Azathioprine

BluepillExpress, a globally recognized third-party pharmaceutical manufacturer and exporter, offers comprehensive manufacturing solutions for Azathioprine, a crucial immunosuppressive agent used in the management of autoimmune diseases and post-transplant therapy. Known for adhering to international regulatory guidelines and maintaining the highest standards of quality, BluepillExpress enables pharmaceutical brands, hospitals, and distributors to deliver reliable Azathioprine formulations to markets worldwide.

Our third-party manufacturing services cater to companies seeking strategic outsourcing solutions that include cost-efficiency, scalable production, timely delivery, and GMP-certified manufacturing practices.

About Azathioprine

Azathioprine is a purine analog immunosuppressive drug used primarily in the treatment of autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease (Crohn’s disease and ulcerative colitis), and in preventing organ transplant rejection. It is commonly available in oral tablet form and sometimes as an injectable formulation.

Pharmacology and Mechanism of Action

Azathioprine is a prodrug that converts into 6-mercaptopurine in the body. It inhibits purine synthesis, thereby suppressing the proliferation of T and B lymphocytes, which are essential components of the immune response. By modulating the immune system, Azathioprine plays a critical role in reducing inflammation and preventing graft-versus-host reactions.

BluepillExpress Manufacturing Capabilities for Azathioprine

BluepillExpress brings advanced pharmaceutical technology and regulatory compliance together to deliver world-class third-party manufacturing services for Azathioprine.

1. Formulations Offered

We offer third-party manufacturing of Azathioprine in various dosage strengths and formats, including:

• Azathioprine 25 mg Tablets
• Azathioprine 50 mg Tablets
• Customized strength tablets upon client request
• Injectable solutions (on demand)

All formulations are developed to meet stringent pharmacopoeial specifications including USP, BP, and IP standards.

2. Manufacturing Facility Highlights

Our manufacturing units are:

• WHO-GMP certified
• ISO 9001:2015 compliant
• Equipped with automated, sterile, and climate-controlled environments
• Supported by in-house R&D and quality control laboratories
• Certified for exports to regulated and semi-regulated markets including the Middle East, Africa, Asia-Pacific, Latin America, and CIS countries

3. Packaging Options

We offer customized, tamper-proof packaging options to preserve product integrity and enhance brand visibility:

• Blister packs (Alu-Alu and PVC)
• HDPE bottles
• Bulk packing for institutional supplies
• Patient-ready cartons with multilingual labeling

Regulatory and Quality Assurance Standards

BluepillExpress strictly complies with international regulatory norms for the manufacturing of Azathioprine. Our quality assurance protocols are designed to meet the following guidelines:

• Good Manufacturing Practices (GMP)
• ICH Q7 and Q10 guidelines
• Pharmacopoeial standards (USP/BP/IP/EP)
• Stringent quality control procedures at every stage of production

Each batch undergoes:

• Assay and content uniformity tests
• Dissolution profile analysis
• Stability testing under ICH-recommended conditions
• Microbial limit testing
• Heavy metal and residual solvent analysis

Documentation provided with shipments includes:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Method of Analysis (MoA)
• Material Safety Data Sheets (MSDS)
• Stability data (as required)

Contract Manufacturing Process at BluepillExpress

Step-by-Step Process:

1. Client Consultation
   • Understanding client requirements
   • Determining product specifications, batch sizes, and registration needs
2. Product Development
   • Formulation customization
   • Stability trials and pilot batch production
3. Documentation and Compliance
   • Preparation of technical dossiers (CTD format if required)
   • Compliance with country-specific regulatory requirements
4. Production Planning
   • Allocation of production slots
   • Procurement of high-purity APIs and excipients
5. Manufacturing and Quality Control
   • GMP-compliant manufacturing
   • In-process quality checks
6. Packaging and Labeling
   • Branding and design support
   • Multilingual labels and patient leaflets
7. Shipping and Logistics
   • Global shipping support with cold chain logistics (if required)
   • Export documentation and customs clearance support

Advantages of Partnering with BluepillExpress

1. End-to-End Support

We assist clients from formulation development to regulatory submission and logistics, offering a full-service manufacturing experience.

2. Global Market Reach

Our export-ready solutions meet registration requirements across a wide range of countries, allowing our clients to enter new markets with confidence.

3. R&D and Customization

Our in-house R&D team helps develop customized strengths, combinations, and novel delivery systems tailored to specific market needs.

4. Regulatory Documentation Expertise

We support clients with:

• Dossiers in CTD format
• Registration support in target markets
• Assistance with bioequivalence studies (if required)

5. Scalability and Fast Turnaround

With a robust supply chain and agile production planning, we accommodate both small and large batch production with industry-leading turnaround times.

Applications of Azathioprine

Azathioprine is prescribed across several medical specialties due to its broad immunosuppressive activity.

1. Autoimmune Disorders

• Rheumatoid Arthritis
• Systemic Lupus Erythematosus (SLE)
• Vasculitis syndromes

2. Inflammatory Bowel Disease

• Crohn’s Disease
• Ulcerative Colitis

Azathioprine helps maintain remission and reduce dependence on corticosteroids.

3. Organ Transplantation

Used in conjunction with other immunosuppressants (e.g., corticosteroids or cyclosporine) to prevent rejection in:

• Renal transplants
• Liver transplants
• Cardiac transplants

Why Azathioprine Manufacturing Matters

Azathioprine remains a key immunosuppressive drug with widespread application. Despite the development of newer biologics, Azathioprine remains a preferred choice due to:

• Proven clinical efficacy
• Oral bioavailability
• Cost-effectiveness
• Inclusion in essential drug lists across many countries

By offering reliable third-party manufacturing of Azathioprine, BluepillExpress contributes to global healthcare by ensuring patients have access to affordable and effective treatment options.

Client Profile – Who Can Partner with Us?

BluepillExpress serves a diverse range of clients looking for Azathioprine third-party manufacturing, including:

• Generic drug companies
• International pharmaceutical distributors
• Hospital procurement bodies
• NGOs and public health programs
• E-commerce pharmacy platforms
• Government tenders and institutional buyers

Certifications and Accreditations

Our facilities and systems are compliant with:

• WHO-GMP
• ISO 9001:2015
• FSSAI (for nutraceutical formats if required)
• Drug Controller General of India (DCGI)
• NDA, FDA (for registration support, country-specific)

These certifications ensure that our clients receive products manufactured under the highest standards of safety, efficacy, and quality.

Conclusion

BluepillExpress is proud to offer reliable and high-quality third-party manufacturing services for Azathioprine, enabling pharmaceutical brands and healthcare providers to meet growing global demands. From formulation development to global logistics, we provide comprehensive solutions under one roof, backed by regulatory expertise, world-class infrastructure, and customer-focused flexibility.

Whether you’re looking to expand your product portfolio, launch in a new region, or streamline your supply chain with a trusted manufacturing partner, BluepillExpress is the name you can count on.