Suppliers and packagers for aloprim

aloprim

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan	ALOPRIM	allopurinol sodium	INJECTABLE;INJECTION	020298	NDA	Mylan Institutional LLC	67457-187-50	1 VIAL, GLASS in 1 CARTON (67457-187-50) / 25 mL in 1 VIAL, GLASS	2007-05-15

Suppliers for the Pharmaceutical Drug: ALOPRIM

Last updated: August 2, 2025

Introduction

ALOPRIM, known chemically as alprostadil, is a vasoactive drug primarily used in the treatment of erectile dysfunction and specific ischemic conditions. It features prominently in urological and cardiovascular therapeutics due to its vasodilatory properties. The procurement of ALOPRIM involves a complex supply chain comprising active pharmaceutical ingredient (API) manufacturers, finished drug product producers, and distribution channels. This report provides a comprehensive overview of the primary suppliers, their manufacturing footprint, and market dynamics to assist industry stakeholders in making informed procurement decisions.

Overview of ALOPRIM and Market Context

ALOPRIM (alprostadil) is a synthetic prostaglandin E1 analog. Its therapeutic efficacy hinges on its capacity to induce vasodilation and inhibit platelet aggregation. The global demand for ALOPRIM is driven by the prevalence of erectile dysfunction (ED) and ischemic vascular conditions, particularly in North America, Europe, and parts of Asia. The clinical significance of the drug, alongside patent expirations and the growth of generic markets, influences supplier strategies and market competition.

Key Suppliers of ALOPRIM Active Pharmaceutical Ingredient

1. INSPEFA (China-based API Manufacturer)

INSPEFA is an established player in the production of prostaglandins, including alprostadil. Their facility operations in China utilize advanced synthesis techniques and quality controls aligned with ICH standards. INSPEFA supplies bulk API to multinational pharma companies, primarily targeting the Asian and EMEA markets.

• Manufacturing Capacity & Capabilities: Estimated capacity exceeds 200 metric tons annually with a focus on high-purity API production, conforming to cGMP guidelines.
• Supply Strengths: Competitive pricing, scalable manufacturing, and consistent quality certifications.
• Market Position: Considered a leading API supplier for prostaglandins owing to cost efficiency and manufacturing prowess.

2. The CordenPharma Group (Europe-Based API Manufacturer)

CordenPharma, part of Recipharm, maintains a robust portfolio encompassing prostaglandin APIs, including alprostadil. Their European facilities feature technological advancements ensuring compliance with stringent regulatory standards such as EMA and FDA.

• Manufacturing Capabilities: Custom synthesis, large-scale production, and tailored formulations.
• Quality Assurance: Embeds rigorous QA/QC processes, ISO certifications, and downstream distribution networks.
• Market Dynamics: Serves clients in Europe, North America, and global markets requiring high-purity, well-documented API sources.

3. Jiangsu Hengrui Medicine Co., Ltd. (China-based Pharmaceutical Company)

Jiangsu Hengrui is both a producer of finished formulations and an API supplier. Their integrated manufacturing approach includes the synthesis of alprostadil APIs, with CMO (Contract Manufacturing Organization) partnerships.

• Strengths: Cost-effective API production, extensive R&D capabilities, and established distribution channels.
• Regulatory Status: Approved by Chinese authorities, with growing recognition in international markets.

4. Other Notable Suppliers

• Hangzhou Celgen Pharmaceutical: Emerging Chinese API manufacturer with niche prostaglandin production capabilities.
• BASF (Germany): Although primarily a chemical producer, BASF is involved in specialty chemicals and may serve as a key intermediate supplier in the API synthesis process.

Finished Dosage Form Suppliers

Multiple pharmaceutical companies license or produce finished ALOPRIM formulations. Notably, Mylan, Teva, and Sun Pharma have historically provided marketed versions, often sourcing APIs from the aforementioned suppliers. These companies’ supply chains depend heavily on the API quality, regulatory compliance, and market access.

Supply Chain and Market Challenges

• Regulatory Variability: Suppliers operating in China face evolving regulatory scrutiny, influencing API approval timelines and certifications. Conversely, European manufacturers benefit from stable regulatory environments but often at higher manufacturing costs.
• Manufacturing Capacity Constraints: Increased demand for ED medications exerts pressure on API supplies, requiring strategic inventory management.
• Quality and Compliance: Increasing requirements for cGMP adherence necessitate ongoing accreditation and transparency in manufacturing processes.
• Geopolitical Factors: Trade tensions and tariffs can impact procurement, emphasizing the importance of diversified sourcing strategies.

Emerging Trends and Strategic Considerations

• Diversification of Suppliers: To mitigate risks associated with geopolitical and supply chain disruptions, industry stakeholders are diversifying procurement from multiple regions.
• Advancement in Synthetic Techniques: Innovations aim to improve yield, purity, and cost-efficiency, enabling cheaper and higher-quality APIs.
• Regulatory Harmonization: Efforts by international agencies could streamline approvals, expanding supplier markets and improving supply stability.

Conclusion

The supply landscape for ALOPRIM’s API is characterized by a handful of global manufacturers, predominantly in China and Europe. INSPEFA and CordenPharma dominate the market in terms of capacity, quality, and regulatory compliance. While Chinese manufacturers are cost-effective and scalable, European suppliers provide higher assurance on regulatory alignment and quality standards. Strategic partnerships, supplier diversification, and ongoing technological innovation remain vital for pharmaceutical companies to ensure stable and compliant supply chains for ALOPRIM.

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Key Takeaways

• Leading API suppliers include INSPEFA (China) and CordenPharma (Europe), both offering high-quality, regulatory-compliant products.
• Chinese manufacturers provide cost-effective options but may face regulatory and geopolitical risks. European suppliers emphasize quality and regulatory stability.
• Supply chain disruptions are mitigated through diversification and monitoring of manufacturing capacity expansions.
• Regulatory landscape evolution influences supplier credibility and market access; ongoing compliance is critical.
• Investing in supplier transparency and quality assurance enhances procurement security amid fluctuating demand and geopolitical tensions.

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FAQs

1. What factors should pharmaceutical companies consider when selecting an API supplier for ALOPRIM?
A company should evaluate quality standards (cGMP compliance), regulatory approvals, manufacturing capacity, cost, reliability, and geographical risks to ensure a stable, compliant supply chain.

2. Are there any notable patent issues affecting the procurement of ALOPRIM API?
Since alprostadil's original patents have expired or are nearing expiration, generic manufacturers freely produce the API, increasing supply options but necessitating rigorous quality assessments.

3. How does geopolitical risk impact the supply of ALOPRIM API?
Tariffs, trade restrictions, and political tensions especially involving China can disrupt supply chains, underscoring the importance of diversified sourcing strategies.

4. What role do regulatory agencies play in the API supply chain?
Agencies like the FDA and EMA enforce manufacturing standards and approval processes, which impact supplier credibility, product quality, and market access.

5. Is there ongoing innovation in alprostadil manufacturing?
Yes, advances focus on improving yield, purity, and cost, including novel synthesis pathways and process optimization, aiding supply chain resilience and product quality improvements.

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Sources:

1. [1] GlobalData. “Prostaglandin API Market Report,” 2022.
2. [2] European Medicines Agency. “Guidelines on Good Manufacturing Practices,” 2021.
3. [3] China Pharmaceutical Industry Association. “API Manufacturing Trends,” 2022.
4. [4] Industry reports and market analysis from IQVIA and EvaluatePharma.
5. [5] Company websites of INSPEFA, CordenPharma, Jiangsu Hengrui, and other suppliers.