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Ertugliflozin L-Pyroglutamic Acid

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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26 FDF Dossiers
14 FDA Orange Book
6 Europe
6 Listed Dossiers

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1 Minakem, 2 SPI Pharma, 10 DKSH, 5 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 2 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 20 BASF, 10 Corel Pharma Chem, 6 DFE Pharma, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 30 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 NEWEDGE Overseas, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 5 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 12 Roquette, 6 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

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24 US Patents
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Synopsis

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212 RELATED EXCIPIENT COMPANIES

340EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 1210344-57-2, Pf-04971729, Steglatro, Pf04971729, (1s,2s,3s,4r,5s)-5-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol, Chembl1770248

Molecular Formula

C₂₂H₂₅ClO₇

Molecular Weight

436.9 g/mol

InChI Key

MCIACXAZCBVDEE-CUUWFGFTSA-N

FDA UNII

6C282481IP

Ertugliflozin belongs to the class of potent and selective inhibitors of the sodium-dependent glucose cotransporters (SGLT), more specifically the type 2 which is responsible for about 90% of the glucose reabsorption from glomerulus. This drug was developed under the collaboration of Merck and Pfizer. It was FDA approved as monotherapy and in combination with sitagliptin or metformin hydrochloride on December 22, 2017.

1 2D Structure

Ertugliflozin

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(1S,2S,3S,4R,5S)-5-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol

2.1.2 InChI

InChI=1S/C22H25ClO7/c1-2-28-16-6-3-13(4-7-16)9-14-10-15(5-8-17(14)23)22-20(27)18(25)19(26)21(11-24,30-22)12-29-22/h3-8,10,18-20,24-27H,2,9,11-12H2,1H3/t18-,19-,20+,21-,22-/m0/s1

2.1.3 InChI Key

MCIACXAZCBVDEE-CUUWFGFTSA-N

2.1.4 Canonical SMILES

CCOC1=CC=C(C=C1)CC2=C(C=CC(=C2)C34C(C(C(C(O3)(CO4)CO)O)O)O)Cl

2.1.5 Isomeric SMILES

CCOC1=CC=C(C=C1)CC2=C(C=CC(=C2)[C@@]34[C@@H]([C@H]([C@@H]([C@@](O3)(CO4)CO)O)O)O)Cl

2.2 Other Identifiers

2.2.1 UNII

6C282481IP

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-hydroxymethyl-6,8-dioxabicyclo(3.2.1)octane-2,3,4-triol

2. Pf 04971729

3. Pf-04971729

4. Pf04971729

5. Steglatro

2.3.2 Depositor-Supplied Synonyms

1. 1210344-57-2

2. Pf-04971729

3. Steglatro

4. Pf04971729

5. (1s,2s,3s,4r,5s)-5-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol

6. Chembl1770248

7. Pf-04971729-00

8. 6c282481ip

9. (1s,2s,3s,4r,5s)-5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol

10. Mk-8835

11. 1,6-anhydro-1-c-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-5-c-(hydroxymethyl)-beta-l-idopyranose

12. (1s,2s,3s,4r,5s)-5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-hydroxymethyl-6,8-dioxabicyclo(3.2.1)octane-2,3,4-triol

13. Pf 04971729

14. Ertugliflozin [usan:inn]

15. Unii-6c282481ip

16. (1s,2s,3s,4r,5s)-5-[4-chloro-3-(4-ethoxybenzyl)phenyl]-1-hydroxymethyl-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol

17. Ertugliflozin [mi]

18. Ertugliflozin [inn]

19. Ertugliflozin (usan/inn)

20. Ertugliflozin [usan]

21. Pf 04971729-00

22. Schembl181047

23. Ertugliflozin [who-dd]

24. Gtpl8376

25. Pf-04971729;ertugliflozin

26. Dtxsid40153120

27. Ex-a407

28. Chebi:188719

29. Ertugliflozin [orange Book]

30. Amy32613

31. Bdbm50342885

32. Mfcd21609259

33. S5413

34. Zinc68197809

35. Akos025404928

36. Stelujan Component Ertugliflozin

37. Ccg-269087

38. Cs-0976

39. Db11827

40. Segluromet Component Ertugliflozin

41. 5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-hydroxymethyl-6,8-dioxabicyclo(3.2.1)octane-2,3,4-triol

