaceuticals Pvt Ltd (1)

02 Nuray Chemicals Private Limited (1)

03 Dipharma SA (1)

04 Saurav Chemicals (1)

05 Teva API (1)

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01 NITISINONE (5)

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01 India (3)

02 Israel (1)

03 Switzerland (1)

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01 Active (5)

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01 Complete (4)

02 Blank (1)

31250
Active
2017-01-02
Complete
2017-02-01
2016-12-26
II
Nuray Chemicals Company Banner

Iran Expo

Not Confirmed

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URL Supplier Web Content
36026
Active
2021-07-31
Complete
2021-09-21
2021-08-02
II
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URL Supplier Web Content
35810
Active
2021-03-31
N/A
II
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URL Supplier Web Content
30680
Active
2016-10-19
Complete
2016-12-22
2016-10-11
II
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Looking for 104206-65-7 / Nitisinone API manufacturers, exporters & distributors?

Nitisinone manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Nitisinone

Synonyms

104206-65-7, Orfadin, 2-(2-nitro-4-(trifluoromethyl)benzoyl)cyclohexane-1,3-dione, Nitisone, Ntbc, 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione

Cas Number

104206-65-7

Unique Ingredient Identifier (UNII)

K5BN214699

About Nitisinone

Nitisinone is a synthetic reversible inhibitor of 4-hydroxyphenylpyruvate dioxygenase. It is used in the treatment of hereditary tyrosinemia type 1. It is sold under the brand name Orfadin.

Nitisinone Manufacturers

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

Nitisinone Suppliers

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

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

Nitisinone USDMF

A Nitisinone DMF (Drug Master File) is a document detailing the whole manufacturing process of Nitisinone active pharmaceutical ingredient (API) in detail. Different forms of Nitisinone DMFs exist exist since differing nations have different regulations, such as Nitisinone USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Nitisinone DMF submitted to regulatory agencies in the US is known as a USDMF. Nitisinone USDMF includes data on Nitisinone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nitisinone USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Nitisinone suppliers with USDMF on PharmaCompass.

Nitisinone Manufacturers | Traders | Suppliers

Nitisinone Manufacturers, Traders, Suppliers 1
52

We have 5 companies offering Nitisinone

Get in contact with the supplier of your choice:

  1. Biophore India Pharmaceuticals Pvt Ltd
  2. Nuray Chemicals Private Limited
  3. Dipharma SA
  4. Saurav Chemicals
  5. Teva API
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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