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1. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2h-pyran-3,4,5-triol
2. Lx-4211
3. Lx4211
1. 1018899-04-1
2. Lx-4211
3. Lx4211
4. Lp-802034
5. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2h-pyran-3,4,5-triol
6. 6b4zbs263y
7. Sar439954
8. Sar-439954
9. (2s,3r,4r,5s,6r)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-methylsulfanyloxane-3,4,5-triol
10. Zynquista
11. Beta-l-xylopyranoside, Methyl 5-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-1-thio-, (5s)-
12. Sotagliflozin [usan:inn]
13. Unii-6b4zbs263y
14. Beta-l-xylopyranoside, Methyl 5-c-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-1-thio-, (5s)-
15. Mfcd22493506
16. Lx 4211
17. Lp 802034
18. Sotagliflozin [mi]
19. Sotagliflozin (lx4211)
20. Sotagliflozin [inn]
21. Sotagliflozin (usan/inn)
22. Sotagliflozin [usan]
23. Sotagliflozin (lx-4211)
24. Sotagliflozin [who-dd]
25. Gtpl8312
26. Schembl1038287
27. Chembl3039507
28. Dtxsid20144314
29. Amy12393
30. Ex-a1167
31. Bdbm50235017
32. S8103
33. Zinc95641922
34. Akos025290846
35. Ccg-268940
36. Cs-1069
37. Db12713
38. Ac-29890
39. As-35202
40. Bl161424
41. Hy-15516
42. D10669
43. A852129
44. Q27088840
45. (2s,3r,4r,5s,6r)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-tetrahydro-6-(methylthio)-2h-pyran-3,4,5-triol;lx4211
46. (2s,3r,4r,5s,6r)-2-[4-chloro-3-(4-ethoxybenzyl)phenyl]-6-(methylsulfanyl)tetrahydro-2h-pyran-3,4,5-triol
47. .beta.-l-xylopyranoside, Methyl 5-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-1-thio-, (5s)-
48. Methyl (5s)-5-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-1-thio-.beta.-l-xylopyranoside
Molecular Weight | 424.9 g/mol |
---|---|
Molecular Formula | C21H25ClO5S |
XLogP3 | 3.2 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 6 |
Exact Mass | 424.1111228 g/mol |
Monoisotopic Mass | 424.1111228 g/mol |
Topological Polar Surface Area | 104 Ų |
Heavy Atom Count | 28 |
Formal Charge | 0 |
Complexity | 476 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 5 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.
Treatment of type II diabetes mellitus
Treatment of type I diabetes mellitus
Sodium-Glucose Transporter 2 Inhibitors
Compounds that inhibit SODIUM-GLUCOSE TRANSPORTER 2. They lower blood sugar by preventing the reabsorption of glucose by the kidney and are used in the treatment of TYPE 2 DIABETES MELLITUS. (See all compounds classified as Sodium-Glucose Transporter 2 Inhibitors.)
A10
A - Alimentary tract and metabolism
A10 - Drugs used in diabetes
A10B - Blood glucose lowering drugs, excl. insulins
A10BK - Sodium-glucose co-transporter 2 (sglt2) inhibitors
A10BK06 - Sotagliflozin
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41249
Submission : 2025-01-27
Status : Active
Type : II
NDC Package Code : 48087-0150
Start Marketing Date : 2019-12-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...
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...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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...
About the Company : Founded in 1997, Lee Pharma Limited has transformed from a small venture into a global leader in the pharmaceutical industry. Our journey began with a commitment to providing affor...
About the Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide range of therapeutic cat...
About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (N...
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Details:
Zynquista (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.
Lead Product(s): Sotagliflozin
Therapeutic Area: Endocrinology Brand Name: Zynquista
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 20, 2024
Lead Product(s) : Sotagliflozin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lexicon Announces Receipt of Complete Response Letter for Zynquista™ (sotagliflozin)
Details : Zynquista (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.
Product Name : Zynquista
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 20, 2024
Details:
Inpefa (sotagliflozin), an SGLT2/SGLT1 inhibitor, is in phase III trials for treating type 1 diabetes and chronic kidney failure.