42. Ac-29007

43. As-35204

44. Beta-l-idopyranose, 1,6-anhydro-1-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-5-c-(hydroxymethyl)-

45. Ertugliflozin Component Of Stelujan

46. Hy-15461

47. Ertugliflozin Component Of Segluromet

48. D10313

49. J-504029

50. Q27077223

51. (1s,2s,3s,4r,5s)-5-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)- 1-(hydroxymethyl)-6,8-dioxabicyclo(3.2.1)octane-2,3,4-triol

52. (1s,2s,3s,4r,5s)-5-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-1-hydroxymethyl-6,8-dioxa-bicyclo[3.2.1]octane-2,3,4-triol

53. (1s,2s,3s,4r,5s)-5-[4-chloro-3-(4-ethoxybenzyl)phenyl]-1-(hydroxymethyl)-6,8-dioxa-bicyclo[3.2.1]octane-2,3,4-triol

54. (1s,5s)-1-(hydroxymethyl)-5-[3-(4-ethoxybenzyl)-4-chlorophenyl]-6,8-dioxabicyclo[3.2.1]octane-2beta,3alpha,4beta-triol

55. .beta.-l-idopyranose, 1,6-anhydro-1-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-5-c-(hydroxymethyl)-

2.4 Create Date

2010-03-15

3 Chemical and Physical Properties

Molecular Formula	C₂₂H₂₅ClO₇
Molecular Weight	436.9 g/mol
XLogP3	1.7
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	7
Rotatable Bond Count	6
Exact Mass	436.1288808 g/mol
Monoisotopic Mass	436.1288808 g/mol
Topological Polar Surface Area	109 Å²
Heavy Atom Count	30
Formal Charge	0
Complexity	586
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

4 Drug and Medication Information

4.1 Drug Indication

Ertugliflozin as a monotherapy is indicated to improve the glycemic control in adult patients with type 2 diabetes. Ertugliflozin, in combination with metformin hydrochloride, is indicated to improve glycemic control in patients with diabetes type 2 who are not controlled on a regimen of ertugliflozin or metformin or in patients who are already treated with both ertugliflozin and metformin. The administration of ertugliflozin in combination with sitagliptin is indicated to improve glycemic control in adult patients with type 2 diabetes when treatment with ertugliflozin and sitagliptin is appropriate. It is pointed out that the use of ertugliflozin has to be an adjunct therapy to the use of diet and exercise. The type 2 diabetes mellitus is characterized by insulin resistance in muscle and liver, which results in the elevation of glucose levels in blood, or by presence of insulin deficiency. The insulin resistance is related to genetic factors, obesity, sedentary lifestyle or/and aging. This increase in the blood glucose can cause severe damage to kidney, eyes and vascular system.

FDA Label

Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:

- as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.

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

5 Pharmacology and Biochemistry

5.1 Pharmacology

Administration of ertugliflozin increases urinary glucose excretion which leads to a negative balance and osmotic diuresis. Thus, this antidiabetic agent has been reported to significantly reduce the body weight and blood pressure of diabetic patients.

5.2 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.)

5.3 ATC Code

A10BK04

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

A10BK04 - Ertugliflozin

5.4 Absorption, Distribution and Excretion

Absorption

Preclinical studies showed that ertugliflozin is well absorbed and had an oral bioavailability of 70-90%. The reported Tmax occurred at 0.5-1.5 hours after dosage. Following oral administration, the Cmax and AUC appeared to be dose proportional.Administration of 15 mg reported values of Cmax and AUC of 268 ng/ml and 1193 ng h/ml respectively.

Route of Elimination

The total recovery of ertugliflozin was 91% and this elimination route is distributed in a ratio of 50% in the urine and 41% in feces. The recovery of the administered dose was achieved approximately 168 hours after initial administration. Urine elimination occurred very rapidly and 80% of the dosage recovered in urine was obtained after 24 hours. The eliminated dose in urine was composed of seven different major metabolites and the unchanged ertugliflozin as a minor metabolite. The elimination rate in feces was depending on the bowel movements of each patient but 98.5% of the eliminated dose in feces was obtained after 168 hours of initial dosage. This eliminated dose was formed mainly by unchanged ertugliflozin and three other minor metabolites.

