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1. Cp 690,550
2. Cp 690550
3. Cp-690,550
4. Cp-690550
5. Cp690550
6. Tasocitinib
7. Tofacitinib
8. Xeljanz
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
Molecular Weight | 504.5 g/mol |
---|---|
Molecular Formula | C22H28N6O8 |
Hydrogen Bond Donor Count | 5 |
Hydrogen Bond Acceptor Count | 12 |
Rotatable Bond Count | 8 |
Exact Mass | 504.19686187 g/mol |
Monoisotopic Mass | 504.19686187 g/mol |
Topological Polar Surface Area | 221 Ų |
Heavy Atom Count | 36 |
Formal Charge | 0 |
Complexity | 716 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Xeljanz |
PubMed Health | Tofacitinib (By mouth) |
Drug Classes | Antirheumatic, Musculoskeletal Agent |
Drug Label | XELJANZ 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 Ingredient | Tofacitinib citrate |
Dosage Form | Tablet |
Route | Oral |
Strength | eq 5mg base |
Market Status | Prescription |
Company | Pf Prism Cv |
2 of 2 | |
---|---|
Drug Name | Xeljanz |
PubMed Health | Tofacitinib (By mouth) |
Drug Classes | Antirheumatic, Musculoskeletal Agent |
Drug Label | XELJANZ 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 Ingredient | Tofacitinib citrate |
Dosage Form | Tablet |
Route | Oral |
Strength | eq 5mg base |
Market Status | Prescription |
Company | Pf Prism Cv |
Janus Kinase Inhibitors
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Rev. Date :
Pay. Date :
DMF Number : 33332
Submission : 2018-12-21
Status : Active
Type : II
NDC Package Code : 11712-895
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Pay. Date :
DMF Number : 35976
Submission : 2021-05-29
Status : Active
Type : II
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm :
NDC Package Code : 42765-061
Start Marketing Date : 2023-01-01
End Marketing Date : 2025-12-31
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DMF Review : Reviewed
Rev. Date : 2023-12-20
Pay. Date : 2023-11-15
DMF Number : 37164
Submission : 2022-07-29
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-12-30
Written Confirmation Number : WC-0390
Address of the Firm :
NDC Package Code : 71796-050
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Submission : 2018-12-21
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Pay. Date : 2015-09-23
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Registration Number : 305MF10124
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2023-11-29
Latest Date of Registration : 2023-11-29
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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: Immunology Brand Name: BT-600
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: H.C. Wainwright & Co
Deal Size: $3.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 29, 2024
Lead Product(s) : Tofacitinib Citrate
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : H.C. Wainwright & Co
Deal Size : $3.0 million
Deal Type : Public Offering
Biora Therapeutics Prices $3M Direct Offering Under Nasdaq Rules
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 : Other Small Molecule
Upfront Cash : Undisclosed
October 29, 2024
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: Immunology Brand Name: BT-600
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 01, 2024
Lead Product(s) : Tofacitinib Citrate
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Biora Therapeutics Announces Initiation of Phase 1 Clinical Study of BT-600
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 : Other Small Molecule
Upfront Cash : Inapplicable
August 01, 2024
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: Immunology Brand Name: BT-600
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 18, 2024
Lead Product(s) : Tofacitinib Citrate
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Biora Announces Supplemental Data from Phase 1 Trial of BT-600
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 : Other Small Molecule
Upfront Cash : Inapplicable
July 18, 2024
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: Immunology Brand Name: BT-600
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 30, 2024
Lead Product(s) : Tofacitinib Citrate
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Biora Completes Multiple-Ascending Dose Cohorts for BT-600 Clinical Trial
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 : Other Small Molecule
Upfront Cash : Inapplicable
April 30, 2024
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: Immunology Brand Name: BT-600
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 04, 2024
Lead Product(s) : Tofacitinib Citrate
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Biora Therapeutics Achieves Positive Interim Results for BT-600 in NaviCa Platform Trial
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 : Other Small Molecule
Upfront Cash : Inapplicable
April 04, 2024
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: Immunology Brand Name: BT-600
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: H.C. Wainwright & Co
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement March 04, 2024
Lead Product(s) : Tofacitinib Citrate
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : H.C. Wainwright & Co
Deal Size : $6.0 million
Deal Type : Private Placement
Biora Therapeutics Closes $6 Million Registered Direct Offering Priced At-the-Market
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 : Other Small Molecule
Upfront Cash : Undisclosed
March 04, 2024
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: Immunology Brand Name: BT-600
