Deferasirox

BluepillExpress is a globally recognized third-party pharmaceutical manufacturer committed to delivering high-quality active pharmaceutical ingredients (APIs) and finished formulations to markets worldwide. With our expertise in custom pharmaceutical production and contract manufacturing, we provide end-to-end solutions tailored to the specific needs of our clients. One of our core offerings includes the manufacturing of Deferasirox, an essential iron-chelating agent used in the management of chronic iron overload.

This comprehensive document outlines our capabilities in Deferasirox manufacturing, including formulation details, regulatory compliance, quality assurance practices, packaging options, and export potential.

Product Overview: Deferasirox

Generic Name: Deferasirox
Therapeutic Class: Iron Chelator
Dosage Forms Available: Tablets, Dispersible Tablets (DT)
Strengths Available: 125 mg, 250 mg, 500 mg
Indications:

• Chronic iron overload due to blood transfusions in patients with beta-thalassemia major and other chronic anemias
• Iron overload in non-transfusion-dependent thalassemia (NTDT) syndromes

Deferasirox is an oral iron chelator that selectively binds to excess iron in the bloodstream and facilitates its excretion, mainly via the feces. It helps to prevent complications associated with iron overload, including liver damage, cardiac toxicity, and endocrine dysfunction.

BluepillExpress Capabilities in Deferasirox Manufacturing

1. State-of-the-Art Infrastructure

BluepillExpress operates WHO-GMP and ISO-certified manufacturing facilities equipped with high-capacity machinery for the production of solid oral dosage forms. Our infrastructure is tailored to handle high-potency APIs such as Deferasirox, ensuring containment and operator safety.

Key features include:

• Dedicated HVAC-controlled cleanrooms
• Separate lines for hormone-free and high-potency products
• Automated granulation, compression, coating, and blister/strip packing lines
• Controlled environment for moisture-sensitive formulations
• In-house R&D and analytical laboratories for rapid development and validation

2. Customizable Formulations

Our third-party manufacturing services allow clients to choose from a range of Deferasirox formulations to suit market needs:

• Conventional Tablets – Film-coated tablets for ease of swallowing and improved stability
• Dispersible Tablets – Designed for pediatric and geriatric patients with swallowing difficulties
• Taste-masked Granules (customizable) – Available for pediatric applications
• Fixed Dose Combinations (on request) – Subject to feasibility studies and market requirements

Each formulation undergoes rigorous stability testing and bioequivalence studies, if required.

Manufacturing Process

Our manufacturing of Deferasirox adheres to strict standard operating procedures (SOPs) developed in accordance with international regulatory guidelines.

Key Steps Include:

• API and excipient sourcing from approved GMP-certified vendors
• Wet granulation or direct compression (depending on formulation)
• Tablet compression and coating in high-speed rotary machines
• In-process quality checks at each critical control point
• Packaging under controlled humidity to maintain drug integrity

All processes are validated to ensure batch-to-batch consistency, optimal bioavailability, and safety.

Quality Control and Assurance

BluepillExpress maintains a robust Quality Management System (QMS) to ensure compliance with global regulatory standards. Our quality assurance begins from raw material sourcing and continues through manufacturing, packaging, storage, and dispatch.

Quality Control Includes:

• Raw material and API identity/purity verification
• Microbiological and heavy metal testing
• Dissolution, disintegration, and uniformity testing
• Particle size analysis and polymorphic form characterization
• Analytical method validation for each batch

Each Deferasirox batch is subjected to comprehensive testing per pharmacopeial standards (USP/BP/EP) before being released for sale.

Regulatory Compliance

BluepillExpress follows stringent global regulations and complies with regional requirements to facilitate international marketing authorization and licensing.

Our certifications include:

• WHO-GMP
• ISO 9001:2015
• FSSAI
• Halal
• HACCP
• EU-GMP (collaborative sites, as applicable)
• USFDA (in-progress partnerships)

We assist our clients with dossier preparation, DMF submissions, stability data, and bioequivalence studies for regulatory approvals in semi-regulated and regulated markets.

