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Also known as: 960404-48-2, Dapagliflozin propanediol monohydrate, Dapagliflozin propanediol hydrate, Farxiga, Dapagliflozin ((2s)-1,2-propanediol, hydrate), Bms-512148-05
Molecular Formula
C24H35ClO9
Molecular Weight
503.0  g/mol
InChI Key
GOADIQFWSVMMRJ-UPGAGZFNSA-N
FDA UNII
887K2391VH

Dapagliflozin Propanediol Monohydrate
Dapagliflozin Propanediol is the propanediol form of dapagliflozin, a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Upon administration, dapagliflozin selectively targets and inhibits SGLT2, thereby preventing the reabsorption of glucose by the kidneys.
1 2D Structure

Dapagliflozin Propanediol Monohydrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S,3R,4R,5S,6R)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol;(2S)-propane-1,2-diol;hydrate
2.1.2 InChI
InChI=1S/C21H25ClO6.C3H8O2.H2O/c1-2-27-15-6-3-12(4-7-15)9-14-10-13(5-8-16(14)22)21-20(26)19(25)18(24)17(11-23)28-21;1-3(5)2-4;/h3-8,10,17-21,23-26H,2,9,11H2,1H3;3-5H,2H2,1H3;1H2/t17-,18-,19+,20-,21+;3-;/m10./s1
2.1.3 InChI Key
GOADIQFWSVMMRJ-UPGAGZFNSA-N
2.1.4 Canonical SMILES
CCOC1=CC=C(C=C1)CC2=C(C=CC(=C2)C3C(C(C(C(O3)CO)O)O)O)Cl.CC(CO)O.O
2.1.5 Isomeric SMILES
CCOC1=CC=C(C=C1)CC2=C(C=CC(=C2)[C@H]3[C@@H]([C@H]([C@@H]([C@H](O3)CO)O)O)O)Cl.C[C@@H](CO)O.O
2.2 Other Identifiers
2.2.1 UNII
887K2391VH
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol

2. 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2h-pyran-3,4,5-triol

3. Bms 512148

4. Bms-512148

5. Bms512148

6. Dapagliflozin

7. Farxiga

8. Forxiga

2.3.2 Depositor-Supplied Synonyms

1. 960404-48-2

2. Dapagliflozin Propanediol Monohydrate

3. Dapagliflozin Propanediol Hydrate

4. Farxiga

5. Dapagliflozin ((2s)-1,2-propanediol, Hydrate)

6. Bms-512148-05

7. Dapagliflozin S-propylene Glycol Monohydrate

8. Dapagliflozin Propylene Glycolate Hydrate

9. Chebi:85079

10. Dapagliflozin Propanediol [usan]

11. Dapagliflozin Mixture With Propylene Glycol, Hydrate

12. 887k2391vh

13. (2s,3r,4r,5s,6r)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol;(2s)-propane-1,2-diol;hydrate

14. Dapagliflozin [usan:inn]

15. Dapagliflozin Propylene Glycol Hydrate

16. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol Compound With (s)-propane-1,2-diol (1:1) Hydrate

17. D-glucitol, 1,5-anhydro-1-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-, (1s)-, Compd. With (2s)-1,2-propanediol, Hydrate (1:1:1)

18. Unii-887k2391vh

19. Dapagliflozin Propylene Glycolate Hydrate [jan]

20. Dapagliflozin (s)-propylene Glycol Hydrate

21. Chembl2103802

22. Dtxsid00914678

23. Ex-a2824

24. Dapagliflozin Propylene Glycol

25. Hy-10450a

26. Mfcd28167768

27. S5566

28. Akos027250601

29. Ccg-269711

30. Ac-29230

31. As-64915

32. Dapagliflozin (2s)-1,2-propanediol Hydrate

33. F20667

34. Bms-512148 (2s)-1,2-propanediol, Hydrate

35. Dapagliflozin (2s)-1,2-propanediol Monohydrate

36. Xigduo Component Dapagliflozin Propanediol

37. A900162

38. Dapagliflozin Propanediol Component Of Xigduo

39. Dapagliflozin Propanediol Monohydrate [who-dd]

40. Q27158320

41. Dapagliflozin Propanediol Monohydrate [ema Epar]

42. Dapagliflozin Compound With (2s)-1,2-propanediol Hydrate

43. Dapagliflozin Compound With (2s)-1,2-propanediol Hydrate [mi]

44. (2s)-propane-1,2-diol (2s,3r,4r,5s,6r)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol Hydrate