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 26, 2024
Lead Product(s) : Tofacitinib Citrate
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Biora Completes Single-Ascending Dose Cohorts for BT-600 Phase 1 Study
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 : Other Small Molecule
Upfront Cash : Inapplicable
February 26, 2024
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: Immunology Brand Name: BT-600
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 07, 2024
Lead Product(s) : Tofacitinib Citrate
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Biora Therapeutics Announces Positive Clinical Trial Results for BT-600
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 : Other Small Molecule
Upfront Cash : Inapplicable
January 07, 2024
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: Immunology Brand Name: BT-600
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: H.C. Wainwright & Co
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering January 04, 2024
Lead Product(s) : Tofacitinib Citrate
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : H.C. Wainwright & Co
Deal Size : $6.0 million
Deal Type : Public Offering
Biora Announces $6 Million Direct Offering Priced At-the-Market
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 : Other Small Molecule
Upfront Cash : Undisclosed
January 04, 2024
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: Immunology Brand Name: BT-600
Study Phase: IND EnablingProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 29, 2023
Lead Product(s) : Tofacitinib Citrate
Therapeutic Area : Immunology
Highest Development Status : IND Enabling
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
November 29, 2023
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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.
A XELJANZ XR manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of XELJANZ XR, including repackagers and relabelers. The FDA regulates XELJANZ XR manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. XELJANZ XR 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 XR manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A XELJANZ XR supplier is an individual or a company that provides XELJANZ XR active pharmaceutical ingredient (API) or XELJANZ XR finished formulations upon request. The XELJANZ XR suppliers may include XELJANZ XR API manufacturers, exporters, distributors and traders.
click here to find a list of XELJANZ XR suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A XELJANZ XR DMF (Drug Master File) is a document detailing the whole manufacturing process of XELJANZ XR active pharmaceutical ingredient (API) in detail. Different forms of XELJANZ XR DMFs exist exist since differing nations have different regulations, such as XELJANZ XR USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A XELJANZ XR DMF submitted to regulatory agencies in the US is known as a USDMF. XELJANZ XR USDMF includes data on XELJANZ XR's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The XELJANZ XR USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 XR Drug Master File in Japan (XELJANZ XR JDMF) empowers XELJANZ XR 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 XR JDMF during the approval evaluation for pharmaceutical products. At the time of XELJANZ XR JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a XELJANZ XR Drug Master File in Korea (XELJANZ XR KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of XELJANZ XR. The MFDS reviews the XELJANZ XR KDMF as part of the drug registration process and uses the information provided in the XELJANZ XR KDMF to evaluate the safety and efficacy of the drug.
After submitting a XELJANZ XR 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 XR API can apply through the Korea Drug Master File (KDMF).
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A XELJANZ XR written confirmation (XELJANZ XR WC) is an official document issued by a regulatory agency to a XELJANZ XR manufacturer, verifying that the manufacturing facility of a XELJANZ XR active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting XELJANZ XR APIs or XELJANZ XR finished pharmaceutical products to another nation, regulatory agencies frequently require a XELJANZ XR WC (written confirmation) as part of the regulatory process.
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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 XR as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for XELJANZ XR API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture XELJANZ XR as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain XELJANZ XR and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a XELJANZ XR NDC to their finished compounded human drug products, they may choose to do so.
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XELJANZ XR 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 XR 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 XR GMP manufacturer or XELJANZ XR GMP API supplier for your needs.
A XELJANZ XR CoA (Certificate of Analysis) is a formal document that attests to XELJANZ XR's compliance with XELJANZ XR specifications and serves as a tool for batch-level quality control.
XELJANZ XR CoA mostly includes findings from lab analyses of a specific batch. For each XELJANZ XR 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 XR may be tested according to a variety of international standards, such as European Pharmacopoeia (XELJANZ XR EP), XELJANZ XR JP (Japanese Pharmacopeia) and the US Pharmacopoeia (XELJANZ XR USP).