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1. 775351-61-6
2. Imeglimin (hydrochloride)
3. Imeglimin Hcl
4. Imeglimin Monohydrochloride
5. Mn7p3p5byb
6. Emd 387008 Hydrochloride
7. Imeglimin Hydrochloride [jan]
8. Imeglimin Hydrochloride [who-dd]
9. Imeglimin Hydrochloride (jan)
10. (4r)-6-n,6-n,4-trimethyl-1,4-dihydro-1,3,5-triazine-2,6-diamine;hydrochloride
11. 1,3,5-triazine-2,4-diamine, 3,6-dihydro-n2,n2,6-trimethyl-, Hydrochloride (1:1), (6r)-
12. 2650481-44-8
13. R-imeglimin Hydrochloride
14. Unii-mn7p3p5byb
15. Schembl2157885
16. (r)-n2,n2,6-trimethyl-1,6-dihydro-1,3,5-triazine-2,4-diamine Hydrochloride
17. Bcp11078
18. Hy-14771a
19. Mfcd28167741
20. Akos037643759
21. As-35168
22. D11807
23. A914496
24. Emd 387008 Hydrochloride;emd387008 Hydrochloride;emd-387008 Hydrochloride
| Molecular Weight | 191.66 g/mol |
|---|---|
| Molecular Formula | C6H14ClN5 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 1 |
| Exact Mass | 191.0937732 g/mol |
| Monoisotopic Mass | 191.0937732 g/mol |
| Topological Polar Surface Area | 66 Ų |
| Heavy Atom Count | 12 |
| Formal Charge | 0 |
| Complexity | 205 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36107
Submission : 2021-07-20
Status : Active
Type : II
NDC Package Code : 42765-038
Start Marketing Date : 2021-07-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
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Drugs in Development
Details:
Glimcoza (Imeglimin HCl) is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.
Lead Product(s): Imeglimin Hydrochloride,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Glimcoza
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Advanced Research Network | Atco Pharma for Pharmaceutical Ind.
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 17, 2025
Lead Product(s) : Imeglimin Hydrochloride,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Advanced Research Network | Atco Pharma for Pharmaceutical Ind.
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioequivalence of Two Imeglimin Hydrochloride Film Coated Tablet Formulations
Details : Glimcoza (Imeglimin HCl) is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.
Product Name : Glimcoza
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 17, 2025
Details:
The financing will be used to monetize a portion of Poxel's future royalties and sales-based payments from Twymeeg (imeglimin) sales by Sumitomo Pharma in Japan.
Lead Product(s): Imeglimin Hydrochloride,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Twymeeg
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: OrbiMed Advisors
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Financing September 30, 2024
Lead Product(s) : Imeglimin Hydrochloride,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : OrbiMed Advisors
Deal Size : $50.0 million
Deal Type : Financing
Poxel Monetizes TWYMEEG® Royalties For $50M in Deal with OrbiMed
Details : The financing will be used to monetize a portion of Poxel's future royalties and sales-based payments from Twymeeg (imeglimin) sales by Sumitomo Pharma in Japan.
Product Name : Twymeeg
Product Type : Miscellaneous
Upfront Cash : Undisclosed
September 30, 2024
Details:
TWYMEEG (imeglimin hydrochloride), enhances insulin action by inhibiting hepatic glucose output and improving insulin signalling in both liver and skeletal muscle, in type 2 diabetes patients.
Lead Product(s): Imeglimin Hydrochloride,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Twymeeg
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Poxel
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 07, 2024
Lead Product(s) : Imeglimin Hydrochloride,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Poxel
Deal Size : Inapplicable
Deal Type : Inapplicable
Sumitomo And Poxel Announce TWYMEEG® Study Results For Type 2 Diabetes Treatment
Details : TWYMEEG (imeglimin hydrochloride), enhances insulin action by inhibiting hepatic glucose output and improving insulin signalling in both liver and skeletal muscle, in type 2 diabetes patients.
Product Name : Twymeeg
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 07, 2024
Details:
Imeglimin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Lead Product(s): Imeglimin Hydrochloride,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Sumitomo Pharma
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 09, 2022
Lead Product(s) : Imeglimin Hydrochloride,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Sumitomo Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus
Details : Imeglimin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 09, 2022
Details:
The companies entered into a strategic partnership for the development and commercialization of Twymeeg (imeglimin hydrochloride) in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries.
Lead Product(s): Imeglimin Hydrochloride,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Twymeeg
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Sumitomo Pharma
Deal Size: $299.0 million Upfront Cash: $42.0 million
Deal Type: Partnership June 23, 2021
Lead Product(s) : Imeglimin Hydrochloride,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Sumitomo Pharma
Deal Size : $299.0 million
Deal Type : Partnership
Poxel and Sumitomo Dainippon Pharma Announce the Approval of TWYMEEG® (Imeglimin hydrochloride) f...
Details : The companies entered into a strategic partnership for the development and commercialization of Twymeeg (imeglimin hydrochloride) in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries.
Product Name : Twymeeg
Product Type : Miscellaneous
Upfront Cash : $42.0 million
June 23, 2021
Details:
Metavant will return all rights to Imeglimin to Poxel, as well as all data, materials, and information, including FDA regulatory filings, related to the program. Metavant is not entitled to any payment from Poxel as part of the return of the program.
