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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

API SUPPLIERS

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Metrochem API Private Limited

India

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Metrochem

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Ami Lifesciences Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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HRV Global Life Sciences

India

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Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Tagoor Laboratories

India

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Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

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05

Shanghai Neutan Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Breast Cancer
Not Confirmed
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Shanghai Neutan Pharmaceutical

China

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Lee Pharma

India

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Lee Pharma

India

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Lee Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Breast Cancer
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Lee Pharma

India

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Lee Pharma

India

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Breast Cancer
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Lee Pharma

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Lee Pharma

India

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Lee Pharma

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Lee Pharma

India

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Lee Pharma

India

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USDMF

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39342

Submission : 2023-12-29

Status : Active

Type : II

AMI Lifesciences

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Lee Pharma Ltd

India

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Excipient World
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Excipient World
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DMF Review : N/A

Rev. Date :

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DMF Number : 38908

Submission : 2023-09-20

Status : Active

Type : II

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Listed Suppliers

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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Mirogabalin Besylate

About the Company : 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 gro...

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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Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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Mirogabalin Besylate

About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...

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.
AMI Lifesciences

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Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Mirogabalin Besylate

About the Company : HRV Global 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 Global 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 Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences

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Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

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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.
Tagoor Laboratories

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Mirogabalin Besilate

About the Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to G...

Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to GMP standards. We take great pride in producing top-notch intermediates through our fully backward-integrated process. Aptra Synthesis Private Limited (ASPL) stands as one of the rapidly emerging manufacturers of Active Pharmaceutical Ingredients (APIs), Pellets (Semi-finished Formulations), and Intermediates.
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Mirogabalin Besylate

About the Company : Ceyone Life Sciences specializes in providing research-oriented chemistry services and manufacturing niche chemicals, intermediates, and APIs. The company is focused on offering co...

Ceyone Life Sciences specializes in providing research-oriented chemistry services and manufacturing niche chemicals, intermediates, and APIs. The company is focused on offering comprehensive R&D services to meet the global needs of clients while ensuring environmental sustainability and compliance with international regulatory standards. Their goal is to be a leading provider of innovative solutions in the field of specialty chemicals and pharmaceuticals.
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Honour Lab

India
China Battery Fair
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Honour Lab

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Mirogabalin Besylate

About the Company : Honour is a leading global Contract Development and Manufacturing Organization (CDMO) as well as a manufacturer of specialty chemicals and ingredients, operating six facilities tha...

Honour is a leading global Contract Development and Manufacturing Organization (CDMO) as well as a manufacturer of specialty chemicals and ingredients, operating six facilities that adhere to international standards of safety and quality. Through our offerings, Honour Synthesis and Honour Specialty, we are committed to fostering partnerships and exploring new possibilities. Our team of over 2,000 professionals delivers exceptional service to our pharmaceutical and biotechnology partners by providing practical solutions.
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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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Mirogabalin Besylate

About the Company : Synthimed Labs is a leading API manufacturer recognized for its high-quality and diverse range of Active Pharmaceutical Ingredients (APIs). Their product portfolio includes a wide ...

Synthimed Labs is a leading API manufacturer recognized for its high-quality and diverse range of Active Pharmaceutical Ingredients (APIs). Their product portfolio includes a wide array of APIs developed through advanced research and rigorous quality control processes.
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China Battery Fair
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Mirogabalin Besilate

About the Company : Established in 1999, Hankang Pharmaceutical Group stands as a prominent CRO-CDMO integrated service enterprise in China. Focused on generic drugs while venturing into innovative on...

Established in 1999, Hankang Pharmaceutical Group stands as a prominent CRO-CDMO integrated service enterprise in China. Focused on generic drugs while venturing into innovative ones, the group is dedicated to offering comprehensive solutions to the industry. Presently, Hankang has crafted over 200 varieties for 600+ domestic and international companies, serving 10+ innovative drugs. It has successfully developed more than 10 initial generic drugs, with over 20 varieties endorsed by the top three domestic companies and 30 exceeding a 100 million output value.
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API Reference Price

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18-May-2023
05-Feb-2025
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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.

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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 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 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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