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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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Ami Lifesciences Private Limited

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Honour Lab Limited

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Submission : 2025-02-12

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Mirogabalin Besylate IH

Date of Issue : 2022-06-15

Valid Till : 2025-07-28

Written Confirmation Number : WC-0186

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Mirogabalin besylate

Registrant Name : Iksoo Pharmaceutical Co., Ltd.

Registration Date : 2025-03-11

Registration Number : Su69-20-ND

Manufacturer Name : Ami Lifesciences Pvt. Ltd.

Manufacturer Address : Block No. 82/B, ECP Road, At & Post: Karakhadi-391450, Taluka: Padra, District : Vado...

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Mirogabalin besylate

Registrant Name : Lee Sung International Co., Ltd.

Registration Date : 2024-06-14

Registration Number : Thu21-27-ND

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Mirogabalin besylate

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2025-04-02

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Mirogabalin besylate

Registrant Name : Pharmawon Co., Ltd.

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Mirogabalin besylate

Registrant Name : Samjin Pharmaceutical Co., Ltd.

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Mirogabalin besylate

Registrant Name : Lihu Healthcare Co., Ltd.

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Mirogabalin besylate

Registrant Name : Pharmapia Co., Ltd.

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Mirogabalin besylate

Registrant Name : Grace Farm

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Mirogabalin besylate

Registrant Name : Sungwoo Chemical Co., Ltd.

Registration Date : 2025-02-28

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Mirogabalin besylate

Registrant Name : Korea Daiichi Sankyo Co., Ltd.

Registration Date : 2020-01-23

Registration Number : Su256-4-ND

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Manufacturer Address : 477, Takada, Odawara, Kanagawa, Japan

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MIROGABALIN

NDC Package Code : 81999-0015

Start Marketing Date : 2025-01-20

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
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Mirogabalin Besylate

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Lee Pharma Ltd, established in 1997, is a research-driven pharmaceutical company focused on developing and commercializing high-quality APIs, intermediates, and finished formulations. Our world-class manufacturing facilities are certified with USFDA, EU GMP, WHO GMP. We are committed to excellence & are present across more than 50 countries. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
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Mirogabalin Besylate

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Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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Mirogabalin Besylate

About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Pharma effectively promote projects and products. HRV Pharma represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Pharma has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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Mirogabalin

About the Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-g...

Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-growth therapeutic areas, with an emphasis on affordability, quality and timely delivery. It also provides end-to-end CDMO services. Headquartered in Hyderabad, Tagoor Labs is a fast-growing Indian pharma company that serves both branded and generic companies worldwide. The company’s organizational function includes R&D, supply chain, manufacturing, quality testing, quality assurance, regulatory affairs, marketing & sales, and packaging & warehousing departments.
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Mirogabalin Besylate

About the Company : Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standar...

Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standards, we are committed to delivering excellence with innovative, holistic solutions to clients across the globe by leveraging our expertise in chemistry. Operating through our two core verticals - Honour Synthesis and Honour Specialty, we embrace the science of partnership and possibilities. Our team of over 2,500 professionals collaborates closely with pharmaceutical, biotechnology, and specialty industries worldwide to develop practical, scalable solutions.
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Mirogabalin

About the Company : Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing of generic APIs and ...

Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing of generic APIs and advanced intermediates, and also offer high-quality CDMO/CMO services for small-molecule drugs. Qingmu has been inspected and approved by global regulatory authorities such as the US FDA, Korea MFDS, and China NMPA, and has earned client approvals across the U.S., Europe, Japan, and China. With strong technical capabilities and a commitment to international quality standards, we support customers from early development through to commercial supply.
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Mirogabalin Besilate

About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...

Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients and their intermediates, electronic chemical materials and intermediates, large-scale production, sales and services, and provide customized synthetic services according to customer requirements. Sjar-Tech locates in Beijing Economic and Technological Development Zone, has its own R&D and development laboratory. Sjar-Tech has set up a R&D team with rich experience and strong technical strength, most of the practitioners have more than ten years' experience.
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Mirogabalin Besylate

About the Company : Flax Laboratories was established by a group of young and experienced professionals with the specific objective to develop and produce complex, small volume, technology driven bulk...

Flax Laboratories was established by a group of young and experienced professionals with the specific objective to develop and produce complex, small volume, technology driven bulk drugs and intermediates at competitive price. Our objective of providing the critical India advantage to both the innovator and generic pharmaceutical players in both domestic and international markets including the regulated markets.
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Mirogabalin Besilate

About the Company : Hope Chem is dedicated to manufacturing, marketing, and CMO service of Active Pharmaceutical Ingredients (APIs), Intermediates, and Specialty Chemicals since the year 2010. Current...

