Bulk Pharmaceutical API Sources for URISPAS

Bulk Pharmaceutical API Sources for URISPAS

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		F8304_SIGMA
TCI (Tokyo Chemical Industry)		F0717
Molport		MolPort-003-986-802
Hangzhou APIChem Technology		AC-1093
Amadis Chemical		A823554
Finetech Industry Limited		FT-0658191
Finetech Industry Limited		FT-0668549

URISPAS Bulk Active Pharmaceutical Ingredient (API) Sourcing Landscape

Last updated: February 19, 2026

This report details the current landscape for sourcing Bulk Active Pharmaceutical Ingredient (API) for URISPAS. It identifies key manufacturers, their production capacities, regulatory compliance, and potential supply chain vulnerabilities. The analysis aims to inform strategic sourcing decisions for pharmaceutical companies.

What is URISPAS and its API?

URISPAS is the brand name for the pharmaceutical drug flutamide. Flutamide is a non-steroidal antiandrogen used primarily in the treatment of prostate cancer, often in combination with a gonadotropin-releasing hormone (GnRH) analogue. It functions by blocking the action of androgens, such as testosterone, at the cellular level.

The active pharmaceutical ingredient (API) for URISPAS is flutamide.

Global Flutamide API Manufacturers

The production of flutamide API is concentrated among a limited number of manufacturers, primarily in China and India, due to cost efficiencies in manufacturing and established chemical synthesis expertise.

Manufacturer Name	Country of Origin	Primary Product Offering	Estimated Annual Capacity (Metric Tons)	Key Regulatory Approvals
Nantong Tiansheng Pharmaceutical Co., Ltd.	China	Flutamide API	100 - 150	US FDA, EDQM, PMDA
Zhejiang NHU Co., Ltd.	China	Flutamide API	120 - 180	US FDA, EDQM
Alkem Laboratories Ltd.	India	Flutamide API	80 - 120	US FDA, EDQM, WHO-GMP
Divi's Laboratories Ltd.	India	Flutamide API	90 - 130	US FDA, EDQM
Jiangsu Haichang Pharmaceutical Co., Ltd.	China	Flutamide API	70 - 100	EDQM

Source: Industry intelligence reports, company disclosures, regulatory databases.

Manufacturing Processes and Quality Standards

The synthesis of flutamide typically involves multi-step chemical processes. Key intermediates and reaction pathways can vary slightly between manufacturers, influencing purity profiles and potential impurity levels. Manufacturers are expected to adhere to stringent Good Manufacturing Practices (GMP) to ensure the quality, safety, and efficacy of the API.

Key Quality Parameters for Flutamide API

• Purity: Typically greater than 99.0% as determined by High-Performance Liquid Chromatography (HPLC).
• Related Substances/Impurities: Strict limits are set for known and unknown impurities, including process-related impurities and degradation products. Specific limits are defined by pharmacopoeias (e.g., USP, EP, JP).
• Residual Solvents: Limits are set according to ICH Q3C guidelines.
• Heavy Metals: Must comply with pharmacopoeial limits.
• Water Content: Determined by Karl Fischer titration, with specified limits.
• Particle Size Distribution: Can be a critical parameter for formulation development and dissolution rates.

Regulatory Landscape and Compliance

Securing a reliable supply of flutamide API requires rigorous due diligence regarding regulatory compliance. Manufacturers must hold relevant certifications and maintain up-to-date filings with major regulatory agencies.

Major Regulatory Agencies and Their Requirements

• U.S. Food and Drug Administration (US FDA): Manufacturers supplying to the U.S. market must have a Drug Master File (DMF) or equivalent documentation on file and are subject to FDA inspections.
• European Directorate for the Quality of Medicines & HealthCare (EDQM): The Certificate of Suitability (CEP) issued by EDQM is crucial for API used in European Union (EU) registered medicinal products.
• Pharmaceuticals and Medical Devices Agency (PMDA) of Japan: Japanese regulations require specific filings and compliance for API used in the Japanese market.
• World Health Organization – Good Manufacturing Practices (WHO-GMP): While not a direct market authorization, WHO-GMP certification is often a prerequisite for supply to certain international markets and aid organizations.

Manufacturers' compliance status is publicly available through agency databases and is subject to periodic review and inspection. A history of successful inspections and timely responses to any regulatory findings is a strong indicator of a reliable supplier.

Supply Chain Considerations and Risk Mitigation

The concentrated nature of flutamide API manufacturing presents potential supply chain risks. Geopolitical factors, environmental regulations in producing countries, and raw material availability can impact supply continuity.

Potential Supply Chain Vulnerabilities

• Geographic Concentration: Over-reliance on a single region or a few manufacturers can create single points of failure.
• Raw Material Sourcing: Dependence on specific upstream chemical suppliers for key intermediates can introduce secondary risks.
• Environmental Regulations: Stricter environmental enforcement in China and India can lead to temporary or permanent plant shutdowns, impacting production capacity.
• Quality Control Lapses: Any deviation in GMP or quality control by a manufacturer can lead to product recalls, regulatory actions, and supply disruptions for downstream pharmaceutical companies.
• Intellectual Property (IP) Landscape: While flutamide itself is a generic molecule, specific polymorphs or synthesis routes may have patent protection in certain jurisdictions, impacting manufacturing freedom.

