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Leniolisib phosphate bulk supplier for pharma manufacturers

Leniolisib Phosphate Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 70 mg

Reference Brands: Joenja (USA/EU)

Category: Immune Disorder

Leniolisib phosphate is available in Tablets and strengths such as 70 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Leniolisib phosphate is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Leniolisib phosphate can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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📘 Sourcing Guide

Product Description:

Leniolisib phosphate, marketed under the brand name Joenja, is a targeted kinase inhibitor used for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS). It is indicated for patients aged twelve years and older who are diagnosed with this rare primary immunodeficiency disorder. APDS is caused by mutations in the PIK3CD or PIK3R1 genes, which play a critical role in regulating the development and function of immune cells.

These genetic abnormalities lead to impaired maturation of B cells and T cells, resulting in weakened immune responses and an increased susceptibility to recurrent bacterial and viral infections. Leniolisib phosphate works by selectively inhibiting the PI3Kδ enzyme, helping to restore balance in immune signaling pathways and improve immune cell function. Unlike broad immunosuppressive therapies, this targeted approach addresses the underlying molecular mechanism of the disease.

Leniolisib phosphate is administered orally and is intended for long-term management under specialist supervision. As a precision therapy developed for a genetically defined condition, its use requires appropriate diagnostic confirmation and ongoing clinical monitoring to ensure safety and therapeutic effectiveness.

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Frequently Asked Questions

Leniolisib phosphate is used for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adult and pediatric patients aged 12 years and older.

Leniolisib phosphate is a synthetic small-molecule drug formulated as a phosphate salt, designed to selectively inhibit the PI3Kδ enzyme.

The trade name of leniolisib phosphate is Joenja.

Joenja is developed and marketed by Pharming Group N.V.

The complete generic name is leniolisib phosphate.

The approved brand name is Joenja.

Leniolisib phosphate is manufactured in GMP-approved facilities in Europe and other regulated pharmaceutical manufacturing locations, depending on the authorized supply chain.

Yes, Leniolisib phosphate is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Leniolisib phosphate is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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