Suppliers and packagers for generic pharmaceutical drug: TERLIPRESSIN ACETATE

TERLIPRESSIN ACETATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231	NDA	Mallinckrodt Hospital Products Inc.	43825-200-01	1 VIAL, SINGLE-DOSE in 1 CARTON (43825-200-01) / 5 mL in 1 VIAL, SINGLE-DOSE	2022-09-14

Suppliers for the Pharmaceutical Drug: Terlipressin Acetate

Last updated: July 29, 2025

Introduction

Terlipressin acetate is a synthetic vasopressin analog primarily used in the management of hepatorenal syndrome, variceal bleeding, and severe bleeding episodes associated with cirrhosis. Its pivotal role in critical care necessitates a reliable supply chain comprising reputable manufacturers and distributors. This article explores the leading suppliers of terlipressin acetate, examining their market presence, regulatory compliance, and global distribution capabilities, providing healthcare professionals and procurement specialists with strategic insights.

Overview of Terlipressin Acetate

Terlipressin acetate functions as a vasoconstrictor by stimulating vasopressin receptor subtypes, notably V1 receptors, leading to increased systemic vascular resistance. It is available in various formulations, including lyophilized powder for reconstitution, and is primarily administered intravenously under strict medical supervision. Its manufacturing involves complex chemical synthesis, demanding high-quality standards and regulatory adherence, which only certain pharmaceutical players can fulfill.

Leading Suppliers in the Global Market

Numerous manufacturers have emerged as key suppliers, with some operating under stringent regulatory approvals and others focusing on regional markets. The following provides an in-depth analysis of notable suppliers:

1. Ferring Pharmaceuticals

Market Presence & Regulatory Status Ferring Pharmaceuticals is a global leader in reproductive and specialized medicine, including vasopressin analogs. The company markets Terlipressin under the trade name Terliv in select regions, especially Europe and Asia. Regulatory approvals are secured through stringent agencies such as EMA (European Medicines Agency) and others, facilitating broad distribution.

Production & Supply Capabilities Ferring maintains advanced manufacturing facilities compliant with Good Manufacturing Practices (GMP). Its global supply network extends across Europe, Asia, and Latin America, ensuring reliable availability.

2. Fuzhou Suncon Pharmaceutical Co., Ltd.

Regional Focus & Market Share Based in China, Fuzhou Suncon Pharmaceutical specializes in the synthesis of peptide-based pharmaceuticals, including terlipressin acetate. The company is recognized for its cost-effective manufacturing and has obtained Chinese regulatory approval.

Regulatory & Export Capacity While primarily serving the domestic Chinese market, Fuzhou Suncon has expanded exports to Southeast Asia and parts of Africa, leveraging regional pharmaceutical trade agreements.

3. Cadila Healthcare (Zydus Cadila)

Product Portfolio & Approvals Zydus Cadila, an Indian pharmaceutical giant, manufactures terlipressin acetate for hospital use within India and for export to regions with regulatory approvals. The company emphasizes high-quality standards, adhering to Indian GMP standards aligned with WHO guidelines.

Distribution Network Zydus has an extensive distribution network across Asia, the Middle East, and emerging markets, providing a strategic supply chain for critical care drugs.

4. Wockhardt Ltd.

Manufacturer & Regional Reach Wockhardt, another prominent Indian pharmaceutical producer, offers terlipressin acetate formulations supplied mainly to hospitals and clinics in India and select international markets. The firm is known for its robust R&D capabilities and GMP compliance.

Regulatory Compliance The company holds necessary approvals from the Drugs Controller General of India (DCGI) and has attained some international certifications facilitating export.

5. MANNARIN BIOSCIENCE

Emerging Player & Niche Markets A newer entrant with facilities in Asia, MANNARIN BIOSCIENCE supplies terlipressin acetate primarily within local markets, emphasizing affordability and quality. Their GMP-certified manufacturing processes meet international standards, positioning them for broader export.

Supply & Reliability Reliability remains an area of focus, with ongoing investments in capacity expansion to meet growing global demands, especially amidst shortages.

Regulatory and Quality Considerations

Quality assurance is paramount in sourcing terlipressin acetate, given its critical application in intensive care settings. Suppliers compliant with agencies such as the US FDA, EMA, and WHO prequalification criteria tend to offer higher reliability and assurance of product quality. Healthcare providers must carefully verify regulatory approvals, manufacturing practices, and batch-certification documentation before procurement.

Market Trends & Challenges

The supply of terlipressin acetate has experienced volatility, partly due to regional manufacturing constraints and regulatory hurdles. The global shortage has prompted healthcare providers to explore alternative vasoconstrictors or biosimilar options, emphasizing the importance of diversified supplier portfolios.

Furthermore, patent expirations and the emergence of generic manufacturers have influenced competitive pricing and availability. Nevertheless, quality remains a critical concern for procurement, steering preference toward established, regulatory-compliant suppliers.

Key Takeaways

• Leading suppliers include Ferring Pharmaceuticals, Fuzhou Suncon Pharmaceutical, Zydus Cadila, Wockhardt, and MANNARIN BIOSCIENCE.
• Regulatory compliance with agencies such as EMA, FDA, and WHO prequalification significantly enhances supplier credibility.
• Regional manufacturers primarily serve local markets but are expanding globally through quality certifications and capacity building.
• Supply chain disruptions are common; diversification of suppliers and continuous monitoring are vital for ensuring consistent access.
• Procurement should prioritize suppliers with robust quality assurance, regulatory approvals, and reliable distribution networks to mitigate risks inherent in critical care pharmaceuticals.

Conclusion

Securing a dependable supply of terlipressin acetate necessitates a strategic approach grounded in regulatory due diligence, supplier reliability, and market dynamics. While established pharmaceutical giants lead the global market, regional manufacturers continue to fill vital gaps, especially in emerging markets. Healthcare organizations must evaluate their sourcing strategies continuously, emphasizing quality assurance, regulatory compliance, and supply resilience to ensure optimal patient outcomes.

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FAQs

1. What criteria should be considered when selecting a supplier for terlipressin acetate?
Suppliers should possess necessary regulatory approvals (e.g., FDA, EMA), GMP compliance, a proven track record of supply reliability, quality certification, and capacity to meet demand fluctuations.

2. Are biosimilar versions of terlipressin acetate available on the market?
Currently, biosimilar versions are limited due to the complex synthesis process and strict regulatory requirements. Most available forms are generic products manufactured by established pharmaceutical companies.

3. How does regional production impact drug quality and availability?
Regional manufacturers may offer cost advantages and quicker access within local markets but might face challenges in meeting international regulatory standards. Verified compliance with quality standards ensures safety and efficacy.

4. What are the key regulatory considerations in importing terlipressin acetate?
Importing entities must verify that the product has approval from the relevant authorities in the destination country, possesses proper documentation (Certificates of Analysis, GMP certification), and complies with local pharmacopoeial standards.

5. How is the global shortage of terlipressin acetate being addressed?
Manufacturers are increasing production capacity, and regulatory agencies encourage the registration of biosimilars and generics. Diversifying supply sources and augmenting local manufacturing capabilities are ongoing strategies to mitigate shortages.

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Sources

1. [1] European Medicines Agency. Terlipressin Summary of Product Characteristics.
2. [2] World Health Organization. Prequalification of Medicines Programme.
3. [3] Ferring Pharmaceuticals. Corporate Overview & Product Portfolio.
4. [4] Indian Pharmaceutical Industry Reports. Market Analysis and Regulatory Frameworks.
5. [5] Industry Market Reports. Global Vasopressin Analogues Market Overview.