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Also known as: 1138245-21-2, Mirogabalin besilate, Mirogabalin besylate [usan], 01f4frp8yl, 2-[(1r,5s,6s)-6-(aminomethyl)-3-ethyl-6-bicyclo[3.2.0]hept-3-enyl]acetic acid;benzenesulfonic acid, Mirogabalin besilate (jan)
Molecular Formula
C18H25NO5S
Molecular Weight
367.5  g/mol
InChI Key
OKJXJRVWXYRSAN-TXULWXBWSA-N
FDA UNII
01F4FRP8YL

Mirogabalin Besylate
1 2D Structure

Mirogabalin Besylate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[(1R,5S,6S)-6-(aminomethyl)-3-ethyl-6-bicyclo[3.2.0]hept-3-enyl]acetic acid;benzenesulfonic acid
2.1.2 InChI
InChI=1S/C12H19NO2.C6H6O3S/c1-2-8-3-9-5-12(7-13,6-11(14)15)10(9)4-8;7-10(8,9)6-4-2-1-3-5-6/h4,9-10H,2-3,5-7,13H2,1H3,(H,14,15);1-5H,(H,7,8,9)/t9-,10-,12-;/m1./s1
2.1.3 InChI Key
OKJXJRVWXYRSAN-TXULWXBWSA-N
2.1.4 Canonical SMILES
CCC1=CC2C(C1)CC2(CC(=O)O)CN.C1=CC=C(C=C1)S(=O)(=O)O
2.1.5 Isomeric SMILES
CCC1=C[C@@H]2[C@H](C1)C[C@@]2(CC(=O)O)CN.C1=CC=C(C=C1)S(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
01F4FRP8YL
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 1138245-21-2

2. Mirogabalin Besilate

3. Mirogabalin Besylate [usan]

4. 01f4frp8yl

5. 2-[(1r,5s,6s)-6-(aminomethyl)-3-ethyl-6-bicyclo[3.2.0]hept-3-enyl]acetic Acid;benzenesulfonic Acid

6. Mirogabalin Besilate (jan)

7. Mirogabalin Besylate (usan)

8. 2-((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl)acetic Acid Compound With Benzenesulfonic Acid (1:1)

9. Bicyclo(3.2.0)hept-3-ene-6-acetic Acid, 6-(aminomethyl)-3-ethyl-, (1r,5s,6s)-, Benzenesulfonate (1:1)

10. Mirogabalin Besilate [jan]

11. Unii-01f4frp8yl

12. Mirogabalin Besilate [who-dd]

13. Schembl1883872

14. Chembl3545257

15. Amy16760

16. Ex-a2817

17. Mfcd31631215

18. Ac-30336

19. Hy-108006

20. Cs-0027136

21. D10790

22. A901402

23. 2-((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl)acetic Acid Besylate

24. 2-((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl)aceticacidbesylate

25. ((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo(3.2.0)hept-3-en-6-yl)acetic Acid Monobenzenesulfonate

26. [(1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl]acetic Acid Benzenesulfonate;

2.4 Create Date
2014-10-20
3 Chemical and Physical Properties
Molecular Weight 367.5 g/mol
Molecular Formula C18H25NO5S
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count6
Rotatable Bond Count5
Exact Mass367.14534407 g/mol
Monoisotopic Mass367.14534407 g/mol
Topological Polar Surface Area126 Ų
Heavy Atom Count25
Formal Charge0
Complexity494
Isotope Atom Count0
Defined Atom Stereocenter Count3
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

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MAPO-GU - 04034 Seoul, , Korea, Republic of Korea, Republic of","customerAddress":"H NO 5 1 3B SANGEETHNAGAR COLONY,K"}]
03-May-2023
25-Apr-2025
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FCE Pharma
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Mirogabalin

Brand Name : Gabalihochs

Dosage Form : Orally Disintegrated T...

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Egypt

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01

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

Mirogabalin

Dosage : Orally Disintegrated T...

Dosage Strength : 15MG

Brand Name : Gabalihochs

Approval Date :

Application Number :

Registration Country : Egypt

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ABOUT THIS PAGE

Looking for 1138245-21-2 / Mirogabalin Besilate API manufacturers, exporters & distributors?

Mirogabalin Besilate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Mirogabalin Besilate

Synonyms

1138245-21-2, Mirogabalin besylate [usan], 01f4frp8yl, 2-[(1r,5s,6s)-6-(aminomethyl)-3-ethyl-6-bicyclo[3.2.0]hept-3-enyl]acetic acid;benzenesulfonic acid, Mirogabalin besilate (jan), Mirogabalin besylate (usan)

Cas Number

1138245-21-2

Unique Ingredient Identifier (UNII)

01F4FRP8YL

Mirogabalin Manufacturers

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

Mirogabalin Suppliers

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

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

Mirogabalin USDMF

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

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

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

Mirogabalin KDMF

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

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

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

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

Mirogabalin WC

A Mirogabalin written confirmation (Mirogabalin WC) is an official document issued by a regulatory agency to a Mirogabalin manufacturer, verifying that the manufacturing facility of a Mirogabalin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mirogabalin APIs or Mirogabalin finished pharmaceutical products to another nation, regulatory agencies frequently require a Mirogabalin WC (written confirmation) as part of the regulatory process.

click here to find a list of Mirogabalin suppliers with Written Confirmation (WC) on PharmaCompass.

Mirogabalin NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Mirogabalin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Mirogabalin API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Mirogabalin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Mirogabalin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mirogabalin NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Mirogabalin suppliers with NDC on PharmaCompass.

Mirogabalin GMP

Mirogabalin 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 Mirogabalin 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 Mirogabalin GMP manufacturer or Mirogabalin GMP API supplier for your needs.

Mirogabalin CoA

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

Mirogabalin CoA mostly includes findings from lab analyses of a specific batch. For each Mirogabalin 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.

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