45. (2s)-propane-1,2-diol--(1s)-1,5-anhydro-1-[4-chloro-3-(4-ethoxybenzyl)phenyl]-d-glucitol--water (1/1/1)

46. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro- 2h-pyran-3,4,5-triol, (2s)-propane-1,2-diol (1:1) Monohydrate

47. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol (s)-propane-1,2-diol Hydrate

48. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol, (2s)-propane-1,2-diol (1:1) Monohydrate

49. 1700615-13-9

2.4 Create Date
2008-09-29
3 Chemical and Physical Properties
Molecular Weight 503.0 g/mol
Molecular Formula C24H35ClO9
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count9
Rotatable Bond Count7
Exact Mass502.1969604 g/mol
Monoisotopic Mass502.1969604 g/mol
Topological Polar Surface Area141 Ų
Heavy Atom Count34
Formal Charge0
Complexity493
Isotope Atom Count0
Defined Atom Stereocenter Count6
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Indication

Forxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

- as monotherapy when metformin is considered inappropriate due to intolerance.

- in addition to other medicinal products for the treatment of type 2 diabetes.

For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied.

Heart failure

- Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.

Chronic kidney disease

- Forxiga is indicated in adults for the treatment of chronic kidney disease.


Type 2 diabetes mellitus

Edistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

- as monotherapy when metformin is considered inappropriate due to intolerance.

- in addition to other medicinal products for the treatment of type 2 diabetes.

For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 and 5. 1.

Heart failure

Edistride is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.

Chronic kidney disease

Edistride is indicated in adults for the treatment of chronic kidney disease.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


5.2 ATC Code

A10BK01


A10BK01


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Polpharma

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Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Dapagliflozin Propanediol Monohydrate

About the Company : Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API...

Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API development to scale-up, at our FDA-approved plant in Central Europe. Our expert team provides high-quality, tailor-made services for small molecule API clinical candidates, with strong regulatory support and world-class facilities. Trusted by global partners, we specialize in complex chemical processes and deliver exceptional customer experiences. Polpharma API – Your reliable European CDMO partner.
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Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Dapagliflozin Propanediol Monohydrate

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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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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Dapagliflozin Propanediol Monohydrate

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 BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

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Dapagliflozin Propanediol

About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...

Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has 6 workshops and 9 production lines which has 100t/month production capacity.The company is committed to maintain the standards with continuous improvements to the current standards throughout the product lifecycle.The main products include local anesthetic drugs, antiviral drugs, cardiovascular and cerebrovascular drugs, antitumor drugs, gastrointestinal drugs, diabetic drugs, veterinary drugs, and CDMO products.
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Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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Dapagliflozin Propanediol

About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...

Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the pharmaceutical industry’s chemistry requirements, from the synthesis of library compounds to supplying NCEs and advanced intermediates at various stages in the clinical life cycle, as well as commercial launch. Neuland’s expertise is in the manufacturing of APIs and advanced intermediates from its USFDA-approved facilities. Its core competency lies in the application of powerful process chemistry to manufacturing in a regulatory-compliant environment.
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Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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Dapagliflozin Propanediol Monohydrate

About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...

Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our expertise in complex chemistries, we provide end-to-end CDMO services to global innovators and have delivered numerous projects from concept to commercialization over the years.As a global API player, we serve customers across nearly 60 countries with 80+ molecules backed by robust R&D, regulatory capabilities and manufacturing infrastructure. We are among the top backward integrated exporters of pellets and have strong development and manufacturing capabilities.
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Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Dapagliflozin Propanediol

About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...

Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its products under Egis’ brand names in 18 countries. In total, the company’s APIs & finished products reach 100 countries. Egis’ focus lies on treating diseases of cardiovascular & central nervous systems; however, it also provides modern treatment solutions in the fields of diabetology, dermatology & wound care. Our research and development activities focus on high-quality, value-added branded generic products. From 2023, Egis offers its CDMO & CMO services as well.
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Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.
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Virtual BoothWith Virupaksha, you get a quality product with on-time delivery.

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Dapagliflozin Propanediol

About the Company : Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of less than 20 years, the...

Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of less than 20 years, the Hyderabad-based company has grown from a single manufacturing unit to four, employing over 1,000 people. The manufacturing units are situated in Kazipally, Pashamylaram, Humnabad and Gandhi Nagar. Virupaksha's manufacturing facility holds FDA approval, reflecting its adherence to stringent standards. With a customer base exceeding 300 and a presence spanning over 70 countries, Virupaksha has established itself as a reputable global player in its field.
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S.G HIGHWAY, MAKARBA, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742149800,"product":"DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"HONOUR LAB","supplierCountry":"INDIA","foreign_port":"ALGER","customer":"EURL SOCIETE TABUK ","customerCountry":"ALGERIA","quantity":"7.00","actualQuantity":"7","unit":"KGS","unitRateFc":"2600","totalValueFC":"17286.5","currency":"USD","unitRateINR":213902.28571428571,"date":"17-Mar-2025","totalValueINR":"1497316","totalValueInUsd":"17286.5","indian_port":"Vizag-HIPL SEZ","hs_no":"29329990","bill_no":"9081232","productDescription":"API","marketType":"","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-HIPL SEZ","supplierAddress":"8-3-166\/7\/1, HETERO HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742581800,"product":"DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE","address":"2ND FLOOR, SERENE CHAMBERS,,ROAD N","city":"HYDEABAD,TELANGANA","supplier":"LAURUS LABS","supplierCountry":"INDIA","foreign_port":"LJUBLJANA - 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16-Jan-2021
26-Mar-2025
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ABOUT THIS PAGE

Looking for 1700615-13-9 / Dapagliflozin Propanediol Monohydrate API manufacturers, exporters & distributors?

Dapagliflozin Propanediol Monohydrate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Dapagliflozin Propanediol Monohydrate 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 Dapagliflozin Propanediol Monohydrate manufacturer or Dapagliflozin Propanediol Monohydrate supplier for your needs.

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

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

API | Excipient name

Dapagliflozin Propanediol Monohydrate

Synonyms

960404-48-2, Dapagliflozin propanediol hydrate, Farxiga, Dapagliflozin ((2s)-1,2-propanediol, hydrate), Bms-512148-05, Dapagliflozin s-propylene glycol monohydrate

Cas Number

1700615-13-9

Unique Ingredient Identifier (UNII)

887K2391VH

About Dapagliflozin Propanediol Monohydrate

Dapagliflozin Propanediol is the propanediol form of dapagliflozin, a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Upon administration, dapagliflozin selectively targets and inhibits SGLT2, thereby preventing the reabsorption of glucose by the kidneys.

dapagliflozin (S)-propylene glycol hydrate Manufacturers

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

dapagliflozin (S)-propylene glycol hydrate Suppliers

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

click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

dapagliflozin (S)-propylene glycol hydrate USDMF

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

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

click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with USDMF on PharmaCompass.

dapagliflozin (S)-propylene glycol hydrate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a dapagliflozin (S)-propylene glycol hydrate Drug Master File in Korea (dapagliflozin (S)-propylene glycol hydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of dapagliflozin (S)-propylene glycol hydrate. The MFDS reviews the dapagliflozin (S)-propylene glycol hydrate KDMF as part of the drug registration process and uses the information provided in the dapagliflozin (S)-propylene glycol hydrate KDMF to evaluate the safety and efficacy of the drug.

After submitting a dapagliflozin (S)-propylene glycol hydrate 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 dapagliflozin (S)-propylene glycol hydrate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with KDMF on PharmaCompass.

dapagliflozin (S)-propylene glycol hydrate WC

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

click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with Written Confirmation (WC) on PharmaCompass.

dapagliflozin (S)-propylene glycol hydrate 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 dapagliflozin (S)-propylene glycol hydrate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for dapagliflozin (S)-propylene glycol hydrate 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 dapagliflozin (S)-propylene glycol hydrate 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 dapagliflozin (S)-propylene glycol hydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a dapagliflozin (S)-propylene glycol hydrate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with NDC on PharmaCompass.

dapagliflozin (S)-propylene glycol hydrate GMP

dapagliflozin (S)-propylene glycol hydrate 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 dapagliflozin (S)-propylene glycol hydrate 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 dapagliflozin (S)-propylene glycol hydrate GMP manufacturer or dapagliflozin (S)-propylene glycol hydrate GMP API supplier for your needs.

dapagliflozin (S)-propylene glycol hydrate CoA

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

dapagliflozin (S)-propylene glycol hydrate CoA mostly includes findings from lab analyses of a specific batch. For each dapagliflozin (S)-propylene glycol hydrate 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.

dapagliflozin (S)-propylene glycol hydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (dapagliflozin (S)-propylene glycol hydrate EP), dapagliflozin (S)-propylene glycol hydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (dapagliflozin (S)-propylene glycol hydrate 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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