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    List of Drug Master Files (DMF) of Upadacitinib Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Upadacitinib

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    01 Aurobindo Pharma Limited (1)

    02 Chiral Quest (2)

    03 Crystal Pharmaceutical (1)

    04 Curia (1)

    05 MSN Laboratories (1)

    06 Optimus Pharma (1)

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    01 UPADACITINIB (5)

    02 UPADACITINIB HEMIHYDRATE (1)

    03 UPADACITINIB INTERMEDIATE 1 - TERT-BUTYL (5-TOSYL-5H-PYRROLO[2,3-B]PYRAZIN-2-YL) CARBAMATE (1)

    04 UPADACITINIB INTERMEDIATE 2 - (3R,4S)-BENZYL 3-(2-BROMOACETYL)-4-ETHYLPYRROLIDINE-1-CARBOXYLATE (1)

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    01 China (3)

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    01 Active (8)

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    01 Complete (4)

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    APITORIA PHARMA PRIVATE LTD

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    UPADACITINIB

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    38095
    Active
    2023-02-22
    Complete
    2023-04-24
    2023-02-21
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    CHIRAL QUEST (SUZHOU) CO LTD

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      UPADACITINIB INTERMEDIATE 1 - TERT-BUTYL (5-TOSYL-5H-PYRROLO[2,3-B]PYRAZIN-2-YL) CARBAMATE

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      37868
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      2023-02-20
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      CHIRAL QUEST (SUZHOU) CO LTD

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        UPADACITINIB INTERMEDIATE 2 - (3R,4S)-BENZYL 3-(2-BROMOACETYL)-4-ETHYLPYRROLIDINE-1-CARBOXYLATE

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        37853
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        2023-02-20
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        CRYSTAL PHARMACEUTICAL SUZHOU CO LT...

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          UPADACITINIB

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          38427
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          2023-06-15
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          CURIA SPAIN SAU

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          UPADACITINIB

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          37149
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          2022-06-01
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          2022-08-16
          2022-06-15
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          MSN LABORATORIES PRIVATE LTD

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          UPADACITINIB

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          38153
          Active
          2023-03-26
          Complete
          2023-07-17
          2023-04-25
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          OPTIMUS DRUGS PRIVATE LTD

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          UPADACITINIB HEMIHYDRATE

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          38051
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          2023-02-09
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          HOSTER LABS PRIVATE LTD

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          UPADACITINIB

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          38344
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          2023-05-20
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          2023-07-05
          2023-05-15
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          Looking for 1310726-60-3 / Upadacitinib API manufacturers, exporters & distributors?

          Upadacitinib manufacturers, exporters & distributors 1

          30

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

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

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

          API | Excipient name

          Upadacitinib

          Synonyms

          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

          Cas Number

          1310726-60-3

          Unique Ingredient Identifier (UNII)

          4RA0KN46E0

          About 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.

          Upadacitinib Manufacturers

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

          Upadacitinib Suppliers

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

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

          Upadacitinib USDMF

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

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

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

          Upadacitinib Manufacturers | Traders | Suppliers

          Upadacitinib Manufacturers, Traders, Suppliers 1
          57

          We have 6 companies offering Upadacitinib

          Get in contact with the supplier of your choice:

          1. Aurobindo Pharma Limited
          2. Chiral Quest
          3. Crystal Pharmaceutical
          4. Curia
          5. MSN Laboratories
          6. Optimus Pharma
          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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