DURATIA 90

Duratia 90 (Dapoxetine 90 mg) is a high-strength prescription medication widely used to manage premature ejaculation (PE) in men. As the demand for PE treatments grows globally, many pharmaceutical companies are looking to expand their product lines with reliable, high-quality brands like Duratia 90. If you’re considering adding Duratia 90 to your portfolio, third-party or contract manufacturing offers a cost-effective, scalable, and compliant solution.

This comprehensive guide explores everything you need to know about third-party manufacturing Duratia 90: from understanding the formulation to selecting a manufacturing partner, complying with quality standards, and effectively launching the product.

Understanding Duratia 90

Duratia 90 contains Dapoxetine Hydrochloride, a selective serotonin reuptake inhibitor (SSRI) developed specifically for on-demand treatment of premature ejaculation in men aged 18–64. Its rapid onset of action (30-60 minutes) and short half-life reduce long-term side effects while providing effective control of ejaculation.

Duratia 90 is typically prescribed when lower doses (e.g., 30 mg, 60 mg) are insufficient, offering more potent symptom relief for severe PE cases.

Why Choose Third-Party Manufacturing for Duratia 90?

Third-party manufacturing—also known as contract manufacturing—enables companies to outsource the production of Duratia 90 tablets to specialized GMP-certified manufacturers. This model offers numerous advantages:

Cost savings – Avoid investing in expensive production facilities, machinery, or skilled labor.
Expertise – Partnering with an experienced manufacturer ensures consistent product quality and regulatory compliance.
Scalability – Easily adjust production volumes based on market demand without disrupting operations.
Focus – Concentrate on core activities like marketing, distribution, and brand building while manufacturing experts handle production.

Key Specifications for Duratia 90 Manufacturing

To manufacture Duratia 90 with a third-party partner, you need precise technical and regulatory specifications. A typical Duratia 90 tablet involves:

• Active Pharmaceutical Ingredient (API): Dapoxetine Hydrochloride 90 mg
• Dosage Form: Oral tablet, film-coated for better patient compliance
• Excipients: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and other pharmaceutically approved agents
• Tablet Characteristics: Round, biconvex, standard color coding, blister or strip packaging
• Packaging Options: Alu-Alu or PVC blister packs in cardboard cartons; secondary packaging as per client’s branding

Your contract manufacturer will develop a formulation dossier containing all technical data, including stability studies, analytical methods, and process validations.

Choosing a Third-Party Manufacturer for Duratia 90

Selecting the right manufacturer is critical to the success of your Duratia 90 brand. Here’s what to look for:

GMP/WHO-GMP Compliance: Ensure the facility follows international Good Manufacturing Practices.
ISO Certification: Demonstrates adherence to global quality management systems.
Experience: Choose manufacturers with proven expertise in PE or urology segments.
Production Capacity: Verify they can handle your projected volumes without compromising timelines.
Regulatory Support: The best manufacturers assist with documentation for registration or market authorization in your target countries.
Customization: Ability to customize tablet design, packaging, and branding to match your company’s needs.

Popular pharma manufacturing hubs like India, China, and parts of Europe offer competitive pricing, but always perform audits to check infrastructure, equipment, and quality processes.

5. Process Flow: Third-Party Manufacturing of Duratia 90

A typical third-party manufacturing process follows these steps:

Request for Quotation (RFQ): Share product specifications with shortlisted manufacturers and request a detailed quotation.
Cost & Agreement: Finalize price, minimum order quantity (MOQ), payment terms, and timelines. Sign a legally binding manufacturing agreement.
Artwork & Branding: Submit artwork for packaging. Manufacturers usually provide dielines and design support.
Sample Approval: Manufacturer develops initial trial batches for your approval. Adjustments can be made at this stage.
Commercial Production: Once samples are approved, commercial-scale batches are manufactured under strict GMP guidelines.
Quality Control & Assurance: Finished products undergo in-house and, if needed, third-party lab testing for API content, dissolution, stability, and microbial limits.
Dispatch: Approved batches are packaged, labeled, and shipped to your warehouse or distribution partners.

Quality Standards and Compliance

Duratia 90, being a prescription-only medicine, must meet stringent quality benchmarks:

• API Purity: Dapoxetine should meet pharmacopeial standards (USP, EP, IP).
• Tablet Uniformity: Consistent weight, thickness, and hardness across batches.
• Dissolution Profile: Tablets must release the API within specified timeframes.
• Stability: Long-term and accelerated stability studies to ensure shelf life.

Always request certificates of analysis (CoA), batch manufacturing records, and stability data from your manufacturer.

Branding, Packaging, and Labeling

Packaging is not just functional but a vital marketing tool. For Duratia 90:

• Choose attractive, tamper-evident blister packs.
• Use professional-grade cartons with clear dosage and caution labels.
• Include package inserts with dosage, warnings, contraindications, and instructions for patient use.
• Consider adding QR codes for digital marketing or patient education.

A good third-party manufacturer will offer end-to-end support, from packaging design to final packing.

Legal and Regulatory Considerations

Before launching Duratia 90 in any market:

• Check local regulatory frameworks. In India, file under the Central Drugs Standard Control Organization (CDSCO); in the EU, comply with EMA guidelines; in the US, ensure FDA compliance if marketing generics.
• Secure product registration, import licenses (if sourcing internationally), and marketing authorizations.
• Maintain proper pharmacovigilance systems for adverse event reporting.

Marketing & Distribution Support

Leading third-party manufacturers offer value-added services, including:

• Assistance in creating promotional materials like brochures, doctor samples, and visual aids.
• Market insights on competitor pricing, market size, and regulatory hurdles.
• Logistic support for domestic or international shipping.

Conclusion

Third-party manufacturing of Duratia 90 is a smart, efficient way to introduce a premium, high-strength PE treatment to your portfolio without heavy investment. By partnering with a reliable, GMP-certified manufacturer, you can ensure consistent quality, timely delivery, and regulatory compliance—allowing you to focus on growing your brand and capturing market share.