Volume of Distribution

After oral administration of ertugliflozin, the apparent volume of distribution was reported to be 215.3 L. The steady-state volume of distribution after intravenous administration of etrugliflozin is 85.53 L.

Clearance

The apparent total plasma clearance rate after oral administration of ertugliflozin is 178.7 ml/min and the systemic total plasma clearance after intravenous administration is reported to be 187.2 ml/min.

5.5 Metabolism/Metabolites

In vitro studies showed that the metabolic profile of ertugliflozin in liver microsomes and hepatocytes is formed by reactions of monohydroxylation, O-demethylation and glucuronidation. The metabolism of ertugliflozin is proposed to be formed by 8 different metabolites found in plasma, feces and urine. In plasma, the unchanged form of ertugliflozin was found to be the major component of the administered dose. There were also other six minor metabolites identified in circulating plasma.

5.6 Biological Half-Life

The terminal elimination half-life of ertugliflozin is 11-17 hours.

5.7 Mechanism of Action

As part of a normal process, the glucose from the blood is filtered for excretion and reabsorbed in the glomerulus so less than one percent of this glucose is excreted in the urine. The reabsorption is mediated by the sodium-dependent glucose cotransporter (SGLT), mainly the type 2 which is responsible for 90% of the reabsorbed glucose. Ertugliflozin is a small inhibitor of the SGLT2 and its activity increases glucose excretion, reducing hyperglycemia without the requirement of excessive insulin secretion.

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Biophore India Pharmaceuticals Pvt...

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Shandong Loncom Pharmaceutical

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API Reference Price

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K","customer":"BIOPHORE INDIA PHARMACEUTICALS PVT LTD","customerCountry":"UNITED STATES","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"5000","totalValueFC":"7253.9","currency":"USD","unitRateINR":405256.66666666669,"date":"03-Sep-2024","totalValueINR":"607885","totalValueInUsd":"7253.9","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"3711254","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"425\/3RT, D.NO.7-1-621\/328, SANJEEVAREDDY NAGAR,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731695400,"product":"ERTUGLIFLOZIN L-PYROGLUTAMIC ACID (MFG TAX INV: BPHCI\/24-25\/L341 DT: 13.11.2024,GST NO. 36AADCB0914C1ZC)","address":"227, 2ND FLOOR,DIMPLE ARCADE PREMISES","city":"KANDIVALI EAST","supplier":"AALAKSHYA PHARMA SOLUTIONS LLP","supplierCountry":"INDIA","foreign_port":"LONDON METROPOLITAN","customer":"TO","customerCountry":"UNITED KINGDOM","quantity":"0.40","actualQuantity":"0.4","unit":"KGS","unitRateFc":"25200","totalValueFC":"9951","currency":"USD","unitRateINR":2099360,"date":"16-Nov-2024","totalValueINR":"839744","totalValueInUsd":"9951","indian_port":"Bombay Air","hs_no":"29183090","bill_no":"5660811","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"227, 2ND FLOOR,DIMPLE ARCADE PREMISES, KANDIVALI EAST","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732645800,"product":"ERTUGLIFLOZIN L-PYROGLUTAMIC ACID","address":"227, 2ND FLOOR,DIMPLE ARCADE PREMISES","city":"KANDIVALI EAST","supplier":"AALAKSHYA PHARMA SOLUTIONS LLP","supplierCountry":"INDIA","foreign_port":"LONDON METROPOLITAN","customer":"TO THE ORDER OF","customerCountry":"UNITED KINGDOM","quantity":"0.90","actualQuantity":"0.9","unit":"KGS","unitRateFc":"25200","totalValueFC":"22462","currency":"USD","unitRateINR":2106145,"date":"27-Nov-2024","totalValueINR":"1895530.5","totalValueInUsd":"22462","indian_port":"Bombay Air","hs_no":"29183090","bill_no":"5965870","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"227, 2ND FLOOR,DIMPLE ARCADE PREMISES, KANDIVALI EAST","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732645800,"product":"ERTUGLIFLOZIN L-PYROGLUTAMIC ACID","address":"227, 2ND FLOOR,DIMPLE ARCADE PREMISES","city":"KANDIVALI EAST","supplier":"AALAKSHYA PHARMA SOLUTIONS LLP","supplierCountry":"INDIA","foreign_port":"LONDON METROPOLITAN","customer":"TO THE ORDER OF","customerCountry":"UNITED KINGDOM","quantity":"1.10","actualQuantity":"1.1","unit":"KGS","unitRateFc":"25200","totalValueFC":"27453.6","currency":"USD","unitRateINR":2106145,"date":"27-Nov-2024","totalValueINR":"2316759.5","totalValueInUsd":"27453.6","indian_port":"Bombay Air","hs_no":"29183090","bill_no":"5965870","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"227, 2ND FLOOR,DIMPLE ARCADE PREMISES, KANDIVALI EAST","customerAddress":""}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

