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Flutamide

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Flutamide is a nonsteroidal antiandrogen that plays a crucial role in the treatment of prostate cancer and certain other androgen-dependent conditions. At BluepillExpress, we provide comprehensive third-party manufacturing services for Flutamide that are built on quality assurance, regulatory compliance, and global distribution capabilities. As a leading pharmaceutical exporter and manufacturer, BluepillExpress is your reliable partner for custom formulation, bulk manufacturing, and private labeling of Flutamide tablets.

This document outlines the capabilities, standards, and comprehensive third-party manufacturing services offered by BluepillExpress for Flutamide, catering to pharmaceutical brands, wholesalers, hospitals, clinics, and distributors across the globe.

Product Overview: Flutamide

  • Therapeutic Class: Nonsteroidal Antiandrogen
  • Form Available: Tablet
  • Strengths Offered: Common strengths include 125 mg and 250 mg (customization available)
  • Indications: Primarily used in the treatment of advanced prostate cancer, often as part of combination therapy with GnRH analogs.
  • Mechanism of Action: Flutamide works by inhibiting the uptake and binding of androgens (testosterone and dihydrotestosterone) in prostate tissue, thereby limiting cancer cell growth.

Why Choose BluepillExpress for Flutamide Manufacturing?

  1. GMP and WHO-Certified Facilities
    Our manufacturing plants are fully compliant with Good Manufacturing Practices (GMP), World Health Organization (WHO) standards, and other international regulatory norms such as USFDA, EU-GMP, TGA, and more. We adhere to strict protocols in the production of Flutamide, ensuring purity, safety, and efficacy.
  2. High-Precision Manufacturing
    Our infrastructure includes advanced blending, granulation, compression, and coating equipment that ensure uniform dosage, consistent batch quality, and accurate drug delivery mechanisms for Flutamide.
  3. Stringent Quality Assurance
    Quality is the cornerstone of our operations. Each batch of Flutamide undergoes rigorous in-process checks, stability testing, microbial testing, and final product verification to meet pharmacopeial specifications (USP/BP/EP/IP).
  4. Customized Formulation and Packaging
    We offer a wide array of customized services including:
    • Custom dosage formulations (125 mg, 250 mg, etc.)
    • Branded or generic labeling
    • Strip, blister, or bottle packaging options
    • Multilingual printing as per export destination
    • Eco-friendly packaging solutions
  5. Export-Oriented Approach
    With decades of experience in international logistics and pharmaceutical regulations, BluepillExpress provides full export documentation including Certificate of Analysis (COA), MSDS, COPP, Free Sale Certificates, and Legalized Documents (via embassy or consulate) for smooth global trade.

Manufacturing Capabilities and Process Workflow

  1. Raw Material Sourcing
    We procure high-grade Active Pharmaceutical Ingredients (APIs) and excipients for Flutamide from certified and reputable global suppliers. Each raw material is tested and approved by our quality team before use.
  2. Formulation Development
    Our R&D and formulation experts ensure the optimal composition of excipients and binders for effective drug release. For clients needing novel drug delivery systems or extended-release formulations, we offer contract R&D services.
  3. Granulation and Blending
    Wet or dry granulation is performed depending on the formulation specifics, followed by precision blending in controlled environments to maintain batch consistency.
  4. Compression and Coating
    Our automated tablet compression machines guarantee uniform weight and hardness for Flutamide tablets. Coating can be customized for taste masking, color coding, or extended-release.
  5. Packaging and Labeling
    Final products are packed in tamper-proof and protective packaging options such as alu-alu blister packs, PVC blisters, or HDPE bottles. Labels are designed per client’s branding and regional compliance standards.
  6. Storage and Dispatch
    Products are stored in temperature-controlled warehouses and dispatched via trusted logistic partners to ensure timely and safe delivery worldwide.

Flutamide Product Specifications (Typical)

ParameterSpecification
AppearanceWhite to off-white tablet
Strength125 mg / 250 mg (customizable)
PackagingBlister pack / Strip / Bottle
Shelf Life24 to 36 months
Storage ConditionsBelow 25°C, protect from moisture
Regulatory StandardsIP/BP/USP/EP compliant
Batch SizeFrom 10,000 tablets to commercial scale

Contract Manufacturing Models at BluepillExpress

We offer flexible manufacturing engagement models to suit the needs of pharmaceutical brands and institutional buyers:

  1. White Label Manufacturing
    • We manufacture Flutamide tablets which you can sell under your own brand name.
    • Ideal for distributors and marketing companies.
  2. Private Label Manufacturing
    • Customized packaging and branding as per your requirement.
    • End-to-end branding support from logo to label design.
  3. Loan License Manufacturing
    • Suitable for companies with existing marketing licenses who need a trusted manufacturer.
    • We handle production, packaging, and quality assurance.
  4. Dedicated Production
    • Reserved manufacturing slots and machinery allocation for high-volume partners.
    • Useful for clients with recurring, high-quantity orders.

Compliance and Certifications

Our Flutamide manufacturing process is supported by a wide array of regulatory approvals and certifications:

  • WHO-GMP Certification
  • ISO 9001:2015 Certified
  • FSSAI License (for nutraceutical lines)
  • PIC/S-compliant facility
  • Approved by Drug Control General of India (DCGI)
  • Vendor audit-ready documentation for client review

We also assist international clients in registration dossiers, bioequivalence studies, and submission documentation for local market approvals.

Industries and Markets We Serve

BluepillExpress proudly serves clients in the following markets:

  • Domestic Indian Market: Marketing firms and hospital procurement
  • Africa: Nigeria, Ghana, Kenya, South Africa
  • Middle East: UAE, Saudi Arabia, Iraq
  • Asia: Vietnam, Philippines, Cambodia, Sri Lanka
  • Europe and CIS: Ukraine, Georgia, Armenia
  • South America and Caribbean: Ecuador, Chile, Dominican Republic
  • USA and Canada: For dietary/nutraceutical export under appropriate categories

Client Support and Value-Added Services

At BluepillExpress, our mission extends beyond manufacturing. We offer a complete suite of value-added services, including:

  • Regulatory Documentation Assistance
  • Customs Clearance Support
  • Artwork Design and Branding
  • Third-Party Lab Testing Reports
  • Logistics and Freight Management
  • Repacking and Relabeling Services

Our dedicated project management team ensures seamless coordination across every phase of your order — from formulation to final delivery.

Sustainability and Environmental Compliance

BluepillExpress follows eco-friendly manufacturing practices that minimize environmental impact:

  • Waste disposal in compliance with pollution control norms
  • Use of energy-efficient machinery and HVAC systems
  • Recyclable packaging materials
  • Water-saving technologies in production and cleaning processes

Partner with BluepillExpress for Flutamide Manufacturing

With a reputation for excellence, dependability, and regulatory integrity, BluepillExpress invites pharmaceutical companies, marketers, and distributors to partner with us for the third-party manufacturing of Flutamide. Whether you’re launching a new brand or expanding an existing portfolio, our solutions are scalable, cost-effective, and backed by scientific rigor.

We ensure that your brand stands out in a competitive market by delivering products that meet global expectations in quality, safety, and therapeutic efficacy.

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