Lead Product(s): Imeglimin Hydrochloride,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Twymeeg
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Metavant Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Termination January 14, 2021
Lead Product(s) : Imeglimin Hydrochloride,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Metavant Sciences
Deal Size : Undisclosed
Deal Type : Termination
Poxel Regains Imeglimin Rights From Metavant
Details : Metavant will return all rights to Imeglimin to Poxel, as well as all data, materials, and information, including FDA regulatory filings, related to the program. Metavant is not entitled to any payment from Poxel as part of the return of the program.
Product Name : Twymeeg
Product Type : Miscellaneous
Upfront Cash : Undisclosed
January 14, 2021
Details:
Metavant has conducted a strategic review and has decided not to move forward with the development of Imeglimin. Metavant will actively explore options for a potential out-licensing of Imeglimin rights for a period of 60 day.
Lead Product(s): Imeglimin Hydrochloride,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Twymeeg
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Poxel
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 20, 2020
Lead Product(s) : Imeglimin Hydrochloride,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Poxel
Deal Size : Inapplicable
Deal Type : Inapplicable
Poxel Provides Update on Metavant Partnership with Imeglimin
Details : Metavant has conducted a strategic review and has decided not to move forward with the development of Imeglimin. Metavant will actively explore options for a potential out-licensing of Imeglimin rights for a period of 60 day.
Product Name : Twymeeg
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 20, 2020
Details:
Phase 3 TIMES 2 and TIMES 3 trial results demonstrate that Imeglimin met its primary endpoints and objectives and was observed to exhibit a favorable safety and tolerability profile.
Lead Product(s): Imeglimin Hydrochloride,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Twymeeg
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 24, 2020
Lead Product(s) : Imeglimin Hydrochloride,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Phase 3 TIMES 2 and TIMES 3 trial results demonstrate that Imeglimin met its primary endpoints and objectives and was observed to exhibit a favorable safety and tolerability profile.
Product Name : Twymeeg
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 24, 2020
Details:
Sumitomo Dainippon Pharma has submitted a Japanese New Drug Application (J-NDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) to request approval for the manufacturing and marketing of Imeglimin for the treatment of type 2 diabetes.
Lead Product(s): Imeglimin Hydrochloride,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Twymeeg
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Sumitomo Pharma
Deal Size: $21.3 million Upfront Cash: Undisclosed
Deal Type: Agreement July 30, 2020
Lead Product(s) : Imeglimin Hydrochloride,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Sumitomo Pharma
Deal Size : $21.3 million
Deal Type : Agreement
Details : Sumitomo Dainippon Pharma has submitted a Japanese New Drug Application (J-NDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) to request approval for the manufacturing and marketing of Imeglimin for the treatment of type 2 diabetes.
Product Name : Twymeeg
Product Type : Miscellaneous
Upfront Cash : Undisclosed
July 30, 2020
Details:
Two drug-drug interaction studies assessed the effect of repeated co-administration of commonly prescribed medications, metformin or sitagliptin (Januvia®; Merck & Co.), with Imeglimin.
Lead Product(s): Imeglimin Hydrochloride,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Twymeeg
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 20, 2020
Lead Product(s) : Imeglimin Hydrochloride,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Poxel Announces Publication of Imeglimin Clinical Study Results in Clinical Pharmacokinetics
Details : Two drug-drug interaction studies assessed the effect of repeated co-administration of commonly prescribed medications, metformin or sitagliptin (Januvia®; Merck & Co.), with Imeglimin.
Product Name : Twymeeg
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 20, 2020
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Regulatory Info :
Registration Country : Egypt
Imeglimin hydrochloride 775351-61-6
Brand Name : Imeglimtz
Dosage Form : Film Coated Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Egypt
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 1000MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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PharmaCompass offers a list of Imeglimin Hydrochloride 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 Imeglimin Hydrochloride manufacturer or Imeglimin Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Imeglimin Hydrochloride manufacturer or Imeglimin Hydrochloride supplier.
PharmaCompass also assists you with knowing the Imeglimin Hydrochloride API Price utilized in the formulation of products. Imeglimin Hydrochloride API Price is not always fixed or binding as the Imeglimin Hydrochloride Price is obtained through a variety of data sources. The Imeglimin Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Imeglimin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Imeglimin Hydrochloride, including repackagers and relabelers. The FDA regulates Imeglimin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Imeglimin Hydrochloride 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 Imeglimin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Imeglimin Hydrochloride supplier is an individual or a company that provides Imeglimin Hydrochloride active pharmaceutical ingredient (API) or Imeglimin Hydrochloride finished formulations upon request. The Imeglimin Hydrochloride suppliers may include Imeglimin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Imeglimin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Imeglimin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Imeglimin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Imeglimin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Imeglimin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Imeglimin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Imeglimin Hydrochloride USDMF includes data on Imeglimin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Imeglimin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Imeglimin Hydrochloride 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 Imeglimin Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Imeglimin Hydrochloride 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 Imeglimin Hydrochloride 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 Imeglimin Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Imeglimin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Imeglimin Hydrochloride suppliers with NDC on PharmaCompass.
Imeglimin Hydrochloride 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 Imeglimin Hydrochloride 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 Imeglimin Hydrochloride GMP manufacturer or Imeglimin Hydrochloride GMP API supplier for your needs.
A Imeglimin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Imeglimin Hydrochloride's compliance with Imeglimin Hydrochloride specifications and serves as a tool for batch-level quality control.
Imeglimin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Imeglimin Hydrochloride 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.
Imeglimin Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Imeglimin Hydrochloride EP), Imeglimin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Imeglimin Hydrochloride USP).
