Everolimus

Everolimus is a widely used pharmaceutical compound belonging to the mTOR inhibitor class. It plays a pivotal role in oncology, transplant medicine, and the treatment of rare tumors. As a derivative of sirolimus, Everolimus is integral to several therapeutic protocols, offering immunosuppressive and antiproliferative properties. At BluepillExpress, we specialize in the third-party manufacturing of high-quality Everolimus formulations, adhering to global quality benchmarks and regulatory requirements.

We provide seamless contract manufacturing services for pharmaceutical businesses, healthcare brands, and global distributors looking for a reliable partner in the production of Everolimus tablets in multiple dosage strengths. Our end-to-end services cover formulation development, manufacturing, quality control, packaging, and global export support.

About Everolimus

• Generic Name: Everolimus
• Therapeutic Class: mTOR (mammalian target of rapamycin) inhibitor
• Pharmacological Action: Immunosuppressant and anti-cancer agent
• Common Dosage Forms: Tablets (e.g., 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, 2.5 mg, 5 mg, 7.5 mg, 10 mg)
• Brand Equivalents: Afinitor, Zortress, Certican, etc.

Everolimus is primarily used in the treatment of hormone receptor-positive, HER2-negative breast cancer, renal cell carcinoma, pancreatic neuroendocrine tumors, and subependymal giant cell astrocytoma. It is also used for the prophylaxis of organ rejection in kidney and liver transplant patients.

BluepillExpress: Your Strategic Partner in Everolimus Manufacturing

At BluepillExpress, we leverage our pharmaceutical expertise and advanced infrastructure to deliver Everolimus formulations that meet the highest global quality and safety standards. Our production facilities are WHO-GMP certified, ISO-compliant, and designed to support international pharmaceutical partners through scalable and efficient manufacturing solutions.

Key Services Offered:

• Customizable dosage strengths and packaging options
• Regulatory document support (Dossiers, CoAs, MoA, Stability Data, etc.)
• Complete IP protection and confidentiality assurance
• Dedicated quality assurance and regulatory compliance teams
• Global supply chain and logistics coordination

Manufacturing Capabilities

Our manufacturing facilities are equipped to produce Everolimus in various oral solid dosage forms with precision and consistency. The entire production process is compliant with Good Manufacturing Practices (GMP) and ICH guidelines, ensuring batch-to-batch uniformity and safety.

Formulation Types:

• Conventional Tablets
• Film-coated Tablets
• Modified-release Tablets
• Blister or bottle packaging options available

Dosage Strengths Available:

• 0.25 mg
• 0.5 mg
• 0.75 mg
• 1 mg
• 2.5 mg
• 5 mg
• 7.5 mg
• 10 mg

We also offer formulation flexibility based on your market-specific requirements, therapeutic needs, and branding preferences.

Quality Assurance and Regulatory Compliance

At BluepillExpress, our commitment to quality begins from the procurement of raw materials and continues through every stage of production, packaging, and delivery. Our QA/QC team implements rigorous quality checks, including:

• Raw Material Testing
• In-Process Quality Control
• Finished Product Analysis
• Stability Testing
• Microbial and Contamination Testing
• Dissolution & Disintegration Profiling
• HPLC and FTIR for assay and impurity profiling

We provide full regulatory support including:

• Certificate of Analysis (CoA)
• Certificate of Pharmaceutical Product (COPP)
• Stability Data
• Master Formula Record (MFR)
• Batch Manufacturing Record (BMR)
• Technical Data Sheet
• Material Safety Data Sheet (MSDS)
• Method of Analysis (MoA)

Why Choose BluepillExpress for Everolimus Third-Party Manufacturing?

1. High-Precision Manufacturing

We employ advanced granulation and compression technologies that ensure precise dosage uniformity in each Everolimus tablet. Our specialized equipment is calibrated to handle cytotoxic and high-potency APIs like Everolimus with the utmost care.

2. Global Standards & Certifications

Our units are WHO-GMP compliant and ISO 9001:2015 certified. We also meet the stringent requirements of international markets such as the EU, Africa, Southeast Asia, CIS, LATAM, and the Middle East.

3. Custom Branding Solutions

Whether you need white labeling, private labeling, or branding support, BluepillExpress ensures that your Everolimus products are tailored to meet your market image and positioning strategies.

4. Regulatory Dossier Support

We help you penetrate regulated and semi-regulated markets by offering complete regulatory dossier preparation services (in CTD/eCTD formats) and technical documentation, aiding faster product registration.

5. Confidentiality and IP Protection

Your formulations and proprietary information are secure with us. We offer robust non-disclosure agreements (NDAs) to protect your business interests throughout the manufacturing partnership.

Therapeutic Applications of Everolimus

Everolimus has multiple therapeutic applications, making it a valuable product line for pharmaceutical companies. Here are the primary indications for which Everolimus is prescribed:

• Oncology
  • Advanced hormone receptor-positive breast cancer
  • Advanced renal cell carcinoma (RCC)
  • Pancreatic neuroendocrine tumors (pNET)
  • Gastrointestinal and lung neuroendocrine tumors
• Transplant Medicine
  • Prophylaxis of organ rejection in kidney and liver transplantation
• Rare Disease Treatment
  • Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC)

Packaging & Labeling Solutions

We provide Everolimus packaging solutions that align with global regulatory mandates and client branding requirements.

Options Include:

• Blister packs (Alu-Alu / PVC)
• HDPE bottles with child-resistant caps
• Secondary cartons with tamper-evident seals
• Multilingual label printing
• Serialization & barcoding for track-and-trace systems

We ensure all packages are designed for patient safety and shelf stability, with long-term protection from moisture and light.

Research and Development (R&D) Support

Our in-house R&D department constantly explores new delivery forms, bioequivalence optimization, and cost-effective formulations of Everolimus. Clients can benefit from our innovation in:

• Enhancing bioavailability
• Developing alternative release profiles
• Improving patient compliance through taste masking or size reduction

Our R&D services are available for partners looking to introduce differentiated Everolimus formulations in their markets.

Supply Chain & Export Logistics

BluepillExpress manages an efficient and reliable global supply chain. From raw material sourcing to final shipment, we ensure end-to-end traceability, proper documentation, and timely delivery.

Our export services cover:

• Freight Forwarding & Customs Clearance
• Air & Sea Logistics Coordination
• Cold Chain Packaging (if required)
• Market-Specific Regulatory Compliance
• Export Documentation (Invoice, Packing List, COO, Free Sale Certificate, etc.)

We have the experience and infrastructure to supply Everolimus to both regulated and semi-regulated international markets.

Partner with BluepillExpress

If you are a pharmaceutical distributor, brand owner, or healthcare institution looking for a trusted third-party manufacturing partner for Everolimus, BluepillExpress is your ideal solution. Our scientific expertise, global compliance readiness, and manufacturing flexibility make us a reliable choice in the oncology and immunosuppressant segment.

Whether you’re planning to launch a new brand or expand your oncology portfolio, BluepillExpress provides the tools, technology, and trust you need for a successful partnership.