IndiaMart
FIEO
BluepillExpress is a globally recognized pharmaceutical third-party manufacturing and merchant export company, specializing in the production of high-quality drug formulations that comply with international standards. Among our diverse and expanding product portfolio, we offer comprehensive third-party manufacturing services for Tamsulosin Hydrochloride (Modified Release) & Dutasteride, a widely prescribed combination therapy used in the treatment of Benign Prostatic Hyperplasia (BPH).
With a commitment to precision, quality, and timely delivery, BluepillExpress has emerged as a trusted name in the pharmaceutical industry, especially for clients seeking customized formulations, international quality compliance, and scalable production solutions.
Product Overview
Tamsulosin Hydrochloride (Modified Release) and Dutasteride is a fixed-dose combination drug used primarily to treat symptoms of enlarged prostate in adult men. Tamsulosin is an alpha-1 adrenergic receptor antagonist, while Dutasteride is a 5-alpha-reductase inhibitor. Together, they provide synergistic relief from urinary symptoms by improving urine flow and reducing prostate size over time.
This medication is typically formulated in modified-release capsules or tablets to ensure controlled and sustained release of Tamsulosin, enhancing patient compliance and therapeutic efficacy.
Therapeutic Uses
The combination of Tamsulosin Hydrochloride (MR) and Dutasteride is widely used in the treatment of:
- Benign Prostatic Hyperplasia (BPH)
- Lower urinary tract symptoms (LUTS) associated with BPH
- Urinary retention
- Frequent or difficult urination due to prostate enlargement
This dual therapy addresses both dynamic and static components of BPH, offering effective long-term symptom management.
Dosage Form and Strengths
At BluepillExpress, we offer flexibility in the development and manufacturing of various dosage forms and strengths based on client specifications and market requirements. Common strengths include:
- Tamsulosin Hydrochloride (MR) 0.4 mg + Dutasteride 0.5 mg capsules
- Customized strengths and formulations upon request
Our research and development team can assist in creating tailored formulations to meet regional regulatory requirements and customer preferences.
Manufacturing Capabilities
BluepillExpress operates state-of-the-art manufacturing facilities equipped with the latest technologies to ensure high-quality production of modified-release combination drugs. Our capabilities include:
- Modified Release Technology
- Expertise in sustained and controlled-release formulation
- Optimized drug release profiles to enhance bioavailability
- Specialized coating and encapsulation equipment
- Encapsulation & Tableting
- Advanced high-speed capsule filling machines
- Consistent dosage uniformity
- Multi-stage quality assurance protocols
- Stability and Shelf-Life Enhancement
- Use of desiccants, protective packaging, and anti-oxidative materials
- Comprehensive stability testing as per ICH guidelines
- Batch Size Flexibility
- Pilot-scale batches for market testing
- Commercial-scale production for global distribution
Quality Assurance and Regulatory Compliance
BluepillExpress upholds stringent quality assurance practices at every step of the manufacturing process. Our facilities are certified and compliant with:
- WHO-GMP (World Health Organization – Good Manufacturing Practice)
- ISO 9001:2015 Quality Management Standards
- FSSAI Compliance (for applicable categories)
- US FDA and EU GMP Guidance (for selected facilities)
- Schedule M compliance under Indian Drugs & Cosmetics Act
Quality control laboratories at BluepillExpress are equipped with HPLC, GC, UV Spectrophotometers, Dissolution Testers, and other analytical instruments to ensure every batch meets pharmacopoeial standards (IP, BP, USP, Ph. Eur).
Packaging and Labeling
We understand that packaging is critical not only for product stability but also for brand visibility and regulatory approval. At BluepillExpress, we provide comprehensive packaging solutions:
- Blister packs (Alu-Alu / Alu-PVC)
- HDPE bottles with child-resistant caps
- Custom-designed outer cartons
- Regulatory compliant labeling (as per FDA, EMA, or local authorities)
Our in-house design and printing team supports customized branding for clients, making the product market-ready with attractive and informative packaging.
Private Labeling and Branding
As part of our third-party manufacturing services, BluepillExpress offers private labeling for pharmaceutical companies looking to market under their own brand name. We provide:
- Product development under your brand
- Regulatory document support (COAs, COPPs, MSDS, etc.)
- Tailored marketing materials (inserts, visual aids)
- Packaging design services
This turnkey model enables you to launch or expand your brand without investing in manufacturing infrastructure.
Research & Development
Our R&D division is continuously working to improve the efficacy, bioavailability, and patient compliance of fixed-dose combinations like Tamsulosin Hydrochloride (MR) & Dutasteride. Innovations include:
- Enhanced stability profiles
- Alternate release profiles (once-daily dosing)
- Compatibility with other APIs for multi-action therapy
- Bioequivalence studies to match branded innovator products
This allows our partners to stay ahead of market trends and provide superior therapeutic options to their customers.
Documentation and Support
We provide complete regulatory and technical documentation required for product registration and export:
- Product dossiers in CTD format
- Certificate of Analysis (CoA)
- Certificate of Pharmaceutical Product (CoPP)
- MSDS (Material Safety Data Sheet)
- Manufacturing License & GMP certificates
- Batch Manufacturing Records (BMRs)
Our dedicated documentation team ensures timely and accurate submissions to support regulatory filings across different geographies.
Global Export and Distribution Network
BluepillExpress serves clients in over 40+ countries including the Middle East, Africa, South East Asia, CIS countries, Latin America, and parts of Europe. We offer export-ready batches with global regulatory compliance, ensuring seamless customs clearance and on-time delivery.
Our logistics and export team handles:
- Documentation for international shipping
- Cold chain logistics (if required)
- Packaging suitable for long-distance transport
- Port-specific labeling and barcoding
Why Choose BluepillExpress?
Partnering with BluepillExpress for the third-party manufacturing of Tamsulosin Hydrochloride (Modified Release) & Dutasteride brings multiple advantages:
- Customized Formulations: Tailored to meet specific therapeutic and market needs
- International Quality Standards: WHO-GMP and ISO-certified manufacturing
- Scalability: From pilot batches to commercial-scale production
- Regulatory Expertise: Complete support with filings and documentation
- Timely Delivery: Strict adherence to production timelines
- Competitive Pricing: Cost-effective solutions without compromising on quality
Client Onboarding Process
The third-party manufacturing process at BluepillExpress is streamlined and client-centric:
- Requirement Discussion
- Product specifications
- Packaging and branding preferences
- Target market and regulatory framework
- Quotation and Proposal
- Commercial offer based on volume, formulation, and packaging
- Agreement and Documentation
- Signing of third-party manufacturing agreement
- Provision of required licenses and certificates
- Production and Quality Testing
- Pilot batch manufacturing (if required)
- Full-scale production after approvals
- Packaging and Dispatch
- Final QA checks, labeling, and shipment as per client location
- Post-Dispatch Support
- Assistance with import clearances, marketing materials, and re-orders
Conclusion
At BluepillExpress, we combine pharmaceutical expertise with a global outlook to deliver high-quality, customized third-party manufacturing services for Tamsulosin Hydrochloride (Modified Release) & Dutasteride. Whether you are a startup brand looking to enter the market or an established company seeking reliable production partners, we provide the tools and technology to scale your business.
We invite you to collaborate with us and experience the BluepillExpress standard of excellence — where science meets trust and innovation meets quality.
