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ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: 254740-64-2, Sparsentan (re-021), Re-021, Sparsentan [usan], Ps433540, Ps-433540
Molecular Formula
C32H40N4O5S
Molecular Weight
592.8  g/mol
InChI Key
WRFHGDPIDHPWIQ-UHFFFAOYSA-N
FDA UNII
9242RO5URM

Sparsentan
Sparsentan has been used in trials studying the treatment of Focal Segmental Glomerulosclerosis. Sparsentan is the first and only dual-acting angiotensin and endothelin receptor antagonist (DARA) in development.
1 2D Structure

Sparsentan

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[4-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-2-(ethoxymethyl)phenyl]-N-(4,5-dimethyl-1,2-oxazol-3-yl)benzenesulfonamide
2.1.2 InChI
InChI=1S/C32H40N4O5S/c1-5-7-14-29-33-32(17-10-11-18-32)31(37)36(29)20-24-15-16-26(25(19-24)21-40-6-2)27-12-8-9-13-28(27)42(38,39)35-30-22(3)23(4)41-34-30/h8-9,12-13,15-16,19H,5-7,10-11,14,17-18,20-21H2,1-4H3,(H,34,35)
2.1.3 InChI Key
WRFHGDPIDHPWIQ-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCCCC1=NC2(CCCC2)C(=O)N1CC3=CC(=C(C=C3)C4=CC=CC=C4S(=O)(=O)NC5=NOC(=C5C)C)COCC
2.2 Other Identifiers
2.2.1 UNII
9242RO5URM
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (1,1'-biphenyl)-2-sulfonamide, 4'-((2-butyl-4-oxo-1,3-diazaspiro(4.4)non-1-en-3-yl)methyl)-n-(4,5-dimethyl-3-isoxazolyl)-2'-(ethoxymethyl)-

2. 4'-((2-butyl-4-oxo-1,3-diazaspiro(4.4)non-1-en-3-yl)methyl)-n-(4,5-dimethyl-1,2-oxazol-3-yl)-2'-(ethoxymethyl)-2-biphenylsulfonamide

3. 4'-((2-butyl-4-oxo-1,3-diazaspiro(4.4)non-1-en-3-yl)methyl)-n-(4,5-dimethyl-1,2-oxazol-3-yl)-2'-(ethoxymethyl)biphenyl-2-sulfonamide

4. Re-021

2.3.2 Depositor-Supplied Synonyms

1. 254740-64-2

2. Sparsentan (re-021)

3. Re-021

4. Sparsentan [usan]

5. Ps433540

6. Ps-433540

7. 9242ro5urm

8. Chembl539423

9. 2-[4-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-2-(ethoxymethyl)phenyl]-n-(4,5-dimethyl-1,2-oxazol-3-yl)benzenesulfonamide

10. 4'-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl)-n-(4,5-dimethylisoxazol-3-yl)-2'-(ethoxymethyl)-[1,1'-biphenyl]-2-sulfonamide

11. Retrophin

12. (1,1'-biphenyl)-2-sulfonamide, 4'-((2-butyl-4-oxo-1,3-diazaspiro(4.4)non-1-en-3-yl)methyl)-n-(4,5-dimethyl-3-isoxazolyl)-2'-(ethoxymethyl)-

13. [1,1'-biphenyl]-2-sulfonamide, 4'-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-n-(4,5-dimethyl-3-isoxazolyl)-2'-(ethoxymethyl)-

14. Unii-9242ro5urm

15. Dara

16. Compound 7 [pmid 15634011]

17. Dara-a

18. Ps 33540

19. Sparsentan [inn]

20. Sparsentan (usan/inn)

21. Sparsentan(ps433540)

22. Sparsentan [who-dd]

23. Schembl535109

24. Gtpl8448

25. Amy38147

26. Bcp23969

27. Ex-a3048

28. Bdbm50175523

29. S6665

30. Cs-7947

31. Db12548

32. Sb16876

33. Dara-a (dual Acting Receptor Antagonist Of Angiotension And Endothelin Receptors)

34. Ps-433540;re-021;dara

35. Ac-35179

36. Hy-17621

37. Sparsentan (ps-433540,re-021,dara)

38. D11776

39. F77045

40. A858308

41. L023324

42. Q27088845

43. 4''''-(2-butyl-4-oxo-1,3-diaza-spiro[4.4]non-1-en-3-ylmethyl)-2''''-ethoxymethyl-biphenyl-2-sulfonic Acid (4,5-dimethyl-isoxazol-3-yl)-amide