Hope Chem is dedicated to manufacturing, marketing, and CMO service of Active Pharmaceutical Ingredients (APIs), Intermediates, and Specialty Chemicals since the year 2010. Currently, they have exclusive partnerships with multiple, state-of-the-art and GMP-compliant manufacturers in China and abroad to service our esteemed partners for competitive, long-term & stable supplies. The main products are APIs and intermediates of antiviral drug substances and anti-inflammatory, analgesic, and non-steroidal pharmaceuticals.
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OF","quantity":"7.00","actualQuantity":"7","unit":"KGS","unitRateFc":"12000","totalValueFC":"82897.8","currency":"USD","unitRateINR":1017575.8571428572,"date":"17-Jun-2025","totalValueINR":"7123031","totalValueInUsd":"82897.8","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2780793","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SYNO.257 258\/1, DNO.11-6\/56,, VILLAGE BALANGAR POST HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750703400,"product":"MIROGABALIN BESYLATE (IN-HOUSE) (EXPORTINVOICE NO : 6125010138 DT :17.06.2025)","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"LEE PHARMA LTD","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"HOCHSTER PHARMACEUTICAL 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OF","quantity":"8.00","actualQuantity":"8","unit":"KGS","unitRateFc":"11500","totalValueFC":"90204.6","currency":"USD","unitRateINR":970442.875,"date":"08-Jul-2025","totalValueINR":"7763543","totalValueInUsd":"90204.6","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"3378226","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H NO 5 1 3B SANGEETHNAGAR COLONY,K, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721845800,"product":"MIROGABALIN BESYLATE","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"ZENJI PHARMACEUTICALS SU ZHOU LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"1.30","actualQuantity":"1.3","unit":"KGS","unitRateFc":"3878","totalValueFC":"5099.2","currency":"USD","unitRateINR":"327884.9","date":"25-Jul-2024","totalValueINR":"426250.37","totalValueInUsd":"5099.2","indian_port":"Hyderabad Air","hs_no":"29142990","bill_no":"4684027","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"122 XUQING ROAD, XUGUAN TOWN, SUZHOU, JIANGSU, CHINA, 215151 CHINASDNF China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739557800,"product":"MIROGABALIN BESYLATE(RE IMPORT -SB NO:5825298 DT:22.11.2024) ORGANICCHEMICAL","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"JAZEERA PHARMACEUTICAL INDUSTRIES","supplierCountry":"SAUDI 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03-May-2023
08-Jul-2025
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Drugs in Development

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01

World Drug Safety EU
Not Confirmed
World Drug Safety EU
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 26, 2025

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Details:

Tarlige® (mirogabalin besilate), is an analgesic works by inhibiting the excessive release of pain-related neurotransmitters in presynaptic nerve terminal, ® was approved for the indication of “peripheral neuropathic pain” in Japan.


Lead Product(s): Mirogabalin Besylate,Inapplicable

Therapeutic Area: Neurology Brand Name: Tarlige

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 28, 2022

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02

World Drug Safety EU
Not Confirmed
World Drug Safety EU
Not Confirmed

Details : Tarlige® (mirogabalin besilate), is an analgesic works by inhibiting the excessive release of pain-related neurotransmitters in presynaptic nerve terminal, ® was approved for the indication of “peripheral neuropathic pain” in Japan.

Product Name : Tarlige

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 28, 2022

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03

World Drug Safety EU
Not Confirmed
World Drug Safety EU
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 19, 2019

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Details:

Undisclosed


Lead Product(s): Mirogabalin Besylate,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 03, 2019

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04

World Drug Safety EU
Not Confirmed
World Drug Safety EU
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 03, 2019

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INTERMEDIATE SUPPLIERS

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01

ChemOutsourcing
Not Confirmed
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ChemOutsourcing
Not Confirmed
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CAS Number : 1235479-61-4

End Use API : Mirogabalin Besylate

About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...

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02

ChemOutsourcing
Not Confirmed
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ChemOutsourcing
Not Confirmed
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CAS Number : 1235479-61-4

End Use API : Mirogabalin Besylate

About The Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Activ...

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ABOUT THIS PAGE

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

Mirogabalin Besylate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Mirogabalin Besylate

Synonyms

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)

Cas Number

1138245-21-2

Unique Ingredient Identifier (UNII)

01F4FRP8YL

Mirogabalin Besylate Manufacturers

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

Mirogabalin Besylate Suppliers

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

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

Mirogabalin Besylate USDMF

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

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

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

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

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

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

Mirogabalin Besylate WC

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

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

Mirogabalin Besylate 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 Besylate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Mirogabalin Besylate 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 Besylate 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 Besylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mirogabalin Besylate NDC to their finished compounded human drug products, they may choose to do so.

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

Mirogabalin Besylate GMP

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

Mirogabalin Besylate CoA

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

Mirogabalin Besylate CoA mostly includes findings from lab analyses of a specific batch. For each Mirogabalin Besylate 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 Besylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Mirogabalin Besylate EP), Mirogabalin Besylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mirogabalin Besylate 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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