Buy Tofacitinib Citrate Manufacturer & Supplier

Molecular Mechanism & Chiral Integrity

Tofacitinib Citrate (Chemical Formula: C₁₆H₂₀N₆O · C₆H₈O₇, MW: 504.49 g/mol) is a potent, selective small-molecule oral inhibitor of the Janus Kinase (JAK) family. It specifically targets JAK1 and JAK3 enzymes, effectively blocking the signaling trans-phosphorylation of Signal Transducer and Activator of Transcription (STAT) proteins. This targeted pathway downstream suppresses critical pro-inflammatory cytokines including IL-2, IL-4, IL-7, IL-9, IL-15, and IL-21.

From a synthetic chemistry perspective, achieving absolute chiral resolution at the 3R,4R pyrrolo[2,3-d]pyrimidine backbone is paramount. Gentolex utilizes proprietary asymmetric enzymatic reduction and diastereomeric salt crystallization techniques to guarantee an enantiomeric excess (e.e.) exceeding 99.8%, effectively eliminating unwanted stereoisomers that compromise therapeutic safety profiles.

Polymorphism & Particle Size Distribution (PSD)

The bioavailability and dissolution profile of Tofacitinib Citrate oral solid formulations (FDF) depend directly on the control of crystal polymorphism. Our dedicated API crystallization suites produce pure Polymorphic Form I consistently, validated through Powder X-Ray Diffraction (PXRD) and Differential Scanning Calorimetry (DSC).

To cater to diverse drug release systems—including immediate-release, modified-release, and topical dermatological formulations—we offer customized micronization services using fluid energy jet milling. Particle size distributions can be tailored to exact specifications (e.g., D90 < 10 μm, D50 < 3 μm) with controlled specific surface area (SSA) parameters to optimize wet-granulation and direct-compression tableting processes.

Expanding Therapeutic Indications

Originally approved for moderate to severe Rheumatoid Arthritis (RA), Tofacitinib Citrate has expanded into vast global therapeutic markets including Psoriatic Arthritis, Ulcerative Colitis (UC), Juvenile Idiopathic Arthritis (JIA), and Ankylosing Spondylitis. Furthermore, ongoing clinical investigations into topical alopecia areata and vitiligo solutions are exponentially driving demand for premium micronized raw material APIs.

Supply Chain Security & Risk Mitigation

Global pharmaceutical procurement officers face stringent regulatory hurdles, intermediate shortages, and geopolitical supply volatility. Gentolex resolves these bottlenecks through backwards-integrated key starting material (KSM) synthesis, multi-site backup batch manufacturing, and strategic regional warehousing—ensuring zero supply chain disruption for commercial partners.

Custom Packaging & Bulk Logistics

To preserve chemical stability and eliminate moisture absorption, Tofacitinib Citrate API is packaged in double food/pharma-grade PE bags placed inside heat-sealed aluminum foil barrier bags, packed within heavy-duty fiber drums (5kg, 10kg, 25kg standard units). Temperature-controlled, cold-chain, and expedite customs clearance arrangements are fully supported worldwide.

World-Class Manufacturing Base & Global Hubs

Gentolex's goal is to create opportunities connecting the world with better services and guaranteed products. Up to date, Gentolex Group has been serving customers from more than 10 countries, specially, representatives are established in Mexico and South Africa.

Our main manufacturing capabilities feature an overall factory construction area of 250,000 square meters under strict international cGMP standards to offer flexible, scalable, and cost-effective solutions. We maintain state-of-the-art cleanrooms (Class 100,000 and Class 10,000), automated synthetic reactors ranging from 100L pilot scale to 5000L commercial scale, and specialized peptide synthesis facilities.

Core Turnkey Chemical & Pharmaceutical Solutions

For clients seeking comprehensive commercial partnership, our core competencies include:

• Peptide APIs & Custom Peptides: Solid-phase peptide synthesis (SPPS) and liquid-phase synthesis for therapeutic and research grade peptides.
• FDF License Out: Finished Dosage Form licensing, technical transfer packages, and bioequivalence (BE) study support.
• Technical Support & Consultation: Analytical method validation (AMV), process optimization, and regulatory audit readiness.
• Product Line & Lab Setup: Customized laboratory architecture design, analytical instrument sourcing, and cGMP compliance setup.
• Sourcing & Supply Chain Solutions: End-to-end customized procurement services leveraging our comprehensive international supply network.