44. 4''-(2-butyl-4-oxo-1,3-diaza-spiro[4.4]non-1-en-3-ylmethyl)-2''-ethoxymethyl-biphenyl-2-sulfonic Acid (4,5-dimethyl-isoxazol-3-yl)-amide

45. 4'-((2-butyl-4-oxo-1,3-diazaspiro(4.4)non-1-en-3-yl)methyi)-n-(4,5- Dimethylisoxazol-3-yl)-2'-(ethoxymethyl)biphenyl-2-sulfonamide

46. 4'-((2-butyl-4-oxo-1,3-diazaspiro(4.4)non-1-en-3-yl)methyl)-n-(4,5-dimethyl-1,2-oxazol-3-yl)-2'-(ethoxymethyl)-2-biphenylsulfonamide

47. 4'-((2-butyl-4-oxo-1,3-diazaspiro(4.4)non-1-en-3-yl)methyl)-n-(4,5-dimethyl-1,2-oxazol-3-yl)-2'-(ethoxymethyl)biphenyl-2-sulfonamide

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 592.8 g/mol
Molecular Formula C32H40N4O5S
XLogP35
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count8
Rotatable Bond Count12
Exact Mass592.27194156 g/mol
Monoisotopic Mass592.27194156 g/mol
Topological Polar Surface Area123 Ų
Heavy Atom Count42
Formal Charge0
Complexity1060
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Treatment of focal segmental glomerulosclerosis


Treatment of primary IgA nephropathy


5 Pharmacology and Biochemistry
5.1 Mechanism of Action

Sparsentan, which possesses two clinically validated mechanisms of action in a single molecule, works by selectively blocking the action of two potent vasoconstrictor and mitogenic agents, angiotensin II (AII) and endothelin 1 (ET1), at their respective receptors. Sparsentan is highly selective (10,000-fold) for the AII receptor sub-type 1 and the ET receptor sub-type A. As such, Sparsentan combines the properties of an angiotensin receptor blocker (ARB) and an endothelin receptor antagonist (ERA) in the same molecule.


USDMF

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GDUFA

DMF Review : Complete

Rev. Date : 2025-11-17

Pay. Date : 2025-09-26

DMF Number : 41498

Submission : 2025-03-29

Status : Active

Type : II

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NDC API

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SPARSENTAN

NDC Package Code : 72640-038

Start Marketing Date : 2025-03-29

End Marketing Date : 2026-12-31

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

Marketing Category : BULK INGREDIENT

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SPARSENTAN

NDC Package Code : 24538-021

Start Marketing Date : 2023-02-17

End Marketing Date : 2026-12-31

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

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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Seqens

France
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Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Sparsentan

About the Company : Founded in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. The company supports customers in the development, scale-up, and man...

Founded in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. The company supports customers in the development, scale-up, and manufacturing of drug substances from pre-clinical to commercial stages. Seqens offers a broad portfolio of APIs and proprietary products, along with custom solutions for healthcare, electronics, and cosmetics. With 16 industrial plants and 9 R&D centers worldwide, Seqens produces complex molecules across small- and large-scale requirements. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Virtual BoothMaithri Drugs: Dedicated to your API needs.

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Sparsentan

About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...

Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, antibiotics, ARVs, CNS, and cardiovascular segments. The company operates facilities approved by US FDA, EDQM, Health Canada, and WHO-GMP, supported by multiple global DMFs and Ecovadis recognition. Backed by strong R&D, global patents, and customer-focused practices, Maithri delivers high-quality APIs with regulatory excellence. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Sparsentan

About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...

Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. 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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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Sparsentan

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 BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Sparsentan

About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...

Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios with over 350 products, alongside tailored CDMO services. Leveraging deep expertise and diverse technologies, we deliver flexible, high-quality solutions to meet our partners’ needs. 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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Sparsentan

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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Sparsentan

About the Company : Daishang Chemical Co., Ltd. established in January 2005, sticking to the guiding principle "Technical innovation, Quality Orientation", we practice best of technology innovation, o...

