IndiaMart
FIEO
BluepillExpress is a globally recognized pharmaceutical manufacturing and exporting company based in India, offering top-tier third-party manufacturing solutions for a wide range of therapeutic categories, including bone health and osteoporosis management. One of our flagship offerings in this category is Alendronate, a bisphosphonate medication widely used for the prevention and treatment of osteoporosis and other bone-related disorders.
As a compliant, GMP-certified, and internationally accredited pharmaceutical partner, BluepillExpress is fully equipped to meet the increasing global demand for high-quality, affordable, and regulatory-compliant Alendronate formulations. Whether you are a startup brand, established pharmaceutical distributor, or a global procurement agency, our third-party manufacturing services are tailored to ensure consistency, quality, and timely delivery.
About Alendronate
Alendronate, chemically known as Alendronic Acid, is a bisphosphonate that inhibits bone resorption by osteoclasts. It is primarily indicated for:
- Treatment and prevention of osteoporosis in postmenopausal women.
- Increase of bone mass in men with osteoporosis.
- Treatment of glucocorticoid-induced osteoporosis in both genders.
- Management of Paget’s disease of bone.
Available in both oral and parenteral forms, Alendronate is commonly prescribed in once-weekly or daily dosage regimens to improve patient compliance and therapeutic outcomes. It is often available in tablet strengths such as 5 mg, 10 mg, 35 mg, 70 mg, and in combination with Vitamin D3.
BluepillExpress: Your Trusted Third-Party Manufacturing Partner for Alendronate
State-of-the-Art Manufacturing Infrastructure
At BluepillExpress, our WHO-GMP and ISO-certified manufacturing facilities are equipped with advanced machinery, automated packaging units, high-capacity granulation systems, and modern analytical laboratories. Our infrastructure is designed to support large-scale batch production of Alendronate with:
- High throughput capacity for bulk orders.
- Fully compliant HVAC and environmental monitoring systems.
- Segregated production zones for cross-contamination control.
Our facilities are strategically located to ensure seamless logistics and prompt export services to over 140 countries worldwide.
Formulation and Dosage Options
We offer comprehensive third-party manufacturing services for Alendronate in various dosage forms, which include:
- Alendronate Tablets (5 mg, 10 mg, 35 mg, 70 mg)
- Alendronate + Vitamin D3 Combination Tablets
- Effervescent Tablets (custom formulations available)
- Alendronate Oral Solutions (on custom request)
Each formulation is manufactured in accordance with pharmacopeial standards (USP, BP, IP, or as per client-specific monographs) and packaged to suit global market preferences.
Regulatory Compliance and Global Standards
Our commitment to regulatory excellence ensures that every batch of Alendronate complies with:
- GMP, WHO-GMP, and ISO 9001:2015 certifications.
- Adherence to ICH Q7, Q8, Q9, and Q10 guidelines for pharmaceutical quality systems.
- Pharmacopoeial conformity with USP/BP/EP/IP specifications.
- Full support with DMF, COPP, MSDS, and COA documentation.
- Compliance with MHRA (UK), TGA (Australia), PIC/S, and ANVISA (Brazil) where applicable.
This ensures smooth product registration and regulatory approval across diverse international markets.
Customization and Branding Support
BluepillExpress offers private labeling and custom packaging solutions to help you establish your brand identity effectively. Our third-party manufacturing services allow clients to:
- Choose custom tablet colors, coatings, shapes, and embossing.
- Select primary and secondary packaging options (Alu-Alu, Blister, Bottle).
- Design and print custom leaflets, cartons, and labels with your brand name and marketing artwork.
- Comply with local labeling regulations (e.g., FDA, EMA, CDSCO, etc.)
We also assist in product dossier preparation, brand registration, and provide marketing collaterals on request.
Quality Assurance and Testing
Every batch of Alendronate produced at BluepillExpress undergoes strict quality control at various stages, including:
- Raw material and excipient testing.
- In-process checks for blend uniformity, tablet weight, hardness, and disintegration time.
- Final product testing for assay, dissolution, microbial load, and stability.
- Comprehensive stability studies under ICH guidelines (Zone II and IVb).
All analytical data is recorded, validated, and documented in accordance with cGMP standards to ensure complete traceability and accountability.
Supply Chain Efficiency and Logistics Support
We understand the importance of timely delivery in the global pharmaceutical market. With our dedicated supply chain division, we ensure:
- On-time manufacturing and dispatch schedules.
- Partnerships with certified freight forwarders and courier services.
- Cold chain and ambient shipping options based on product requirements.
- Seamless customs clearance assistance and export documentation support.
Whether you require shipping by air, sea, or land, we manage your orders end-to-end to ensure hassle-free delivery.
Dedicated Client Services
BluepillExpress prides itself on offering dedicated account management and full-service client support. As part of our third-party manufacturing partnership, you receive:
- A single point of contact for your account.
- Daily production updates and real-time status reporting.
- Technical support for formulation, analytical queries, and regulatory submissions.
- Flexible MOQ (Minimum Order Quantity) models to support startups and growing enterprises.
We strive to build long-term relationships based on transparency, consistency, and mutual growth.
Why Choose BluepillExpress for Alendronate Manufacturing?
Choosing BluepillExpress as your third-party manufacturer ensures that you benefit from:
- Global reach with clients in over 140 countries.
- End-to-end solutions, from product development to global distribution.
- Competitive pricing without compromising on quality.
- Customizable services to align with your marketing and regulatory needs.
- Full traceability and documentation, ensuring complete quality and compliance assurance.
With an in-depth understanding of global regulatory frameworks, strong production capabilities, and a customer-centric approach, BluepillExpress is your ideal partner for Alendronate third-party manufacturing.
Alendronate Manufacturing: Technical Overview
| Attribute | Details |
|---|---|
| Product Name | Alendronate |
| Therapeutic Class | Bisphosphonates – Osteoporosis Treatment |
| Available Strengths | 5 mg, 10 mg, 35 mg, 70 mg |
| Combination Option | Alendronate + Vitamin D3 |
| Formulations Offered | Tablets, Combination Tablets, Oral Solutions |
| Certifications | GMP, WHO-GMP, ISO 9001:2015, HACCP |
| Packaging Types | Alu-Alu, Blister, Bottle, Custom Options |
| MOQ (Minimum Order Quantity) | Flexible (varies based on dosage and formulation) |
| Lead Time | 30–45 days post artwork and commercial confirmation |
| Regulatory Documents | COA, COPP, FSC, MSDS, Product Dossier, Stability Data |
Conclusion
The growing burden of osteoporosis and other bone disorders globally makes Alendronate an essential component of any pharmaceutical product portfolio. At BluepillExpress, we are committed to delivering scientifically backed, regulatory-compliant, and cost-effective Alendronate formulations for clients worldwide through our comprehensive third-party manufacturing services.
If you are looking to expand your product line with a reliable and high-quality Alendronate offering, BluepillExpress is your strategic partner of choice.
