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

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01 Synthelabo Tanabe Chimie (2)

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01 KETOISOLEUCINE L-ORNITHINE SALT (1)

02 PRECLINICAL ANIMAL STUDIES FOR TRIPTOSINE (1)

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01 France (2)

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01 Inactive (2)

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01 Blank (2)

URL Supplier Web Content
9816
Inactive
1992-08-14
N/A
II
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URL Supplier Web Content
5924
Inactive
1985-07-05
N/A
II
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Looking for 3184-13-2 / Ornithine API manufacturers, exporters & distributors?

Ornithine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ornithine

Synonyms

70-26-8, (s)-2,5-diaminopentanoic acid, (s)-ornithine, (s)-2,5-diaminovaleric acid, Ornithine [inn], (2s)-2,5-diaminopentanoic acid

Cas Number

3184-13-2

Unique Ingredient Identifier (UNII)

E524N2IXA3

About Ornithine

An amino acid produced in the urea cycle by the splitting off of urea from arginine.

Ornithine Manufacturers

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

Ornithine Suppliers

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

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

Ornithine USDMF

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

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

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

Ornithine Manufacturers | Traders | Suppliers

Ornithine Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Ornithine

Get in contact with the supplier of your choice:

  1. Synthelabo Tanabe Chimie
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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