Daishang Chemical Co., Ltd. established in January 2005, sticking to the guiding principle "Technical innovation, Quality Orientation", we practice best of technology innovation, optimized management and robust service system for our customers. Daishang Chem is specialized in the researching, manufacturing, sales and marketing of API & Its Intermediates as well as other Fine Chemicals, taking great advantages of professional and proficient staff, based on three chemical manufacturing sites and one GMP manufacturing workshops in Liaoning, Henan and Zhejiang provinces, and one R&D laboratory in Zhangjiang Hi-tech Park.
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Sparsentan

About the Company : Founded by chemists with years of working experiences in famous CRO companies in China, Excenen Pharmatech experienced in organic chemistry expecially in medicinal chemistry resear...

Founded by chemists with years of working experiences in famous CRO companies in China, Excenen Pharmatech experienced in organic chemistry expecially in medicinal chemistry research/discovery fields. Excenen PharmaTech is dedicated to serve the pharmaceutical, scientific research and development industries for 10 years. During the past 10 years we supplied building blocks, small molecules, inhitbitors to world's leading companies like Janssen (Johnson&Johnson), Gilead, Abbvie..., Universities like Duke University, University of Chicago, University of Barcelona, University of Pécs etc.
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FandaChem

China
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FandaChem

China
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Sparsentan

About the Company : FandaChem, headquartered in Hangzhou, China, is a reputable supplier and exporter of chemicals with a focus on delivering high-quality products. Our expertise lies in exporting a w...

FandaChem, headquartered in Hangzhou, China, is a reputable supplier and exporter of chemicals with a focus on delivering high-quality products. Our expertise lies in exporting a wide range of superior chemicals, specializing in areas such as agrochemicals, flavors, fragrances, pharmaceuticals, intermediates, paints, resins, plastics, surfactants, polymers, cosmetics, and more. Dedicated to being your dependable partner in China, FandaChem is devoted to offering top-notch products, competitive prices, and excellent service to meet the needs of our customers.
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Sparsentan

About the Company : Hebi Xinhe Pharmaceutical Co., Ltd. is a subsidiary of Tianjin Zhennuo Pharmaceutical Group Co., Ltd., with a registered capital of CNY 100 million. Located in Jijiashan Industrial...

Hebi Xinhe Pharmaceutical Co., Ltd. is a subsidiary of Tianjin Zhennuo Pharmaceutical Group Co., Ltd., with a registered capital of CNY 100 million. Located in Jijiashan Industrial Park in Heshan District, Hebi City, the company spans 146,200 square meters, with a planned construction area of 80,300 square meters and a total investment of CNY 750 million. Our facilities include production plants, warehouses, office buildings, fire safety infrastructure, and waste treatment systems.
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API Reference Price

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29-Oct-2025
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INTERMEDIATE SUPPLIERS

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Vitafoods India
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CAS Number : 151257-01-1

End Use API : Sparsentan

About The Company : Corey Organics is focused in developing and manufacturing of Active Pharmaceutical Ingredients (APIs), registered Pharma Intermediates, Fine Chemicals and Pyrid...

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Vitafoods India
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CAS Number : 138401-24-8

End Use API : Sparsentan

About The Company : Corey Organics is focused in developing and manufacturing of Active Pharmaceutical Ingredients (APIs), registered Pharma Intermediates, Fine Chemicals and Pyrid...

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Sparsentan manufacturers, exporters & distributors 1

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API | Excipient name

Sparsentan

Synonyms

254740-64-2, Sparsentan (re-021), Re-021, Sparsentan [usan], Ps433540, Ps-433540

Cas Number

254740-64-2

Unique Ingredient Identifier (UNII)

9242RO5URM

About Sparsentan

Sparsentan has been used in trials studying the treatment of Focal Segmental Glomerulosclerosis. Sparsentan is the first and only dual-acting angiotensin and endothelin receptor antagonist (DARA) in development.

Sparsentan Manufacturers

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

Sparsentan Suppliers

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

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

Sparsentan USDMF

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

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

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

Sparsentan 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 Sparsentan as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Sparsentan GMP

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

Sparsentan CoA

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

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

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