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N-Carbamylglutamate

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

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ACTIVE PHARMA INGREDIENTS

4 API Suppliers, 4 USDMF, 1 JDMF, 1 EU WC, 6 NDC API, 1 Listed Suppliers, $ API Reference Price

4 API Suppliers
4 USDMF
1 JDMF
1 EU WC
6 NDC API
1 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

18 FDF Dossiers, 3 FDA Orange Book, 11 Europe, 1 Canada, 2 South Africa, 1 Listed Dossiers

18 FDF Dossiers
3 FDA Orange Book
11 Europe
1 Canada
2 South Africa
1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 SPI Pharma, 1 DKSH, 2 Faran Shimi Pharmaceutical, 1 Chynops Pharma, 8 Gangwal Healthcare, 1 ACG Worldwide, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 5 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 15 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 3 Microlex e.U, 1 NEWEDGE Overseas, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 8 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 The Dow Chemical Company, 2 Vasa Pharmachem

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42 Coating Systems & Additives, 21 Controlled & Modified Release, 19 Fillers, Diluents & Binders, 18 Disintegrants & Superdisintegrants, 17 Direct Compression, 12 Thickeners and Stabilizers, 12 Granulation, 11 Lubricants & Glidants, 8 Co-Processed Excipients, 6 Taste Masking, 5 Chewable & Orodispersible Aids, 5 Film Formers & Plasticizers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Emulsifying Agents, 3 Rheology Modifiers, 2 Coloring Agents, 1 Surfactant & Foaming Agents, 1 Solubilizers, 1 Topical

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 5 NEWS #PharmaBuzz

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2 DATA COMPILATION #PharmaFlow
5 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 10 Finished Drug Prices

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1 US Medicaid Prescriptions
10 Finished Drug Prices

MARKET PLACE

2 APIs, 1 FDF Dossiers

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2 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Exclusivities

patents
1 US Exclusivities

REF. STANDARDS & IMPURITIES

3 USP , 5 Others

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3 USP
5 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 664,518

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

2DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

7,996,841

Annual Reports (USD Million)

Finished Drug Prices

121 RELATED EXCIPIENT COMPANIES

200EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 1188-38-1, N-carbamyl-l-glutamic acid, (s)-2-ureidopentanedioic acid, Carbaglu, N-carbamylglutamate, N-carbamoyl-l-glutamic acid

Molecular Formula

C₆H₁₀N₂O₅

Molecular Weight

190.15 g/mol

InChI Key

LCQLHJZYVOQKHU-VKHMYHEASA-N

FDA UNII

5L0HB4V1EW

Carglumic Acid is an orally active, synthetic structural analogue of N-acetylglutamate (NAG) and carbamoyl phosphate synthetase 1 (CPS 1) activator, with ammonia lowering activity. NAG, which is formed by the hepatic enzyme N-acetylglutamate synthase (NAGS), is an essential allosteric activator of the enzyme carbamoyl phosphate synthetase 1 (CPS 1). CPS 1 plays an essential role in the urea cycle and converts ammonia into urea. Upon oral administration, carglumic acid can replace NAG in NAGS deficient patients and activates CPS 1, which prevents hyperammonaemia.

Carglumic acid is a Carbamoyl Phosphate Synthetase 1 Activator. The mechanism of action of carglumic acid is as a Carbamoyl Phosphate Synthetase 1 Activator.

1 2D Structure

Carglumic Acid

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(2S)-2-(carbamoylamino)pentanedioic acid

2.1.2 InChI

InChI=1S/C6H10N2O5/c7-6(13)8-3(5(11)12)1-2-4(9)10/h3H,1-2H2,(H,9,10)(H,11,12)(H3,7,8,13)/t3-/m0/s1

