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Chemistry

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Also known as: 540737-29-9, Tasocitinib citrate, Xeljanz, Cp-690550 citrate, Tofacitinib (citrate), Tofacitinib (cp-690550) citrate
Molecular Formula
C22H28N6O8
Molecular Weight
504.5  g/mol
InChI Key
SYIKUFDOYJFGBQ-YLAFAASESA-N
FDA UNII
O1FF4DIV0D

Tofacitinib Citrate
1 2D Structure

Tofacitinib Citrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-hydroxypropane-1,2,3-tricarboxylic acid;3-[(3R,4R)-4-methyl-3-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl]-3-oxopropanenitrile
2.1.2 InChI
InChI=1S/C16H20N6O.C6H8O7/c1-11-5-8-22(14(23)3-6-17)9-13(11)21(2)16-12-4-7-18-15(12)19-10-20-16;7-3(8)1-6(13,5(11)12)2-4(9)10/h4,7,10-11,13H,3,5,8-9H2,1-2H3,(H,18,19,20);13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)/t11-,13+;/m1./s1
2.1.3 InChI Key
SYIKUFDOYJFGBQ-YLAFAASESA-N
2.1.4 Canonical SMILES
CC1CCN(CC1N(C)C2=NC=NC3=C2C=CN3)C(=O)CC#N.C(C(=O)O)C(CC(=O)O)(C(=O)O)O
2.1.5 Isomeric SMILES
C[C@@H]1CCN(C[C@@H]1N(C)C2=NC=NC3=C2C=CN3)C(=O)CC#N.C(C(=O)O)C(CC(=O)O)(C(=O)O)O
2.2 Other Identifiers
2.2.1 UNII
O1FF4DIV0D
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Cp 690,550

2. Cp 690550

3. Cp-690,550

4. Cp-690550

5. Cp690550

6. Tasocitinib

7. Tofacitinib

8. Xeljanz

2.3.2 Depositor-Supplied Synonyms

1. 540737-29-9

2. Tasocitinib Citrate

3. Xeljanz

4. Cp-690550 Citrate

5. Tofacitinib (citrate)

6. Tofacitinib (cp-690550) Citrate

7. Xeljanz Xr

8. Tofacitinib Citrate [usan]

9. Cp-690,550-10

10. Tasocitinib Monocitrate

11. 540737-29-9 (citrate)

12. Cp-690550-10

13. Cp 690550 Citrate

14. O1ff4div0d

15. 3-((3r,4r)-4-methyl-3-(methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile 2-hydroxypropane-1,2,3-tricarboxylate

16. Chebi:71197

17. 1-piperidinepropanenitrile, 4-methyl-3-(methyl-7h-pyrrolo(2,3-d)pyrimidin-4-ylamino)- Beta-oxo-, (3r,4r)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

18. 2-hydroxypropane-1,2,3-tricarboxylic Acid; 3-[(3r,4r)-4-methyl-3-[methyl({7h-pyrrolo[2,3-d]pyrimidin-4-yl})amino]piperidin-1-yl]-3-oxopropanenitrile

19. 2-hydroxypropane-1,2,3-tricarboxylic Acid;3-[(3r,4r)-4-methyl-3-[methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl]-3-oxopropanenitrile

20. Unii-o1ff4div0d

21. Mfcd11616529

22. 3-{(3r,4r)-4-methyl-3-[methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl}-3-oxopropanenitrile 2-hydroxypropane-1,2,3-tricarboxylate

23. 3-{(3r,4r)-4-methyl-3-[methyl-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile Citrate Salt

24. 3-{(3r,4r)-4-methyl-3-[methyl-(7h-pyrrolo[2,3-d]pyrimidin-4-yl}-amino]-piperidin-1-yl)-3-oxo-propionitrile Citrate Salt

