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ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 9 USDMF, 5 NDC API, 22 Listed Suppliers, $ API Reference Price

27 API Suppliers
9 USDMF
5 NDC API
22 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

64 Drugs in Development

64 Drugs in Development

INTERMEDIATES

29 Intermediates Suppliers

29 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

33 FDF Dossiers, 4 FDA Orange Book, 1 Europe, 3 Canada, 24 Australia, 1 South Africa

33 FDF Dossiers
4 FDA Orange Book
1 Europe
3 Canada
24 Australia
1 South Africa

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7 DATA COMPILATION #PharmaFlow, 2 STOCK RECAP #PipelineProspector, 133 NEWS #PharmaBuzz

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2 STOCK RECAP #PipelineProspector
133 NEWS #PharmaBuzz

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1 US Medicaid Prescriptions, 1 Finished Drug Prices, 5 Annual Reports

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1 US Medicaid Prescriptions
1 Finished Drug Prices
5 Annual Reports

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5 APIs, 2 FDF Dossiers

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5 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

94 US Patents, 25 US Exclusivities

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94 US Patents
25 US Exclusivities

Zhejiang Hengkang

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ACTIVE PHARMA INGREDIENTS

27

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9

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22

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$ 85,711

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5

API

2

FDF

29INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

33

FDF Dossiers

4

FDA Orange Book

FDA (Orange Book)

1

Europe

3

Canada

24

Australia

1

South Africa

0

Listed Dossiers

64DRUGS IN DEVELOPMENT

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94

US Patents

25

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

7

Data Compilation #PharmaFlow

2

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

133

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

622,108,917

Annual Reports (USD Million)

8,920

Finished Drug Prices

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Chemistry

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Also known as: 1310726-60-3, Abt-494, Rinvoq, Upadacitinib anhydrous, 4ra0kn46e0, (3s,4r)-3-ethyl-4-(1,5,7,10-tetrazatricyclo[7.3.0.02,6]dodeca-2(6),3,7,9,11-pentaen-12-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide

Molecular Formula

C₁₇H₁₉F₃N₆O

Molecular Weight

380.4 g/mol

InChI Key

WYQFJHHDOKWSHR-MNOVXSKESA-N

FDA UNII

4RA0KN46E0

Upadacitinib

Upadacitinib is an oral Janus kinase (JAK)1-selective inhibitor and a disease-modifying antirheumatic drug (DMARD) used in the treatment of rheumatoid arthritis to slow down disease progression. Rheumatoid arthritis is a chronic autoimmune inflammatory disease affecting the peripheral joints. It is characterized by synovial inflammation and hyperplasia, autoantibody production, cartilage damage and bone destruction, leading to co-morbidities. Despite a variety of therapeutic agents available for treatment, up to 40% of the patients do not respond to current therapies, including biological therapies. The etiology of the disease is mostly unknown; however, the role of JAK as a driver of immune-mediated conditions was discovered, leading to the use of JAK as therapeutic targets for rheumatoid arthritis. To reduce dose-related toxicity (as seen with some pan-JAK inhibitors) without significantly affecting efficacy, more selective JAK1 inhibitors, upadacitinib and [filgotinib], were developed. The FDA approved Upadacitinib in August 2019 for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, it was additionally approved by the European Commission for the same indication in patients with inadequate response or intolerance to one or more DMARDs and can be used as monotherapy or in combination with methotrexate. Upadacitinib is marketed under the brand name RINVOQ for oral administration. It is currently being investigated in several clinical trials assessing its therapeutic effectiveness in other inflammatory diseases, such as psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and atopic dermatitis.

1 2D Structure

Upadacitinib

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(3S,4R)-3-ethyl-4-(1,5,7,10-tetrazatricyclo[7.3.0.02,6]dodeca-2(6),3,7,9,11-pentaen-12-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide

2.1.2 InChI

InChI=1S/C17H19F3N6O/c1-2-10-7-25(16(27)24-9-17(18,19)20)8-11(10)13-5-22-14-6-23-15-12(26(13)14)3-4-21-15/h3-6,10-11,21H,2,7-9H2,1H3,(H,24,27)/t10-,11+/m1/s1