2.1.3 InChI Key

LCQLHJZYVOQKHU-VKHMYHEASA-N

2.1.4 Canonical SMILES

C(CC(=O)O)C(C(=O)O)NC(=O)N

2.1.5 Isomeric SMILES

C(CC(=O)O)[C@@H](C(=O)O)NC(=O)N

2.2 Other Identifiers

2.2.1 UNII

5L0HB4V1EW

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Carbamylglutamate

2. N-carbamoyl-l-glutamate

3. N-carbamoylglutamate

4. N-carbamylglutamate

2.3.2 Depositor-Supplied Synonyms

1. 1188-38-1

2. N-carbamyl-l-glutamic Acid

3. (s)-2-ureidopentanedioic Acid

4. Carbaglu

5. N-carbamylglutamate

6. N-carbamoyl-l-glutamic Acid

7. Ureidoglutaric Acid

8. Carbamylglutamic Acid

9. Carbamino-l-glutamic Acid

10. (2s)-2-(carbamoylamino)pentanedioic Acid

11. L-n-carbamoylglutamic Acid

12. N-carbamyl-l-glutamate

13. N-carbamyl-glutamic Acid

14. L-glutamic Acid, N-(aminocarbonyl)-

15. Oe-312

16. 5l0hb4v1ew

17. N-carbamoyl-l-glutamate

18. Chebi:71028

19. N-carbamoylglutamate

20. Oe 312

21. Nsc-760124

22. Oe 312 (laboratory Code Designation)

23. Dsstox_cid_26706

24. Dsstox_rid_81839

25. Dsstox_gsid_46706

26. Carglumic Acid [inn]

27. Carbamylglutamate

28. Carbaglu (tn)

29. Cas-1188-38-1

30. N-(aminocarbonyl)-l-glutamic Acid(carglumic Acid)

31. Unii-5l0hb4v1ew

32. Carglumic Acid [usan:inn]

33. Carglumic-acid

34. Acido Carglumico

35. Acide Carglumique

36. Acidum Carglumicum

37. Glutamic Acid, N-carbamoyl-, L-

38. Ncgc00167549-01

39. Carglumic Acid [mi]

40. Carglumic Acid [jan]

41. Carglumic Acid [usan]

42. Schembl373546

43. Carglumic Acid [vandf]

44. Gtpl7458

45. Carbamyl-l-glutamic Acid

46. Carglumic Acid [mart.]

47. Carglumic Acid [usp-rs]

48. Carglumic Acid [who-dd]

49. Chembl1201780

50. Dtxsid7046706

51. Carglumic Acid (jan/usan/inn)

52. Carglumic Acid [ema Epar]

53. Oe312

54. Bcp16753

55. Hy-b0711

56. Zinc1530283

57. Tox21_112544

58. Carglumic Acid [orange Book]

59. Mfcd00047874

60. S5301

61. Akos010384789

62. N-carbamyl-l-glutamic Acid Crystalline

63. Tox21_112544_1

64. Cs-8208

65. Db06775

66. Nsc 760124

67. Ncgc00274073-01

68. Ds-17934

69. C-1805

70. C05829

71. D07130

72. A804117

73. Q822884

74. J-507608

75. Z1551429737

76. Carglumic Acid, United States Pharmacopeia (usp) Reference Standard

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₆H₁₀N₂O₅
Molecular Weight	190.15 g/mol
XLogP3	-2.4
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	5
Exact Mass	190.05897142 g/mol
Monoisotopic Mass	190.05897142 g/mol
Topological Polar Surface Area	130 Å²
Heavy Atom Count	13
Formal Charge	0
Complexity	227
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	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Carbaglu
PubMed Health	Carglumic acid (By mouth)
Drug Classes	Hyperammonemia Agent
Active Ingredient	Carglumic acid
Dosage Form	Tablet
Route	Oral
Strength	200mg
Market Status	Prescription
Company	Orphan Europe

2 of 2
Drug Name	Carbaglu
PubMed Health	Carglumic acid (By mouth)
Drug Classes	Hyperammonemia Agent
Active Ingredient	Carglumic acid
Dosage Form	Tablet
Route	Oral
Strength	200mg
Market Status	Prescription
Company	Orphan Europe

4.2 Drug Indication

For the treatment of acute and chronic hyperammonaemia in patients with N-acetylglutamate synthase (NAGS) deficiency. This enzyme is an important component of the urea cycle to prevent build up of neurotoxic ammonium in the blood.

FDA Label

Carbaglu is indicated in treatment of:

- hyperammonaemia due to N-acetylglutamate-synthase primary deficiency;

- hyperammonaemia due to isovaleric acidaemia;

- hyperammonaemia due to methymalonic acidaemia;

- hyperammonaemia due to propionic acidaemia.

5 Pharmacology and Biochemistry

5.1 Pharmacology

The median Tmax of Carbaglu was 3 hours (range: 2-4). The daily dose of carglumic acid ranges from 100 to 250 mg/kg and this does are normally adjusted to maintain normal plasma levels of ammonia.

5.2 FDA Pharmacological Classification

5.2.1 Active Moiety

CARGLUMIC ACID

5.2.2 FDA UNII

5L0HB4V1EW

5.2.3 Pharmacological Classes

Carbamoyl Phosphate Synthetase 1 Activators [MoA]; Carbamoyl Phosphate Synthetase 1 Activator [EPC]

5.3 ATC Code

A16AA05

A - Alimentary tract and metabolism

A16 - Other alimentary tract and metabolism products

A16A - Other alimentary tract and metabolism products

A16AA - Amino acids and derivatives

A16AA05 - Carglumic acid

5.4 Absorption, Distribution and Excretion

Absorption

30% bioavailability; Cmax, mean, 100 mg/kg dose = 2.6 g/mL (range of 1.9 - 4.8) Carglumic acid is not subject to to intracellular degradation.