Lead Product(s): Sotagliflozin
Therapeutic Area: Endocrinology Brand Name: SAR439954
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 03, 2024
Lead Product(s) : Sotagliflozin
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Post Hoc Analysis Shows Sotagliflozin Improves Glycemic Control in Type 1
Details : Inpefa (sotagliflozin), an SGLT2/SGLT1 inhibitor, is in phase III trials for treating type 1 diabetes and chronic kidney failure.
Product Name : SAR439954
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 03, 2024
Details:
Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.
Lead Product(s): Sotagliflozin
Therapeutic Area: Endocrinology Brand Name: SAR439954
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Sanofi
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 03, 2024
Lead Product(s) : Sotagliflozin
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Sanofi
Deal Size : Inapplicable
Deal Type : Inapplicable
Lexicon Prepares to Resubmit Sotagliflozin NDA for Type 1 Diabetes After FDA Feedback
Details : Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.
Product Name : SAR439954
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 03, 2024
Details:
Zynquista (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.
Lead Product(s): Sotagliflozin
Therapeutic Area: Endocrinology Brand Name: SAR439954
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 31, 2024
Lead Product(s) : Sotagliflozin
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lexicon Announces FDA Advisory Outcome for Zynquista™ in Type 1 Diabetes with CKD
Details : Zynquista (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.
Product Name : SAR439954
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 31, 2024
Details:
Under the license agreement, Viatris will acquire the rights to Inpefa (sotagliflozin) from Lexicon for the treatment of heart failure and type 2 diabetes in all markets outside the U.S. and Europe.
Lead Product(s): Sotagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: SAR439954
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Viatris
Deal Size: Undisclosed Upfront Cash: $25.0 million
Deal Type: Licensing Agreement October 16, 2024
Lead Product(s) : Sotagliflozin
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Viatris
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Viatris Licenses Sotagliflozin from Lexicon Outside U.S. and Europe
Details : Under the license agreement, Viatris will acquire the rights to Inpefa (sotagliflozin) from Lexicon for the treatment of heart failure and type 2 diabetes in all markets outside the U.S. and Europe.
Product Name : SAR439954
Product Type : Other Small Molecule
Upfront Cash : $25.0 million
October 16, 2024
Details:
Zynquista (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.
Lead Product(s): Sotagliflozin
Therapeutic Area: Endocrinology Brand Name: SAR439954
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 21, 2024
Lead Product(s) : Sotagliflozin
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lexicon Pharmaceuticals Announces FDA Advisory Committee Meeting for Zynquista
Details : Zynquista (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.
Product Name : SAR439954
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 21, 2024
Details:
Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.
Lead Product(s): Sotagliflozin
Therapeutic Area: Endocrinology Brand Name: SAR439954
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 16, 2024
Lead Product(s) : Sotagliflozin
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lexicon Pharmaceuticals Receives PDUFA Goal Date for Sotagliflozin NDA Resubmission
Details : Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.
Product Name : SAR439954
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 16, 2024
Details:
Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.
Lead Product(s): Sotagliflozin
Therapeutic Area: Endocrinology Brand Name: SAR439954
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 21, 2024
Lead Product(s) : Sotagliflozin
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes
Details : Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.
Product Name : SAR439954
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 21, 2024
Details:
Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.
Lead Product(s): Sotagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: SAR439954
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 14, 2024
Lead Product(s) : Sotagliflozin
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Analysis Shows INPEFA Reduced Heart Failure Risk in Preserved Ejection Fraction Patients
Details : Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is being evaluated for the treatment of type 1 diabetes and chronic kidney disease.
Product Name : SAR439954
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 14, 2024
Details:
Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is indicated for the treatment of heart failure in patients with type 1 diabetes.
Lead Product(s): Sotagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: SAR439954
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 09, 2024
Lead Product(s) : Sotagliflozin
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Gardasil Approved for Prevention of HPV-Caused Cancers
Details : Inpefa (sotagliflozin) is a small molecule dual inhibitor of SGLT1 and SGLT2, which is indicated for the treatment of heart failure in patients with type 1 diabetes.