2.1.3 InChI Key

WYQFJHHDOKWSHR-MNOVXSKESA-N

2.1.4 Canonical SMILES

CCC1CN(CC1C2=CN=C3N2C4=C(NC=C4)N=C3)C(=O)NCC(F)(F)F

2.1.5 Isomeric SMILES

CC[C@@H]1CN(C[C@@H]1C2=CN=C3N2C4=C(NC=C4)N=C3)C(=O)NCC(F)(F)F

2.2 Other Identifiers

2.2.1 UNII

4RA0KN46E0

2.3 Synonyms

2.3.1 MeSH Synonyms

1. (3s,4r)-3-ethyl-4-(3h-imidazo(1,2-a)pyrrolo(2,3-e)pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)-1-pyrrolidinecarboxamide

2. Abt-494

3. Rinvoq

2.3.2 Depositor-Supplied Synonyms

1. 1310726-60-3

2. Abt-494

3. Rinvoq

4. Upadacitinib Anhydrous

5. 4ra0kn46e0

6. (3s,4r)-3-ethyl-4-(1,5,7,10-tetrazatricyclo[7.3.0.02,6]dodeca-2(6),3,7,9,11-pentaen-12-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide

7. (3s,4r)-3-ethyl-4-(3h-imidazo(1,2-a)pyrrolo(2,3-e)pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)-1-pyrrolidinecarboxamide

8. (3s,4r)-3-ethyl-4-(3h-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide

9. 1-pyrrolidinecarboxamide, 3-ethyl-4-(3h-imidazo(1,2-a)pyrrolo(2,3-e)pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)-, (3s,4r)-

10. Mfcd30502663

11. Upadacitinib [usan]

12. Upadacitinib [mi]

13. Upadacitinib, Abt-494

14. Upadacitinib (usan/inn)

15. Upadacitinib [inn]

16. Upadacitinib [usan:inn]

17. Upadacitinib (abt-494)

18. Unii-4ra0kn46e0

19. Upadacitinib [who-dd]

20. Gtpl9246

21. Schembl9991056

22. Chembl3622821

23. Abt 494

24. Dtxsid901027919

25. Upadacitinib [orange Book]

26. Amy16528

27. Bcp19011

28. Ex-a1628

29. Bdbm50503287

30. S8162

31. Cs-6150

32. Db15091

33. Abbv-599 Component Upadacitinib

34. Abt494;abt-494;abt 494

35. Ncgc00588874-01

36. Ac-30326

37. As-56379

38. Hy-19569

39. Upadacitinib Component Of Abbv-599

40. J3.590.729g

41. C72237

42. D10994

43. Q27074125

44. (3s,4r)-3-ethyl-4-(3h-imidazo(1,2-a)pyrrolo(2,3-e)pyrazin- 8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide Tyrosine Kinase Inhibitor

45. (3s,4r)-3-ethyl-4-(3h-imidazo(1,2-a)pyrrolo(2,3-e)pyrazin-8-yl)-n-(2,2,2- Trifluoroethyl)pyrrolidine-1-carboxamide

46. Rel-(-)-(3s,4r)-3-ethyl-4-(3h-imidazo(1,2-a)pyrrolo(2,3-e)pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide

2.4 Create Date

2012-08-19

3 Chemical and Physical Properties

Molecular Formula	C₁₇H₁₉F₃N₆O
Molecular Weight	380.4 g/mol
XLogP3	2.7
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	3
Exact Mass	380.15724374 g/mol
Monoisotopic Mass	380.15724374 g/mol
Topological Polar Surface Area	78.3 Å²
Heavy Atom Count	27
Formal Charge	0
Complexity	561
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	1

4 Drug and Medication Information

4.1 Drug Indication

Upadacitinib is indicated for the treatment of moderately to severely active rheumatoid arthritis or active psoriatic arthritis in adult patients who have had an inadequate response or intolerance to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate or TNF blockers. For these indications, upadacitinib may be used as monotherapy or in combination with methotrexate. Upadacitinib is also indicated for the treatment of active ankylosing spondylitis in adult patients who have an inadequate response to conventional therapy and for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy. Combining upadacitinib with other JAK inhibitors, biologic DMARDs, or other potent immunosuppressive agents is not recommended.

FDA Label

Rheumatoid arthritis

RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.

