Upadacitinib API

Category Pipeline API

Details	Specifications
CAS Number	1310726-60-3
Molecular Formula	C17H19F3N6O
Molecular Weight	380.37 g/mol.
Synonyms	(3S,4R)-3-ethyl-4-(3H-imidazo(1,2-a) pyrrolo(2,3-e) pyrazin-8-yl)-N-(2,2,2- trifluoromethyl) pyrrolidine-1-carboxamide-3-ethyl-4-(3H-imidazo(1%2C2-a)pyrrolo(2%2C3-e)pyrazin-8-yl)-N-(2%2C2%2C2-%20trifluoroethyl)pyrrolidine-1-carboxamide%22%5bCompleteSynonym%5d%20AND%2058557659%5bStandardizedCID%5d)
Chemical Name	(3S)-3-ethyl-4-(3H-imidazo[1,2-a] pyrrolo[2,3-e] pyrazin-8-yl)-N-(2,2,2-tri fluoroethyl) pyrrolidine-1-carboxamide
Therapeutic use	Anus kinase (JAK) inhibitor / Selective JAK1 inhibitor. Immuno modulator / Immunosuppressant that reduces inflammation by blocking the JAK1 enzyme, which is involved in cytokine signaling pathways.
Status	Tech pack available
Background	Upadacitinib (brand name Rinvoq) is a selective, oral Janus kinase (JAK) 1 inhibitor used as an immunosuppressant to treat moderate-to-severe inflammatory diseases, including RA, psoriatic arthritis, atopic dermatitis, Crohn?s disease, and ulcerative colitis. It acts by blocking JAK pathways to reduce inflammation.
Grade	In house
Polymorph	Form C
Storage Temperature	Controlled room temperature (20?C ? 25?C)

Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*

Disclaimer:

The information provided on this webpage is based on the best available knowledge at the time of publication; however, accuracy and completeness are not guaranteed. Product specifications may change without notice. It is the responsibility of the purchaser or user to verify suitability and compliance. This product is intended for research use only and is not approved for human consumption.

Upadacitinib is a selective JAK1 (Janus kinase 1) inhibitor, an oral small-molecule active pharmaceutical ingredient (API) used to treat a range of inflammatory and autoimmune diseases. It works by blocking JAK1 signalling inside cells, which calms the overactive immune response that drives conditions like rheumatoid arthritis. The reference brand is Rinvoq, and upadacitinib is one of the fastest-growing immunology molecules in the world.

Shilpa Pharma is a trusted Upadacitinib API manufacturer and supplier in India, developing this molecule at cGMP-compliant, globally audited facilities. A full technical package is available, and Shilpa supports generic developers who are preparing Upadacitinib programs for launch as patents expire across global markets.

Key specifications

API Name: Upadacitinib
CAS Number: 1310726-60-3
Molecular Formula: C17H19F3N6O
Molecular Weight: 380.37 g/mol
Grade: In-house specification
DMF Status: Technical package available
Polymorph: Form C
Development Stage: Pipeline (tech-pack ready)

As a science-led pharmaceutical API manufacturer in India, Shilpa combines strong process chemistry, tight quality control, and world-class API manufacturing in India to deliver Upadacitinib API that meets demanding international standards.

Upadacitinib API is used to make prescription medicines for autoimmune and inflammatory diseases. Approved uses of upadacitinib-based drugs include rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, Crohn’s disease, and atopic dermatitis.

The molecule is a selective JAK1 inhibitor. In simple terms, it calms an overactive immune system by blocking specific signals in the JAK-STAT pathway that cause inflammation. This helps reduce symptoms such as joint pain, swelling, and skin or gut inflammation, and it has made upadacitinib a leading choice across modern immunology treatment.

For formulation, upadacitinib is developed as an oral extended-release tablet, usually in 15 mg, 30 mg, or 45 mg strengths. Shilpa supplies Upadacitinib API with controlled particle size and a defined solid-state form (Form C) to support stable, reproducible formulation development.

Shilpa can supply Upadacitinib API and related API intermediates for research, development, and regulatory filing, and is ready to scale up through integrated CDMO services for future commercial supply. All supply is aligned with the regulatory and intellectual property position in each market.

Upadacitinib is a potent immunomodulatory molecule, so it must be handled with proper safety controls during manufacturing. Shilpa produces Upadacitinib API under controlled cGMP conditions, using trained personnel, containment systems, and protective measures that protect both product quality and operator safety.

On product safety, Shilpa focuses on strict impurity control and full analytical characterisation. Sensitive analytical methods keep impurities, including any genotoxic impurities, within safe, regulator-approved limits, and every batch is supported by complete quality and stability documentation.

From a clinical reference point, upadacitinib belongs to the JAK inhibitor class, which carries specific prescribing precautions and a boxed warning covering serious infections, blood clots, certain cancers, and major cardiovascular events. This information is shared only as scientific reference for drug developers and is not medical advice.

Shilpa supplies Upadacitinib API strictly to licensed pharmaceutical manufacturers, biotech firms, and authorised partners, with full documentation to support safe and compliant use in finished drug products.

Upadacitinib API pricing is shared on request. Because API cost depends on order volume, development stage, delivery timelines, target market, and regulatory requirements, Shilpa provides a customised quotation for every enquiry rather than a fixed list price.

To receive current Upadacitinib API pricing, availability, and documentation (including the technical package and impurity data), please contact the Shilpa Pharma team. Minimum order quantities apply, and we partner exclusively with pharmaceutical manufacturers, biotech companies, and authorised trading firms.

Email: info@shilpapharma.com | Request a Quote

Choosing the right Upadacitinib API supplier means choosing quality, compliance, and readiness. Here is why global pharmaceutical companies trust Shilpa Pharma:

Globally approved facilities: APIs are developed and manufactured in cGMP-compliant plants approved by USFDA, EU GMP, ANVISA, COFEPRIS, TGA, PMDA, and KFDA.
Development-ready package: A full technical package (tech pack) is available, with a defined Form C polymorph and dossier support for global regulatory filings.
Immunology expertise: Deep experience in complex, high-value small molecules, backed by a strong R&D and process chemistry team.
Patent-ready positioning: Shilpa helps partners prepare Upadacitinib programs so they can launch quickly as patents expire in each market.
End-to-end CDMO services: From route development and process optimisation to scale-up and commercial supply, all under one roof.
High purity and consistency: Strict impurity control and controlled particle size deliver formulation-ready API.

With decades of proven expertise and world-class API manufacturing in India, Shilpa Pharma is the partner of choice for companies developing next-generation immunology therapies. Whether you need an early Upadacitinib API supplier or a long-term manufacturing partner, Shilpa delivers integrity, quality, and global performance.

Partner with a trusted Upadacitinib manufacturer in India. Contact Shilpa Pharma today.