Route of Elimination

Following administration of a single radiolabeled oral dose of 100 mg/kg of body weight, 9% of the dose was excreted unchanged in the urine and up to 60% of the dose was excreted unchanged in the feces.

Volume of Distribution

The apparent volume of distribution was 2657 L (range: 1616-5797).

Clearance

The apparent total clearance was 5.7 L/min (range 3.0-9.7), the renal clearance was 290 mL/min (range 204-445), and the 24-hour urinary excretion was 4.5 % of the dose (range 3.5-7.5).

5.5 Metabolism/Metabolites

A proportion of carglumic acid may be metabolized by the intestinal bacterial flora. The likely end product of carglumic acid metabolism is carbon dioxide, eliminated through the lungs.

5.6 Biological Half-Life

Median values for the terminal half-life was 5.6 hours (range 4.3-9.5).

5.7 Mechanism of Action

Carglumic acid is a synthetic structural analogue of N-acetylglutamate (NAG), which is an essential allosteric activator of the liver enzyme carbamoyl phosphate synthetase 1 (CPS1). CPS1 is found in the mitochondria and is the first enzyme of the urea cycle, which converts ammonia into urea. Carglumic acid acts as a replacement for NAG in NAGS deficiency patients by activating CPS1 but it does not help to regulate the urea cycle.

API SUPPLIERS

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USDMF

01

Novitium Pharma Llc

India

Duphat

Not Confirmed

Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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India

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Digital Content

CARGLUMIC ACID

GDUFA

DMF Review : Complete

Rev. Date : 2019-01-11

Pay. Date : 2018-12-14

DMF Number : 33166

Submission : 2018-12-07

Status : Active

Type : II

02

Dipharma Sa

Switzerland

Duphat

Not Confirmed

03

Procos Spa

Italy

Duphat

Not Confirmed

Virtual Booth

Digital Content

Carglumic Acid IH

Date of Issue : 2024-02-20

Valid Till : 2026-12-06

Written Confirmation Number : WC-0416

Address of the Firm : Plot No. 111 SIDCO Industrial Estate, Kakkalur Thiruvallur-602003 Tamil Nadu, In...

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NDC API

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Listed Suppliers

01

Nuray Chemicals Private Limited

India

Duphat

Not Confirmed

Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

Contact Supplier

India

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Digital Content

Carglumic Acid

About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...

Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in the Indian state of Tamil Nadu. Nuray’s expertise and experience lie in developing the chemistry requirements of the pharmaceutical industry, including the synthesis of NCEs, impurities, metabolites, method development, advanced intermediates and APIs for commercial launch. With its focus on maintaining the highest levels of quality, reliability and transparency, Nuray has emerged as a trusted partner in the global generic market.

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API Reference Price

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D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL ","supplierCountry":"UNITED STATES","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0002","unit":"KGS","unitRateFc":"86900","totalValueFC":"19","currency":"USD","unitRateINR":"7909900","date":"06-Dec-2023","totalValueINR":"1581.98","totalValueInUsd":"19","indian_port":"Hyderabad Air","hs_no":"29241900","bill_no":"9093012","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD, US 21704, UNITED STATES OF AMERICA United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716402600,"product":"CARGLUMIC ACID RELATED COMPOUND A(QTY:1 X 30 MG, VALUE: USD600) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"USP","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00003","unit":"KGS","unitRateFc":"20000000","totalValueFC":"619.8","currency":"USD","unitRateINR":"1722209333","date":"23-May-2024","totalValueINR":"51666.28","totalValueInUsd":"619.8","indian_port":"Hyderabad Air","hs_no":"29332990","bill_no":"3620237","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD, US 21704, UNITED STATES OF AMERICA United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717612200,"product":"CARGLUMIC ACID(QTY:1 X 0.075 G, VALUE: USD 16.08) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHRAMACOPEIAL CONVENTION","supplierCountry":"UNITED STATES","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.000075","unit":"KGS","unitRateFc":"214400","totalValueFC":"16.9","currency":"USD","unitRateINR":"18775333.3","date":"06-Jun-2024","totalValueINR":"1408.15","totalValueInUsd":"16.9","indian_port":"Hyderabad Air","hs_no":"29241900","bill_no":"3860385","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD US 21704SDNF United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717612200,"product":"CARGLUMIC ACID(QTY:1 X 0.45 G, VALUE: USD 31.50) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHRAMACOPEIAL CONVENTION","supplierCountry":"UNITED STATES","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00045","unit":"KGS","unitRateFc":"70000","totalValueFC":"33","currency":"USD","unitRateINR":"6130000","date":"06-Jun-2024","totalValueINR":"2758.5","totalValueInUsd":"33","indian_port":"Hyderabad Air","hs_no":"29241900","bill_no":"3860385","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD US 21704SDNF United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717612200,"product":"CARGLUMIC ACID(QTY:2 X 200 MG, VALUE: USD 273\/EACH) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHRAMACOPEIAL CONVENTION","supplierCountry":"UNITED STATES","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0004","unit":"KGS","unitRateFc":"1365000","totalValueFC":"572.8","currency":"USD","unitRateINR":"119535025","date":"06-Jun-2024","totalValueINR":"47814.01","totalValueInUsd":"572.8","indian_port":"Hyderabad Air","hs_no":"29241900","bill_no":"3860385","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD US 21704SDNF United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717612200,"product":"CARGLUMIC ACID(QTY:4 X 0.75 G, VALUE: USD 43.83\/EACH) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHRAMACOPEIAL CONVENTION","supplierCountry":"UNITED STATES","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.003","unit":"KGS","unitRateFc":"58440","totalValueFC":"183.9","currency":"USD","unitRateINR":"5117676.7","date":"06-Jun-2024","totalValueINR":"15353.03","totalValueInUsd":"183.9","indian_port":"Hyderabad Air","hs_no":"29241900","bill_no":"3860385","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD US 21704SDNF United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717612200,"product":"D-CARGLUMIC ACID(QTY:1 X 30 MG, VALUE: USD 600) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHRAMACOPEIAL CONVENTION","supplierCountry":"UNITED STATES","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00003","unit":"KGS","unitRateFc":"20000000","totalValueFC":"629.4","currency":"USD","unitRateINR":"1751429000","date":"06-Jun-2024","totalValueINR":"52542.87","totalValueInUsd":"629.4","indian_port":"Hyderabad Air","hs_no":"29241900","bill_no":"3860385","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD US 21704SDNF United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"}]