Psoriatic arthritis

RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Axial spondyloarthritis

Non-radiographic axial spondyloarthritis (nr-axSpA)

RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis )

RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

Atopic dermatitis

RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

Ulcerative colitis

RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Treatment of ulcerative colitis

Treatment of Crohn's disease

Treatment of vasculitides

Treatment of vasculitides

Treatment of atopic dermatitis

Treatment of chronic idiopathic arthritis (including rheumatoid arthritis , psoriatic arthritis , spondyloarthritis and juvenile idiopathic arthritis )

5 Pharmacology and Biochemistry

5.1 Pharmacology

Upadacitinib is a DMARD that works by inhibiting the Janus Kinases (JAKs), which are essential downstream cell signalling mediators of pro-inflammatory cytokines. It is believed that these pro-inflammatory cytokines play a role in many autoimmune inflammatory conditions, such as rheumatoid arthritis. In clinical trials, upadacitinib decreased the activity of pro-inflammatory interleukins, transiently increased the levels of lymphocytes, and insignificantly decreased the levels of immunoglobulins from the baseline.

5.2 MeSH Pharmacological Classification

Antirheumatic Agents

Drugs that are used to treat RHEUMATOID ARTHRITIS. (See all compounds classified as Antirheumatic Agents.)

Janus Kinase Inhibitors

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

5.3 ATC Code

L04AA

L - Antineoplastic and immunomodulating agents

L04 - Immunosuppressants

L04A - Immunosuppressants

L04AA - Selective immunosuppressants

L04AA44 - Upadacitinib

5.4 Absorption, Distribution and Excretion

Absorption

Upadacitinib displays a dose-proportional pharmacokinetic profile over the therapeutic dose range. Following oral administration, the median time to reach Cmax (Tmax) ranges from 2 to 4 hours. The steady-state plasma concentrations of upadacitinib are reached within 4 days following multiple once-daily administrations, with minimal accumulation. Food intake has no clinically relevant effect on the AUC, Cmax, and Cmin of upadacitinib from the extended-release formulation.

Route of Elimination

Following administration of a single radio-labelled dose from the immediate-release formulation, approximately 53% of the total dose was excreted in the feces where 38% of the excreted dose was an unchanged parent drug. About 43% of the total dose was excreted in the urine, where 24% of that dose was in the unchanged parent drug form. Approximately 34% of the total dose of upadacitinib dose was excreted as metabolites.

Volume of Distribution

The volume of distribution of upadacitinib in a patient with rheumatoid arthritis and a body weight of 74 kg is estimated to be 224 L following oral administration of an extended-release formula. In a pharmacokinetic study consisting of healthy volunteers receiving the extended-release formulation, the steady-state volume of distribution was 294 L. Upadacitinib partitions similarly between plasma and blood cellular components with a blood to plasma ratio of 1.0.

Clearance

The apparent oral clearance of upadacitinib in healthy volunteers receiving the extended-release formulation was 53.7 L/h.

5.5 Metabolism/Metabolites

Upadacitinib predominantly undergoes CYP3A4-mediated metabolism; however, upadacitinib is a nonsensitive substrate of CYP3A4. It is also metabolized by CYP2D6 to a lesser extent. In a human radio-labelled study, about 79% of the total plasma radioactivity accounted for the parent drug, and about 13% of the total plasma radioactivity accounted for the main metabolite produced from mono-oxidation, followed by glucuronidation. There are no known active metabolites of upadacitinib.

5.6 Biological Half-Life

The mean terminal elimination half-life of upadacitinib ranged from 8 to 14 hours following administration of the extended-release formulation. In clinical trials, approximately 90% of upadacitinib in the systemic circulation was eliminated within 24 hours of dosing.