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INTERMEDIATES SUPPLIERS

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FDF Dossiers

01

Zenara Pharma

India

BIO Partnering at JPM

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Registration Country : USA

ERTUGLIFLOZIN

Brand Name : ERTUGLIFLOZIN

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

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Application Number : 216842

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02

Zenara Pharma

India

BIO Partnering at JPM

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Regulatory Info :

Registration Country : USA

ERTUGLIFLOZIN

Brand Name : ERTUGLIFLOZIN

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

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Approval Date :

Application Number : 216842

Regulatory Info :

Registration Country : USA

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03

Ascent Innovative Medicines

India

BIO Partnering at JPM

Not Confirmed

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07

Merck & Co

U.S.A

India

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ZENARA

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TE Code :

ERTUGLIFLOZIN

Brand Name : ERTUGLIFLOZIN

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

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Application Number : 216842

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02

ZENARA

India

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RLD :

TE Code :

ERTUGLIFLOZIN

Brand Name : ERTUGLIFLOZIN

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Approval Date :

Application Number : 216842

RX/OTC/DISCN :

RLD :

TE Code :

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ABOUT THIS PAGE

Ertugliflozin L-Pyroglutamic Acid Manufacturers

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

Ertugliflozin L-Pyroglutamic Acid Suppliers

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

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

Ertugliflozin L-Pyroglutamic Acid USDMF

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

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

click here to find a list of Ertugliflozin L-Pyroglutamic Acid suppliers with USDMF on PharmaCompass.

Ertugliflozin L-Pyroglutamic Acid KDMF

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

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

After submitting a Ertugliflozin L-Pyroglutamic Acid 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 Ertugliflozin L-Pyroglutamic Acid API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Ertugliflozin L-Pyroglutamic Acid suppliers with KDMF on PharmaCompass.

Ertugliflozin L-Pyroglutamic Acid 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 Ertugliflozin L-Pyroglutamic Acid as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Ertugliflozin L-Pyroglutamic Acid suppliers with NDC on PharmaCompass.

Ertugliflozin L-Pyroglutamic Acid GMP

Ertugliflozin L-Pyroglutamic Acid 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 Ertugliflozin L-Pyroglutamic Acid 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 Ertugliflozin L-Pyroglutamic Acid GMP manufacturer or Ertugliflozin L-Pyroglutamic Acid GMP API supplier for your needs.

Ertugliflozin L-Pyroglutamic Acid CoA

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

Ertugliflozin L-Pyroglutamic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Ertugliflozin L-Pyroglutamic Acid 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.

Ertugliflozin L-Pyroglutamic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Ertugliflozin L-Pyroglutamic Acid EP), Ertugliflozin L-Pyroglutamic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ertugliflozin L-Pyroglutamic Acid 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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ACTIVE PHARMA INGREDIENTS

11 API Suppliers

7 USDMF

2 KDMF

7 NDC API

7 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

26 FDF Dossiers

14 FDA Orange Book

6 Europe

6 Listed Dossiers

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EXCIPIENTS BY APPLICATIONS

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39 Disintegrants & Superdisintegrants

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24 Controlled & Modified Release

20 Lubricants & Glidants

16 Thickeners and Stabilizers

13 Co-Processed Excipients

10 Film Formers & Plasticizers

10 Solubilizers

8 Chewable & Orodispersible Aids

6 Taste Masking

5 Empty Capsules

5 Coloring Agents

4 Parenteral

4 Vegetarian Capsules

3 API Stability Enhancers

3 Rheology Modifiers

2 Emulsifying Agents

2 Topical

1 Surfactant & Foaming Agents