Packaging & Labeling Options

Deferasirox, being a moisture-sensitive drug, demands high-barrier packaging. BluepillExpress provides a variety of secure and customizable packaging solutions:

Primary Packaging Options:

• Alu-Alu blister packs
• PVC/PVDC blister packs
• HDPE bottles with desiccants
• Individual sachet pouches for dispersible formats

Secondary Packaging:

• Printed monocartons
• Tamper-proof outer cartons with shrink-wrapping
• Multilingual labeling as per client’s regional requirements

Our in-house packaging design team supports clients in creating brand-specific packaging with a professional finish, aligned with global regulatory norms.

Private Label & Contract Manufacturing Benefits

BluepillExpress provides Deferasirox manufacturing services under both private-label and contract manufacturing models. Our business solutions are flexible, scalable, and fully confidential.

Advantages include:

• End-to-end project management from formulation to dispatch
• Complete regulatory and documentation support
• MOQ flexibility for new entrants and start-ups
• Short turnaround time and fast production cycles
• Assistance with brand name registration and packaging approvals

Clients can choose to provide their own brand and design, or leverage BluepillExpress’s in-house creative services to build their pharmaceutical identity from scratch.

Export & Global Distribution

BluepillExpress proudly exports pharmaceutical products to over 40 countries across Asia, Africa, the Middle East, CIS nations, and Latin America. We offer Deferasirox for export under various registration formats including CTD/eCTD dossiers, CoPP, and FSCs.

Export Documentation Support Includes:

• Certificate of Pharmaceutical Product (CoPP)
• Certificate of Analysis (CoA)
• Certificate of Origin (CoO)
• Stability data (zone-wise)
• GMP compliance documents
• MSDS and Technical Data Sheets

We manage shipping and logistics through validated freight partners and provide full support for cold chain and temperature-controlled transport where required.

Research and Development Support

Our R&D department plays a vital role in the development of cost-effective and high-bioavailability formulations of Deferasirox. From pre-formulation trials to analytical method development, we provide technical assistance to meet the evolving demands of international markets.

Current areas of development include:

• Taste-masked dispersible tablets for pediatric patients
• Modified-release formulations for extended chelation therapy
• Drug-device combinations for improved administration

We also provide technology transfer services and collaborative product development to scale innovations to full commercial production.

Why Choose BluepillExpress for Deferasirox Manufacturing?

Proven Track Record

Decades of experience in contract pharmaceutical manufacturing across various therapeutic segments.

Regulatory Expertise

Support for country-specific documentation and dossier development for regulated and semi-regulated markets.

Cost Efficiency

Economical pricing models without compromising on quality or compliance.

Timely Delivery

Efficient supply chain and production management to ensure timely delivery of Deferasirox batches worldwide.

Transparent Communication

Dedicated project managers for real-time updates and seamless coordination.

Therapeutic Applications of Deferasirox

Deferasirox plays a vital role in the treatment of:

• Beta-Thalassemia Major – To manage chronic transfusion-related iron overload
• Myelodysplastic Syndromes (MDS) – Particularly in adult patients undergoing long-term transfusions
• Sickle Cell Disease – Used to manage elevated iron levels from repeated transfusions
• Other Chronic Anemias – Where regular blood transfusion leads to iron accumulation
• Non-Transfusion Dependent Thalassemia (NTDT) – Where ineffective erythropoiesis causes iron loading without transfusion

With increasing awareness and diagnosis of such conditions globally, the demand for effective oral chelators like Deferasirox continues to rise—making it a strategic product for pharmaceutical marketing and distribution.

Partner with BluepillExpress

BluepillExpress invites pharmaceutical companies, healthcare distributors, marketing firms, and government tenders to collaborate with us for the third-party manufacturing of Deferasirox. Whether you aim to build your own brand or expand into emerging therapeutic markets, we are your reliable partner for superior quality, compliance, and affordability.