5.7 Mechanism of Action

Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease that involves the interplay of several mediators, including the immune cells (mainly T- and B-lymphocytes) and pro-inflammatory cytokines, such as the tumour necrosis factor (TNF), transforming growth factor (TGF), and interleukin 6 (IL-6). The Janus Kinase (JAK) family plays an essential role in the normal physiological functions (such as erythropoiesis), but also the signalling of pro-inflammatory cytokines that are implicated in many immune-mediated diseases. The JAK family consists of four isoforms (JAK1, JAK2, JAK3, and Tyrosine Kinase 2) that each interacts with different cytokine receptors and uniquely associates with the intracellular domains of Type I/II cytokine receptors. JAK1 is primarily involved in the signalling transduction pathways of IL-6, IFN and the common -chain cytokines, including IL-2 and IL-15. IL-6 has been closely studied in particular, as it is a major cytokine involved in B- and T-cell differentiation and the acute phase response in inflammation. Upon interaction of cytokines with their cytokine receptors, the JAKs mediate the JAK-STAT signal transduction pathway in response to receptor activation. JAKs are tyrosine kinases that cause phosphorylation of several proteins, including cytokine receptors and JAKs themselves. Phosphorylation of JAKs promotes the phosphorylation and activation of the signalling molecules called STATs, leading to their nuclear translocation, binding to DNA promoters, and target gene transcription. JAK1-mediated signalling pathways ultimately promote pro-inflammatory events, such as increased proliferation and survival of immune cells, T cell differentiation, and macrophage activation. Upadacitinib is a selective JAK1 inhibitor that has a negligible effect on JAK3, leading to an improved drug safety profile. Upadacitinib blocks the cellular processes that contribute to the inflammatory conditions in rheumatoid arthritis. In human leukocytes cellular assays, upadacitinib inhibited JAK1/3-induced phosphorylation of STAT3/5 mediated by IL-6/7.

API SUPPLIERS

01

Zhejiang Hengkang Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.

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Metrochem API Private Limited

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Egis Pharmaceuticals PLC

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Shandong Loncom Pharmaceutical

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Crystal Pharmaceutical

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UPADACITINIB

NDC Package Code : 68513-2320

Start Marketing Date : 2024-06-27

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Aurobindo Pharma Limited

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Zhejiang Hengkang Pharmaceutical

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Upadacitinib

About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...

Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming to global API standards, along with professional R&D and marketing teams, Hengkang’s operations span major pharmaceutical markets such as China, Europe, the CIS region, Japan, and South Korea. Hengkang has established long-term and stable relationships with nearly 70 countries overseas and hundreds of domestic enterprises.

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About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...

Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout the entire API life cycle, from product development through sales. Transo-Pharm serves as a sourcing and regulatory marketing agent for API manufacturers. It aids clients in establishing DMFs and provides GMP consulting. With a dedicated regulatory department, a warehouse, proprietary IPs for API processes, and partnerships with laboratories, Transo-Pharm offers a wide range of services. It operates from its offices in Shanghai, Hong Kong, Singapore, and the US.

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Metrochem API Private Limited

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Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer

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Egis Pharmaceuticals PLC

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

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

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Shandong Chenghui Shuangda Pharmace...

China

Shuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.

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China

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Upadacitinib

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

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

Shandong Chenghui Shuangda Pharmaceutical

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06

Jinan Tantu Chemicals

China

Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

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China

Digital Content

Upadacitinib

About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...

Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include customized R&D as well as the production of small molecule pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) for both international and domestic pharmaceutical firms. Our capabilities span from laboratory-scale kilograms to commercial ton-scale production. Additionally, we are committed to independent research and development, as well as the production and sales of high-end pharmaceutical intermediates and API products.

Jinan Tantu Chemicals

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07

Shandong Loncom Pharmaceutical

China

Antibody Engineering

Not Confirmed

Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

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China

Digital Content

Upadacitinib

About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...

Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development Zone, Shandong Province, Shandong Loncom has operational API pilot tests and production bases adhering to international standards. With 13 production lines dedicated to oral solid preparations, oral liquid preparations and API, it is actively expanding its preparation workshops for small-volume injections, soft capsules, eye drops, topical medicines and innovative drug R&D centres.

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08

TAPI Technology & API Services

Israel

CPhI WW Frankfurt

TAPI offers customized CDMO Solutions for API development and manufacturing services.

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Israel

Digital Content

Upadacitinib

About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.