25. Xeljanz (tn)

26. Tofacitinib Monocitrate

27. Tasocitinib Citric Acid Salt

28. Cep-18770(delanzomib)

29. Mls006010058

30. Schembl1374185

31. Chembl2103743

32. Tofacitinib Citrate (jan/usan)

33. Amy4175

34. Dtxsid80202404

35. Ex-a204

36. Tofacitinib Citrate [jan]

37. C16h20n6o.c6h8o7

38. Tofacitinib Monocitrate [mi]

39. Hy-40354a

40. S5001

41. Tofacitinib Citrate [who-dd]

42. Akos022178222

43. Cp-690550 - Tofacitinib Citrate

44. Tofacitinib Citrate, >=98% (hplc)

45. Ccg-269730

46. Cs-0928

47. Tofacitinib Citrate [orange Book]

48. Ac-25004

49. As-19392

50. Bt163661

51. Smr004701220

52. Cp-690550 Citrate (tofacitinib Citrate)

53. Tofacitinib Citrate (cp-690550 Citrate)

54. Cp 690550-10

55. D09783

56. Q27139435

57. (3r,4r)-4-methyl-3-(methyl-7h-pyrro Lo[2,3-d]pyrimidin-4-ylamino)-beta-oxo-1-piperidinepro Panenitrile Citrate

58. (3r,4r)-4-methyl-3-(methyl-7h-pyrrolo[2,3-d]pyrimidin-4-ylamino)-?-oxo-1-piperidinepropanenitrile Citrate

59. (3r,4r)-4-methyl-3-(methyl-7h-pyrrolo[2,3-d]pyrimidin-4-ylamino)-beta-oxo-1-piperidine Propanenitrile 2-hydroxy-1,2,3-propanetricarboxylate

60. (3r,4r)-4-methyl-3-(methyl-7h-pyrrolo[2,3-d]pyrimidin-4-ylamino)-ss-oxo-1-piperidinepropanenitrile Citrate Salt

61. 1-piperidinepropanenitrile, 4-methyl-3-(methyl-7h-pyrrolo(2,3-d)pyrimidin-4-ylamino)-.beta.-oxo-, (3r,4r)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

62. 1-piperidinepropanenitrile,4-methyl-3-(methyl-7h-pyrrolo[2,3-d]pyrimidin-4-ylamino)-beta-oxo-,(3r,4r)-,2-hydroxy-1,2,3-propanetricarboxylate(1:1)

63. 3-((3r,4r)-4-methyl-3-(methyl(7h-pyrrolo(2,3-d)pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxo-propanenitrile2-hydroxypropane-1,2,3-tricarboxylate (1:1)

64. 3-((3r,4r)-4-methyl-3-(methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile Mono Citrate Salt

65. 3-{(3r,4r)-4-methyl-3-[methyl-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile Mono Citrate Salt

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 504.5 g/mol
Molecular Formula C22H28N6O8
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count12
Rotatable Bond Count8
Exact Mass504.19686187 g/mol
Monoisotopic Mass504.19686187 g/mol
Topological Polar Surface Area221 Ų
Heavy Atom Count36
Formal Charge0
Complexity716
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameXeljanz
PubMed HealthTofacitinib (By mouth)
Drug ClassesAntirheumatic, Musculoskeletal Agent
Drug LabelXELJANZ is the citrate salt of tofacitinib, a JAK inhibitor.Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)--oxo-1-piperidinepropanenitrile, 2-hy...
Active IngredientTofacitinib citrate
Dosage FormTablet
RouteOral
Strengtheq 5mg base
Market StatusPrescription
CompanyPf Prism Cv

2 of 2  
Drug NameXeljanz
PubMed HealthTofacitinib (By mouth)
Drug ClassesAntirheumatic, Musculoskeletal Agent
Drug LabelXELJANZ is the citrate salt of tofacitinib, a JAK inhibitor.Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)--oxo-1-piperidinepropanenitrile, 2-hy...
Active IngredientTofacitinib citrate
Dosage FormTablet
RouteOral
Strengtheq 5mg base
Market StatusPrescription
CompanyPf Prism Cv

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Janus Kinase Inhibitors

Agents that inhibit JANUS KINASES. (See all compounds classified as Janus Kinase Inhibitors.)


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06-Jan-2021
28-Jan-2025
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Drugs in Development

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Details:

The net proceeds will be used to fund the clinical development of its oral biotherapeutics platform, BT-600 (tofacitinib) for the treatment of Ulcerative Colitis.