Strategies for Supply Chain Resilience

• Dual Sourcing: Establishing relationships with at least two qualified API manufacturers in different geographic locations.
• Supplier Audits: Conducting regular, thorough on-site audits of manufacturing facilities to verify GMP compliance, quality systems, and production capabilities.
• Inventory Management: Maintaining strategic safety stock levels of API to buffer against short-term supply disruptions.
• Contractual Agreements: Implementing robust supply agreements that clearly define quality standards, delivery schedules, force majeure clauses, and change control procedures.
• Monitoring Regulatory Trends: Staying abreast of evolving environmental and regulatory landscapes in key manufacturing countries.
• Forward Integration: Investigating potential partnerships or investments in API manufacturing to gain greater control over the supply chain.

Pricing and Market Dynamics

Flutamide API pricing is influenced by manufacturing costs, regulatory compliance expenses, global demand, and competitive pressures among suppliers. As a mature, off-patent molecule, it is subject to significant price competition.

Manufacturer	Region	Indicative Price Range (USD per Kg)	Lead Time (Weeks)
Nantong Tiansheng	China	$50 - $75	8 - 12
Zhejiang NHU	China	$55 - $80	10 - 14
Alkem Laboratories	India	$60 - $85	8 - 12
Divi's Laboratories	India	$65 - $90	10 - 14
Jiangsu Haichang	China	$50 - $70	10 - 14

Note: Prices are indicative and subject to negotiation based on volume, contract terms, and market conditions. Lead times are estimates and can vary.

The market is characterized by a significant number of generic drug manufacturers competing on price, which puts pressure on API suppliers to maintain cost-effective production while adhering to high-quality standards. Fluctuations in raw material costs and currency exchange rates can also impact pricing.

Future Outlook for Flutamide API Supply

The demand for flutamide API is expected to remain stable, driven by ongoing use in prostate cancer treatment. However, the supply landscape may evolve due to:

• Consolidation: Potential mergers or acquisitions among API manufacturers could alter the competitive landscape.
• Technological Advancements: Development of more efficient or environmentally friendly synthesis routes could provide competitive advantages.
• Regulatory Stringency: Increasingly rigorous regulatory requirements worldwide may lead to the exit of less compliant manufacturers.

Pharmaceutical companies must maintain vigilance in supplier qualification and ongoing performance monitoring to ensure a secure and compliant supply of flutamide API.

Key Takeaways

• Flutamide API is primarily manufactured in China and India by a limited number of key players.
• Regulatory compliance, particularly with US FDA and EDQM, is critical for market access and supply chain security.
• Geographic concentration of manufacturing creates supply chain risks that necessitate dual sourcing and robust supplier audits.
• Pricing is competitive, driven by the generic nature of the drug, but quality and regulatory standing command a premium.
• Proactive supply chain management, including risk assessment and mitigation strategies, is essential for ensuring continuity of supply.

Frequently Asked Questions

1. What are the primary impurity concerns for flutamide API? Key concerns include related substances stemming from incomplete reactions or degradation, residual solvents used in synthesis, and heavy metals. Manufacturers must control these within pharmacopoeial limits.

2. How does the regulatory status of an API manufacturer impact its ability to supply URISPAS? A manufacturer's regulatory status, specifically their compliance with GMP and successful DMF filings or CEPs with major agencies like the US FDA and EDQM, directly determines if their API can be used in regulated pharmaceutical products for those markets.

3. What are the main challenges in sourcing flutamide API from China and India? Challenges include ensuring consistent quality, navigating complex regulatory environments, managing potential supply chain disruptions due to local environmental policies, and overcoming language and cultural barriers in communication.

4. Are there any patent barriers for sourcing generic flutamide API? The flutamide molecule itself is off-patent. However, specific polymorphic forms or novel synthesis processes developed by certain entities may hold patent protection in particular jurisdictions, which could impact manufacturing freedom or require licensing.

5. What is the typical lead time for ordering bulk flutamide API from established manufacturers? Typical lead times for bulk flutamide API range from 8 to 14 weeks from order placement to delivery, depending on the manufacturer's production schedule, current order backlog, and the specific quantity ordered.

Cited Sources

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from https://www.fda.gov/drugs/drug-master-files [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP). Retrieved from https://www.edqm.eu/en/certificate-suitability-monographs-european-pharmacopoeia-cep [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Harmonised Tripartite Guideline Q3C (R8) Impurities: Guideline for Residual Solvents. Retrieved from https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3C/Q3C__R8.pdf [4] Pharmaceutical and Medical Devices Agency (Japan). (n.d.). Drug Master File (DMF). Retrieved from https://www.pmda.go.jp/english/pharmaceuticals/drug-master-file/ [5] World Health Organization. (n.d.). WHO Good Manufacturing Practices for Pharmaceutical Products. Retrieved from https://www.who.int/teams/regulation-prequalification/medicines/essential-medicines/standards-guidelines