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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

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NDC API

NDC API

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API REF. PRICE (USD/KG)

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MARKET PLACE

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FDF

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FDA (Orange Book)

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Europe

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EDQM

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USP

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GLOBAL SALES INFORMATION

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Chemistry

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Also known as: Orgotein, bovine, Orgotein [inn], Orgotein [usan], Orgotein [mart.], Orgotein [who-dd], Orgotein [green book]
Molecular Formula
Cu4Zn4+16
Molecular Weight
515.7  g/mol
InChI Key
TUGDLVFMIQZYPA-UHFFFAOYSA-N

Orgotein
1 2D Structure

Orgotein

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
tetracopper;tetrazinc
2.1.2 InChI
InChI=1S/4Cu.4Zn/q8*+2
2.1.3 InChI Key
TUGDLVFMIQZYPA-UHFFFAOYSA-N
2.1.4 Canonical SMILES
[Cu+2].[Cu+2].[Cu+2].[Cu+2].[Zn+2].[Zn+2].[Zn+2].[Zn+2]
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Bovine Copper-zinc Superoxide Dismutase

2. Ontose

3. Ontosein

4. Ormetein

5. Palosein

6. Peroxinorm

7. Superoxide Dismutase (bovine)

2.2.2 Depositor-Supplied Synonyms

1. Orgotein, Bovine

2. Orgotein [inn]

3. Orgotein [usan]

4. Orgotein [mart.]

5. Orgotein [who-dd]

6. Orgotein [green Book]

7. Ontosein

8. Ormetein

9. Palosein

10. Superoxide Dismutase (bovine)

11. Copper-zinc Superoxide Dismutase

12. Superoxide Dismutase, Bovine (cu-zn)

13. Orgotein [usan:inn]

14. Unii-pke82w49v1

15. Pke82w49v1

16. Bovine Copper-zinc Superoxide Dismutase

17. 1569268-91-2

2.3 Create Date
2014-03-02
3 Chemical and Physical Properties
Molecular Weight 515.7 g/mol
Molecular Formula Cu4Zn4+16
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count0
Rotatable Bond Count0
Exact Mass515.42574 g/mol
Monoisotopic Mass507.43496 g/mol
Topological Polar Surface Area0 Ų
Heavy Atom Count8
Formal Charge16
Complexity0
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count8
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Anti-Inflammatory Agents, Non-Steroidal

Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)


4.2 ATC Code

M - Musculo-skeletal system

M01 - Antiinflammatory and antirheumatic products

M01A - Antiinflammatory and antirheumatic products, non-steroids

M01AX - Other antiinflammatory and antirheumatic agents, non-steroids

M01AX14 - Orgotein


Market Place

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ABOUT THIS PAGE

Orgotein Manufacturers

A Orgotein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orgotein, including repackagers and relabelers. The FDA regulates Orgotein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orgotein API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Orgotein Suppliers

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

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

Orgotein USDMF

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

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

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

Orgotein CEP

A Orgotein CEP of the European Pharmacopoeia monograph is often referred to as a Orgotein Certificate of Suitability (COS). The purpose of a Orgotein CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Orgotein EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Orgotein to their clients by showing that a Orgotein CEP has been issued for it. The manufacturer submits a Orgotein CEP (COS) as part of the market authorization procedure, and it takes on the role of a Orgotein CEP holder for the record. Additionally, the data presented in the Orgotein CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Orgotein DMF.

A Orgotein CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Orgotein CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Orgotein suppliers with CEP (COS) on PharmaCompass.

Orgotein GMP

Orgotein Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Orgotein GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Orgotein GMP manufacturer or Orgotein GMP API supplier for your needs.

Orgotein CoA

A Orgotein CoA (Certificate of Analysis) is a formal document that attests to Orgotein's compliance with Orgotein specifications and serves as a tool for batch-level quality control.

Orgotein CoA mostly includes findings from lab analyses of a specific batch. For each Orgotein CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Orgotein may be tested according to a variety of international standards, such as European Pharmacopoeia (Orgotein EP), Orgotein JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Orgotein USP).

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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