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Looking for 1310726-60-3 / Upadacitinib API manufacturers, exporters & distributors?

Upadacitinib manufacturers, exporters & distributors 1


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



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

Cas Number


Unique Ingredient Identifier (UNII)


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 KDMF

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

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

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

CLICK HERE to find a list of Upadacitinib suppliers with KDMF on PharmaCompass.

Upadacitinib 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 Upadacitinib as an active pharmaceutical ingredient (API).

Finished drug products

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

CLICK HERE to find a list of Upadacitinib suppliers with NDC on PharmaCompass.

Upadacitinib GMP

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

Upadacitinib CoA

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

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

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