Lead Product(s): Tofacitinib Citrate

Therapeutic Area: Gastroenterology Brand Name: BT-600

Study Phase: Phase IProduct Type: Small molecule

Sponsor: H.C. Wainwright & Co

Deal Size: $3.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering October 29, 2024

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01

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : The net proceeds will be used to fund the clinical development of its oral biotherapeutics platform, BT-600 (tofacitinib) for the treatment of Ulcerative Colitis.

Product Name : BT-600

Product Type : Small molecule

Upfront Cash : Undisclosed

October 29, 2024

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Details:

BT-600 (tofacitinib) is a drug-device combination program consisting of the orally administered NaviCap™ device which delivers tofacitinib to the colon for treatment of ulcerative colitis.


Lead Product(s): Tofacitinib Citrate

Therapeutic Area: Gastroenterology Brand Name: BT-600

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 18, 2024

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02

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : BT-600 (tofacitinib) is a drug-device combination program consisting of the orally administered NaviCap™ device which delivers tofacitinib to the colon for treatment of ulcerative colitis.

Product Name : BT-600

Product Type : Small molecule

Upfront Cash : Not Applicable

July 18, 2024

blank

Details:

BT-600 (tofacitinib) is a drug-device combination program consisting of the orally administered NaviCap™ device which delivers tofacitinib to the colon for treatment of ulcerative colitis.


Lead Product(s): Tofacitinib Citrate

Therapeutic Area: Gastroenterology Brand Name: BT-600

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 01, 2024

blank

03

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : BT-600 (tofacitinib) is a drug-device combination program consisting of the orally administered NaviCap™ device which delivers tofacitinib to the colon for treatment of ulcerative colitis.

Product Name : BT-600

Product Type : Small molecule

Upfront Cash : Not Applicable

July 01, 2024

blank

Details:

BT-600 (tofacitinib) is a drug-device combination using the NaviCap™ device to deliver a liquid formulation of tofacitinib to the colon, aimed at treating moderate to severe ulcerative colitis.


Lead Product(s): Tofacitinib Citrate

Therapeutic Area: Gastroenterology Brand Name: BT-600

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 30, 2024

blank

04

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : BT-600 (tofacitinib) is a drug-device combination using the NaviCap™ device to deliver a liquid formulation of tofacitinib to the colon, aimed at treating moderate to severe ulcerative colitis.

Product Name : BT-600

Product Type : Small molecule

Upfront Cash : Not Applicable

April 30, 2024

blank

Details:

BT-600 is a drug device combination containing liquid formulation of tofacitinib (JAK inhibitor). It is being evaluated for the treatment of ulcerative colitis


Lead Product(s): Tofacitinib Citrate

Therapeutic Area: Gastroenterology Brand Name: BT-600

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 04, 2024

blank

05

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : BT-600 is a drug device combination containing liquid formulation of tofacitinib (JAK inhibitor). It is being evaluated for the treatment of ulcerative colitis

Product Name : BT-600

Product Type : Small molecule

Upfront Cash : Not Applicable

April 04, 2024

blank

Details:

Biora intends to use the net proceeds from this offering to support its operations, complete its ongoing BT-600 (tofacitinib) clinical trial for the treatment of moderate to severe ulcerative colitis.


Lead Product(s): Tofacitinib Citrate

Therapeutic Area: Gastroenterology Brand Name: BT-600

Study Phase: Phase IProduct Type: Small molecule

Sponsor: H.C. Wainwright & Co

Deal Size: $6.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement April 03, 2024

blank

06

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : Biora intends to use the net proceeds from this offering to support its operations, complete its ongoing BT-600 (tofacitinib) clinical trial for the treatment of moderate to severe ulcerative colitis.

Product Name : BT-600

Product Type : Small molecule

Upfront Cash : Undisclosed

April 03, 2024

blank

Details:

Biora intends to complete its clinical trial of BT-600, a drug-device combination delivering tofacitinib to the colon for treating moderate to severe ulcerative colitis.