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

01 Novitium Pharma LLC

U.S.A

Duphat

Not Confirmed

02 Recordati Rare Diseases

U.S.A

U.S.A

Duphat

Not Confirmed

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ABOUT THIS PAGE

N-Carbamylglutamate Manufacturers

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

N-Carbamylglutamate Suppliers

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

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

N-Carbamylglutamate USDMF

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

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

click here to find a list of N-Carbamylglutamate suppliers with USDMF on PharmaCompass.

N-Carbamylglutamate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The N-Carbamylglutamate Drug Master File in Japan (N-Carbamylglutamate JDMF) empowers N-Carbamylglutamate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the N-Carbamylglutamate JDMF during the approval evaluation for pharmaceutical products. At the time of N-Carbamylglutamate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of N-Carbamylglutamate suppliers with JDMF on PharmaCompass.

N-Carbamylglutamate WC

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

click here to find a list of N-Carbamylglutamate suppliers with Written Confirmation (WC) on PharmaCompass.

N-Carbamylglutamate 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 N-Carbamylglutamate as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of N-Carbamylglutamate suppliers with NDC on PharmaCompass.

N-Carbamylglutamate GMP

N-Carbamylglutamate 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 N-Carbamylglutamate 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 N-Carbamylglutamate GMP manufacturer or N-Carbamylglutamate GMP API supplier for your needs.

N-Carbamylglutamate CoA

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

N-Carbamylglutamate CoA mostly includes findings from lab analyses of a specific batch. For each N-Carbamylglutamate 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.

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

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ACTIVE PHARMA INGREDIENTS

4 API Suppliers

4 USDMF

1 JDMF

1 EU WC

6 NDC API

1 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

18 FDF Dossiers

3 FDA Orange Book

11 Europe

1 Canada

2 South Africa

1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Minakem

2 SPI Pharma

1 DKSH

2 Faran Shimi Pharmaceutical

1 Chynops Pharma

8 Gangwal Healthcare

1 ACG Worldwide

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

5 BASF

10 Corel Pharma Chem

3 DFE Pharma

6 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

1 Ingredion Pharma Solutions

15 Kerry

3 Kima Chemical

6 Lonza Capsugel

3 Microlex e.U

1 NEWEDGE Overseas

1 Novo Excipients

2 Pharmatrans-Sanaq

2 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

8 Roquette

6 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

9 Sigachi Industries

2 The Dow Chemical Company

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

42 Coating Systems & Additives

21 Controlled & Modified Release

19 Fillers, Diluents & Binders

18 Disintegrants & Superdisintegrants

17 Direct Compression

12 Thickeners and Stabilizers

12 Granulation

11 Lubricants & Glidants

8 Co-Processed Excipients

6 Taste Masking

5 Chewable & Orodispersible Aids

5 Film Formers & Plasticizers

5 Empty Capsules

4 Vegetarian Capsules

4 API Stability Enhancers

3 Emulsifying Agents

3 Rheology Modifiers

2 Coloring Agents

1 Surfactant & Foaming Agents

1 Solubilizers

1 Topical

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow

5 NEWS #PharmaBuzz