IndiaMart
FIEO
At BluepillExpress, we are committed to providing high-quality, reliable, and efficient third-party manufacturing services for a wide range of pharmaceutical products, including combination therapies for urological health. One such vital combination is Tamsulosin Hydrochloride (Modified Release) & Finasteride, a clinically approved treatment primarily used in the management of benign prostatic hyperplasia (BPH). This dual-action medication offers both symptomatic relief and progression control of the enlarged prostate condition.
By choosing BluepillExpress as your third-party manufacturing partner, pharmaceutical brands and healthcare companies gain access to cutting-edge technology, global-standard manufacturing infrastructure, and regulatory-compliant production processes. We specialize in manufacturing modified-release formulations that demand precision, scientific rigor, and GMP-compliant protocols.
Product Overview: Tamsulosin Hydrochloride (MR) & Finasteride
1. Tamsulosin Hydrochloride (Modified Release)
Tamsulosin is an alpha-1 adrenergic receptor antagonist, specifically targeting the smooth muscle in the prostate and bladder neck to relax it, thereby improving urine flow and reducing BPH-related symptoms such as difficulty in urination, weak stream, and nocturia. The modified-release (MR) version ensures that the active ingredient is released gradually into the bloodstream, enhancing therapeutic efficacy and minimizing side effects.
2. Finasteride
Finasteride is a 5-alpha-reductase inhibitor that prevents the conversion of testosterone to dihydrotestosterone (DHT), a hormone responsible for prostate enlargement. By lowering DHT levels, Finasteride helps shrink the prostate over time and prevents disease progression.
3. Combination Therapy
This combination works synergistically—Tamsulosin provides rapid symptomatic relief, while Finasteride addresses the root cause of prostate growth. The fixed-dose combination is clinically proven to be more effective than monotherapy in moderate to severe BPH cases.
Dosage Form & Strengths
At BluepillExpress, we manufacture orally administered tablets or capsules of Tamsulosin Hydrochloride (Modified Release) 0.4 mg + Finasteride 5 mg. We offer flexible packaging formats such as blister packs, alu-alu strips, or HDPE bottles in accordance with client requirements and market preferences.
Therapeutic Indications
The combination of Tamsulosin MR and Finasteride is indicated for:
- Benign Prostatic Hyperplasia (BPH) – to treat and manage symptoms such as urinary hesitancy, increased frequency, incomplete bladder emptying, and weak stream.
- Reduction of the risk of acute urinary retention and BPH-related surgery.
Target Markets
Our Tamsulosin MR + Finasteride combination is manufactured for domestic and international markets including:
- Asia-Pacific
- Africa
- Middle East
- CIS Countries
- Latin America
- Eastern Europe
All products meet the quality and regulatory guidelines specific to the country of export, ensuring seamless registration and market acceptance.
Manufacturing Infrastructure at BluepillExpress
1. WHO-GMP Certified Facilities
BluepillExpress operates out of state-of-the-art manufacturing plants that are WHO-GMP certified and compliant with other global accreditations such as ISO 9001:2015, US FDA (where applicable), and EU-GMP standards.
2. Dedicated Production Zones
Our facilities maintain segregated manufacturing lines for hormonal and non-hormonal products, beta-lactams, modified-release formulations, and high-potency APIs to avoid cross-contamination and ensure product integrity.
3. Modified-Release Expertise
Formulating modified-release drugs requires scientific sophistication. Our pharmaceutical R&D and formulation scientists are highly skilled in designing polymer-coated granules, osmotic-controlled release systems, and matrix-based tablets to deliver precise pharmacokinetics for Tamsulosin MR.
Formulation Development & Technology
The development of a fixed-dose combination of Tamsulosin MR and Finasteride demands careful attention to:
- Dissolution profiles
- Drug-drug interaction control
- Bioavailability enhancement
- pH-independent drug release
We utilize advanced excipients, enteric coatings, and controlled-release polymers to ensure that Tamsulosin is released gradually, while Finasteride is absorbed efficiently, providing full therapeutic benefit.
Our R&D team works closely with our partners to customize:
- Dissolution profiles
- Taste-masking features
- Tablet size and shape
- Packaging compatibility
Quality Assurance and Quality Control
BluepillExpress adheres to the most stringent QA/QC protocols at every step of production:
1. Raw Material Sourcing
We procure APIs and excipients from certified and audited vendors who meet pharmacopeial standards such as USP, BP, EP, and IP.
2. In-Process Control
Each batch undergoes continuous in-process testing including:
- Blend uniformity
- Granule flow properties
- Compression force monitoring
- Coating thickness consistency
3. Finished Product Testing
Our QC labs conduct a wide array of tests including:
- Assay and Content Uniformity
- Dissolution Testing
- Impurity Profiling (HPLC/GC)
- Microbiological Testing
- Stability Testing under ICH Guidelines
Packaging & Labeling Solutions
We offer a variety of packaging options to cater to your brand’s requirements and market compliance:
- Alu-Alu Blisters – For high humidity protection
- PVC Blisters – Cost-effective and widely accepted
- HDPE Bottles – For bulk packaging
- Custom Labels & Designs – In multiple languages and regulatory formats
Tamper-proof, patient-friendly, and regulatory-compliant packaging are guaranteed with every order.
Regulatory Support
Our dedicated Regulatory Affairs team supports our partners with:
- Product Dossiers (CTD/eCTD)
- COA, COPP, Stability Data
- DMF (if applicable)
- BE Studies and Technical Files
- Assistance with product registration
We understand the complexities of international pharmaceutical regulations and work closely with our clients to ensure that all documentation is provided in a timely and compliant manner.
Why Partner with BluepillExpress?
1. Customization and Scalability
Whether you’re a startup seeking small batches or an established pharma company requiring large-scale manufacturing, BluepillExpress offers flexible batch sizes and custom formulations tailored to your needs.
2. End-to-End Services
From formulation to packaging and export documentation, our turnkey third-party manufacturing solutions allow you to focus on marketing and distribution while we manage production.
3. Affordable Pricing
Our economies of scale, efficient processes, and in-house capabilities allow us to offer cost-effective pricing without compromising on quality.
4. Transparent Communication
We maintain transparent, collaborative communication throughout the manufacturing lifecycle, from planning and production to batch release and dispatch.
5. Global Reach
With a strong global supply chain network, BluepillExpress successfully delivers pharmaceutical products to over 40+ countries across continents, complying with each country’s regulatory landscape.
Minimum Order Quantities (MOQ)
We support both low and high-volume clients. Standard MOQ for Tamsulosin MR + Finasteride is typically:
- 10,000 tablets per order, depending on the packaging and formulation.
- Customized MOQ options available based on product portfolio and commitment terms.
Confidentiality and IP Protection
BluepillExpress signs Non-Disclosure Agreements (NDAs) and Confidentiality Clauses to safeguard the interests and intellectual property of all our clients. Our processes ensure that your product specifications and business strategies remain secure.
Conclusion
Tamsulosin Hydrochloride (Modified Release) & Finasteride is a widely prescribed combination therapy offering long-term benefits for patients with BPH. At BluepillExpress, we are proud to offer third-party manufacturing services that uphold the highest quality standards, regulatory compliance, and scientific innovation required for such sophisticated formulations.
From advanced MR formulation capabilities to comprehensive regulatory support and flexible production capacities, BluepillExpress is your ideal manufacturing partner for expanding your pharmaceutical portfolio with trusted and effective urology therapies.