Lead Product(s): Tofacitinib Citrate

Therapeutic Area: Gastroenterology Brand Name: BT-600

Study Phase: Phase IProduct Type: Small molecule

Sponsor: H.C. Wainwright & Co

Deal Size: $6.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering April 01, 2024

blank

07

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : Biora intends to complete its clinical trial of BT-600, a drug-device combination delivering tofacitinib to the colon for treating moderate to severe ulcerative colitis.

Product Name : BT-600

Product Type : Small molecule

Upfront Cash : Undisclosed

April 01, 2024

blank

Details:

BT-600 (tofacitinib) is a drug-device combination using the NaviCap™ device to deliver a unique liquid formulation of tofacitinib to the colon, aimed at treating moderate to severe ulcerative colitis.


Lead Product(s): Tofacitinib Citrate

Therapeutic Area: Gastroenterology Brand Name: BT-600

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 26, 2024

blank

08

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : BT-600 (tofacitinib) is a drug-device combination using the NaviCap™ device to deliver a unique liquid formulation of tofacitinib to the colon, aimed at treating moderate to severe ulcerative colitis.

Product Name : BT-600

Product Type : Small molecule

Upfront Cash : Not Applicable

February 26, 2024

blank

Details:

BT-600 (tofacitinib) is a drug-device combination using the NaviCap™ device to deliver a liquid formulation of tofacitinib to the colon, aimed at treating moderate to severe ulcerative colitis.


Lead Product(s): Tofacitinib Citrate

Therapeutic Area: Gastroenterology Brand Name: BT-600

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 08, 2024

blank

09

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : BT-600 (tofacitinib) is a drug-device combination using the NaviCap™ device to deliver a liquid formulation of tofacitinib to the colon, aimed at treating moderate to severe ulcerative colitis.

Product Name : BT-600

Product Type : Small molecule

Upfront Cash : Not Applicable

January 08, 2024

blank

Details:

BT-600 (tofacitinib) is a drug/device combination designed to use Biora’s NaviCap™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib. It is being evaluated for the treatment of Ulcerative Colitis.


Lead Product(s): Tofacitinib Citrate

Therapeutic Area: Gastroenterology Brand Name: BT-600

Study Phase: IND EnablingProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 29, 2023

blank

10

World ADC London
Not Confirmed
World ADC London
Not Confirmed

Details : BT-600 (tofacitinib) is a drug/device combination designed to use Biora’s NaviCap™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib. It is being evaluated for the treatment of Ulcerative Colitis.

Product Name : BT-600

Product Type : Small molecule

Upfront Cash : Not Applicable

November 29, 2023

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ABOUT THIS PAGE

Looking for 540737-29-9 / Tofacitinib Citrate API manufacturers, exporters & distributors?

Tofacitinib Citrate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Tofacitinib Citrate 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 Tofacitinib Citrate manufacturer or Tofacitinib Citrate supplier for your needs.

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

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

API | Excipient name

Tofacitinib Citrate

Synonyms

540737-29-9, Tasocitinib citrate, Xeljanz, Cp-690550 citrate, Tofacitinib (citrate), Tofacitinib (cp-690550) citrate

Cas Number

540737-29-9

Unique Ingredient Identifier (UNII)

O1FF4DIV0D

Xeljanz Manufacturers

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

Xeljanz Suppliers

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

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

Xeljanz USDMF

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

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

click here to find a list of Xeljanz suppliers with USDMF on PharmaCompass.

Xeljanz 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 Xeljanz Drug Master File in Japan (Xeljanz JDMF) empowers Xeljanz 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 Xeljanz JDMF during the approval evaluation for pharmaceutical products. At the time of Xeljanz 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 Xeljanz suppliers with JDMF on PharmaCompass.

Xeljanz KDMF

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

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

After submitting a Xeljanz 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 Xeljanz API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Xeljanz suppliers with KDMF on PharmaCompass.

Xeljanz WC

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

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

Xeljanz 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 Xeljanz as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Xeljanz suppliers with NDC on PharmaCompass.

Xeljanz GMP

Xeljanz 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 Xeljanz 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 Xeljanz GMP manufacturer or Xeljanz GMP API supplier for your needs.

Xeljanz CoA

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

Xeljanz CoA mostly includes findings from lab analyses of a specific batch. For each Xeljanz 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.

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