Tacrolimus

At BluepillExpress, we take immense pride in offering world-class third-party manufacturing services for Tacrolimus, a critical immunosuppressive medication widely used to prevent organ rejection in transplant patients. Our commitment to delivering excellence in pharmaceutical manufacturing ensures that every product meets international standards of quality, safety, and efficacy. With a robust infrastructure, skilled team, and global compliance certifications, BluepillExpress is a leading force in contract manufacturing for pharmaceutical partners worldwide.

Overview of Tacrolimus

Tacrolimus is a macrolide lactone with potent immunosuppressive properties. It works primarily by inhibiting T-lymphocyte activation and is essential in preventing rejection following organ transplantation, particularly in liver, kidney, and heart transplants. Additionally, Tacrolimus has clinical applications in treating certain dermatological and autoimmune disorders when used topically or systemically.

• Generic Name: Tacrolimus
• Therapeutic Class: Immunosuppressant
• Pharmacological Action: Calcineurin Inhibitor
• Formulations: Capsules, Tablets, Ointments, and Injections
• Dosage Strengths: Commonly available in 0.5 mg, 1 mg, 5 mg capsules; ointment in 0.03% and 0.1% concentrations

Why Choose BluepillExpress for Tacrolimus Manufacturing?

BluepillExpress is known for offering unmatched expertise in third-party pharmaceutical manufacturing. We ensure seamless contract manufacturing solutions tailored to meet client specifications and regulatory obligations.

1. GMP-WHO Certified Facilities

Our manufacturing units are GMP-WHO certified, ensuring that all Tacrolimus products are manufactured under stringent quality control and hygienic conditions. Every batch undergoes rigorous quality assurance procedures from raw material sourcing to finished product packaging.

2. Dedicated R&D Support

Tacrolimus requires meticulous formulation development due to its narrow therapeutic index and sensitivity to degradation. Our dedicated research and development team specializes in:

• Enhancing bioavailability
• Stability optimization
• Controlled-release formulations
• Innovation in topical delivery systems

3. Regulatory Compliance

BluepillExpress is fully compliant with national and international regulatory guidelines including:

• USFDA (for export purposes)
• EUGMP
• TGA
• MHRA
• CDSCO India

This makes our Tacrolimus formulations suitable for both domestic and global markets.

4. Flexible Batch Sizes & Customization

Whether you’re a startup, growing pharmaceutical company, or an established international brand, BluepillExpress offers flexible batch sizes and private labeling options for Tacrolimus. We cater to both bulk supply and small-scale orders, ensuring timely delivery and cost-effective production.

Tacrolimus Dosage Forms Offered at BluepillExpress

We specialize in multiple delivery formats of Tacrolimus to suit diverse clinical needs and market demands:

A. Tacrolimus Capsules

• Dosages: 0.5 mg, 1 mg, 5 mg
• Packaging: Alu-Alu and Blister Packs
• Features:
  • High purity API
  • Sustained-release options
  • Tamper-evident packaging
  • Custom branding available

B. Tacrolimus Ointment

• Concentrations: 0.03%, 0.1%
• Base: Non-comedogenic, fragrance-free ointment base
• Packaging: Tubes (5g, 10g, 30g) with laminated or aluminum collapsible options
• Indications: Atopic dermatitis, psoriasis, eczema

C. Tacrolimus Tablets (Upon Request)

• Form: Modified-release or immediate-release
• Features: Suitable for controlled pharmacokinetics

D. Tacrolimus Injection (Lyophilized or Solution)

• Strength: Available on custom formulation
• Packaging: Vials with sterile sealing under aseptic conditions
• Usage: For acute rejection episodes in transplant units

Manufacturing Process Overview

At BluepillExpress, the manufacturing process for Tacrolimus involves high precision and sterility:

1. API Procurement & Testing

We source the Active Pharmaceutical Ingredient (API) from certified vendors with COA and DMF support. Every batch undergoes comprehensive lab analysis for purity, potency, and contaminants.

2. Formulation Development

Our pharmaceutical scientists develop Tacrolimus formulations focusing on:

• Solubility enhancement
• pH compatibility
• Stability under various climatic zones (ICH conditions)
• Reduced irritation for topical forms

3. Production

Our automated production lines ensure:

• Accurate dosing
• Minimal human intervention
• ISO Class 8 (or better) cleanroom environment
• Adherence to validated SOPs

4. Quality Control & Assurance

Each Tacrolimus product batch is tested for:

• Content uniformity
• Dissolution profile
• Microbial contamination
• Packaging integrity
  All reports are compiled into a Certificate of Analysis (CoA) for client delivery.

5. Packaging & Labeling

We offer custom branding, multilingual labeling, and export-compliant packaging for global partners. Options include tamper-proof, child-resistant, and eco-friendly materials.

Documentation and Support

BluepillExpress provides full regulatory and technical documentation for smooth registration in your target market:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Stability Data
• Method of Analysis (MoA)
• Product Dossier (CTD format if required)
• GMP Certificate
• Free Sale Certificate (if needed)

We also support filing assistance for semi-regulated and regulated markets.

Contractual Flexibility

We accommodate various business models including:

• Private Label Manufacturing
• Loan License Manufacturing
• Bulk Supply with Client Branding
• End-to-End Product Lifecycle Support

Whether you seek a ready-to-market product or want to create a custom Tacrolimus formulation, we provide the infrastructure and expertise to bring your product to market efficiently.

International Reach and Export Support

BluepillExpress is a trusted pharmaceutical export partner in 30+ countries across:

• Southeast Asia
• Africa
• South America
• Middle East
• CIS and Eastern Europe

Our Tacrolimus products are export-ready, and we handle all regulatory and logistics support including:

• Global shipping
• Cold chain logistics (if required)
• Documentation for customs clearance
• Country-specific artwork and labeling

Client-Centric Approach

Every client is assigned a dedicated project coordinator to oversee the lifecycle of Tacrolimus product development — from order placement to delivery. Our support team ensures:

• Regular updates on batch progress
• Rapid response to technical queries
• Transparency in cost and delivery timelines
• Strict adherence to confidentiality and IP protection

Sustainability & Compliance

At BluepillExpress, we’re committed to sustainable and ethical manufacturing. Our facilities adopt:

• Energy-efficient processes
• Minimal waste generation techniques
• Eco-conscious packaging solutions
• Ethical sourcing and fair labor practices

We also comply with:

• ISO 9001:2015 Quality Management
• ISO 14001:2015 Environmental Management
• ISO 45001:2018 Occupational Health & Safety

Partner With BluepillExpress Today

Tacrolimus is a high-value product that demands precision manufacturing and unwavering quality control. At BluepillExpress, we offer everything you need to launch or scale your Tacrolimus brand — from technical support and formulation development to regulatory documentation and global delivery.

Our proven track record in third-party pharmaceutical manufacturing and dedication to compliance, confidentiality, and customization makes us the partner of choice for global pharmaceutical companies.