Product Name : SAR439954
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 09, 2024
Regulatory Info : RX
Registration Country : USA
Brand Name : INPEFA
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2023-05-26
Application Number : 216203
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : INPEFA
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG
Packaging :
Approval Date : 2023-05-26
Application Number : 216203
Regulatory Info : RX
Registration Country : USA
RLD : Yes
TE Code :
Brand Name : INPEFA
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Approval Date : 2023-05-26
Application Number : 216203
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : INPEFA
Dosage Form : TABLET;ORAL
Dosage Strength : 400MG
Approval Date : 2023-05-26
Application Number : 216203
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Market Place
Reply
21 Sep 2023
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10 Apr 2021
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07 Oct 2020
Reply
12 Oct 2019
Patents & EXCLUSIVITIES
Patent Expiration Date : 2028-05-04
US Patent Number : 7781577
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 216203
Patent Use Code : U-3628
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-05-04
Patent Expiration Date : 2028-05-04
US Patent Number : 7781577
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 216203
Patent Use Code : U-3628
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-05-04
Patent Expiration Date : 2030-10-07
US Patent Number : 8217156
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 216203
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-10-07
Patent Expiration Date : 2030-10-07
US Patent Number : 8217156
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 216203
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-10-07
Patent Expiration Date : 2028-05-29
US Patent Number : 8476413
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 216203
Patent Use Code : U-3628
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-05-29
Patent Expiration Date : 2028-05-29
US Patent Number : 8476413
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 216203
Patent Use Code : U-3628
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-05-29
Exclusivity Code : NCE
Exclusivity Expiration Date : 2028-05-26
Application Number : 216203
Product Number : 1
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2028-05-26
Application Number : 216203
Product Number : 2
Exclusivity Details :
ABOUT THIS PAGE
52
PharmaCompass offers a list of Sotagliflozin 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 Sotagliflozin manufacturer or Sotagliflozin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sotagliflozin manufacturer or Sotagliflozin supplier.
PharmaCompass also assists you with knowing the Sotagliflozin API Price utilized in the formulation of products. Sotagliflozin API Price is not always fixed or binding as the Sotagliflozin Price is obtained through a variety of data sources. The Sotagliflozin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sotagliflozin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sotagliflozin, including repackagers and relabelers. The FDA regulates Sotagliflozin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sotagliflozin 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 Sotagliflozin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sotagliflozin supplier is an individual or a company that provides Sotagliflozin active pharmaceutical ingredient (API) or Sotagliflozin finished formulations upon request. The Sotagliflozin suppliers may include Sotagliflozin API manufacturers, exporters, distributors and traders.
click here to find a list of Sotagliflozin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sotagliflozin DMF (Drug Master File) is a document detailing the whole manufacturing process of Sotagliflozin active pharmaceutical ingredient (API) in detail. Different forms of Sotagliflozin DMFs exist exist since differing nations have different regulations, such as Sotagliflozin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sotagliflozin DMF submitted to regulatory agencies in the US is known as a USDMF. Sotagliflozin USDMF includes data on Sotagliflozin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sotagliflozin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sotagliflozin suppliers with USDMF on PharmaCompass.
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 Sotagliflozin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sotagliflozin API and other APIs are published in this directory by the FDA.
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 Sotagliflozin 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.
The NDC directory also contains data on finished compounded human drug products that contain Sotagliflozin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sotagliflozin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sotagliflozin suppliers with NDC on PharmaCompass.
Sotagliflozin 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 Sotagliflozin 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 Sotagliflozin GMP manufacturer or Sotagliflozin GMP API supplier for your needs.
A Sotagliflozin CoA (Certificate of Analysis) is a formal document that attests to Sotagliflozin's compliance with Sotagliflozin specifications and serves as a tool for batch-level quality control.
Sotagliflozin CoA mostly includes findings from lab analyses of a specific batch. For each Sotagliflozin 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.
Sotagliflozin may be tested according to a variety of international standards, such as European Pharmacopoeia (Sotagliflozin EP), Sotagliflozin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sotagliflozin USP).