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09

Aurobindo Pharma Limited

India

Antibody Engineering

Not Confirmed

10

Hebi Xinhe Pharmaceutical

China

Antibody Engineering

Not Confirmed

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SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696962600,"product":"UPADACITINIB INTERMEDIATE","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"ZHEJIANG SHINDAI CHEMICALS CO .,LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"LEE PHARMA","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.3","unit":"GMS","unitRateFc":"18330","totalValueFC":"5559.8","currency":"USD","unitRateINR":"1542469.5","date":"11-Oct-2023","totalValueINR":"462740.85","totalValueInUsd":"5559.8","indian_port":"Madras Air","hs_no":"29349990","bill_no":"8248840","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"24A ,NO .25 JUYE ROAD,BINJIANGDISTRICT ,HANGZHOU CHINA,SDNF CN","customerAddress":"SYNO.257 258\/1, DNO.11-6\/56,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701714600,"product":"LUT-7 ACTIVE PHARMACEUTICALS INGREDIENTS (UPADACITINIB) (CASNUMBER 1310726-60-3 BATCH V2994\/0 22171)","address":"SANDOZ HOUSE","city":"MUMBAI ,MAHARASHTRA","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"SANDOZ B2B","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.025","unit":"KGS","unitRateFc":"104000","totalValueFC":"2897.9","currency":"EUR","unitRateINR":"9649347.6","date":"05-Dec-2023","totalValueINR":"241233.69","totalValueInUsd":"2897.9","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"9082299","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"PARQUE TECHNOLOGICO DE BOECILLOPARCELA 105 47151 BOECILLOVALLADOLID SPAIN","customerAddress":"SANDOZ HOUSE"}]

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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FDA Orange Book

01

ABBVIE

U.S.A

Antibody Engineering

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

UPADACITINIB

Brand Name : RINVOQ

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 15MG

Approval Date : 2019-08-16

Application Number : 211675

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

ABBVIE

U.S.A

Antibody Engineering

Not Confirmed

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RLD : Yes

TE Code :

UPADACITINIB

Brand Name : RINVOQ

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 30MG

Approval Date : 2022-01-14

Application Number : 211675

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Abbvie Company Banner

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Corporate PDF

03

ABBVIE

U.S.A

Antibody Engineering

Not Confirmed

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RLD : Yes

TE Code :

UPADACITINIB

Brand Name : RINVOQ

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 45MG

Approval Date : 2022-03-16

Application Number : 211675

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

ABBVIE

U.S.A

Antibody Engineering

Not Confirmed

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RLD : Yes

TE Code :

UPADACITINIB

Brand Name : RINVOQ LQ

Dosage Form : SOLUTION;ORAL

Dosage Strength : 1MG/ML

Approval Date : 2024-04-26

Application Number : 218347

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Europe

01

AbbVie AG

U.S.A

Antibody Engineering

Not Confirmed

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Regulatory Info :

Registration Country : Switzerland

Upadacitinibum

Brand Name : RINVOQ

Dosage Form : Ret Tabl

Dosage Strength : 15mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Canada

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US Medicaid Prescriptions

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Finished Drug Prices

01

Brand Name : RINVOQ

U.S.A

Cosmoprof India

Not Confirmed

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RX/OTC/DISCN : Class B

Upadacitinib

Dosage Form : Ret Tabl

Dosage Strength : 15mg

Price Per Pack (Euro) : 786.97

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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Annual Reports

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Market Place

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APIs

Upadacitinib (60 g) API needed in India [ENA21176]

A CRO that provides formulation and analytical development services for OSDs, parenteral and liquid orals is looking for suppliers of Upadacitinib (60 g) API for development purposes. The suppliers must support this enquiry with USDMF & CoA.

Reply

20 Nov 2024

Upadacitinib (100 kg) API needed in China [ENA19530]

A company that focuses on manufacturing and development of various intermediates is looking for suppliers of Upadacitinib (100 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.

Reply

18 May 2024

Upadacitinib (5 g - 10 g) API needed in India [ENA16837]

A CRO that focuses on the development of impurities and intermediates is looking for suppliers of Upadacitinib (5 g - 10 g) API for development purposes. The suppliers must support this enquiry with CoA.

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07 Apr 2023

Upadacitinib (50 g) API needed in Egypt [ENA15718]

A company that focuses on the development and manufacturing of OSDs, semi-solids & oral liquids is looking for suppliers of Upadacitinib (50 g) API for development purposes. The suppliers must support this enquiry with GMP & CoA.

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02 Dec 2022

Upadacitinib API needed in the United States [ENA11566]

A company that deals in the research & development of special pharmaceutical products with various advanced drug delivery systems in areas of immunology, cardiology, CNS, blood system, metabolism, digestive system, anti-infective, and anti-tumor therapeutic fields is looking for suppliers of Upadacitinib API for development purpose.

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05 Oct 2021

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