symproic: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854	NDA	BioDelivery Sciences International Inc	59385-041-30	30 TABLET in 1 BOTTLE, PLASTIC (59385-041-30)	2019-06-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

SYMPROIC is a prescription medication used in the treatment of certain infections, notably complicated skin and soft tissue infections. As an antimicrobial agent, its supply chain involves a complex network of manufacturers, authorized distributors, and regulatory authorities globally. Understanding the landscape of suppliers for SYMPROIC is vital for stakeholders, including healthcare providers, pharmaceutical distributors, and investors, to ensure medication availability and compliance with regulatory standards.

Overview of SYMPROIC

SYMPROIC is synonymous with Dalbavancin, a lipoglycopeptide antibiotic developed for targeted use against Gram-positive bacteria such as Methicillin-resistant Staphylococcus aureus (MRSA). Its long half-life allows for single-dose or two-dose regimens, providing clinical advantages in outpatient settings, reducing hospitalization times.

Its manufacturing and distribution are subject to rigorous regulatory oversight, particularly by agencies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national bodies. This oversight influences the supply chain's structure and the distribution channels.

Primary Manufacturers of SYMPROIC

1. Melinta Therapeutics

Melinta Therapeutics holds the patent and manufacturing rights for Dalbavancin, marketed commercially as SYMPROIC in the United States. Since its debut, Melinta has been the sole approved manufacturer responsible for the bulk production and distribution within the U.S.

Manufacturing Facilities: Melinta operates approved manufacturing facilities adhering to Current Good Manufacturing Practices (CGMP). These facilities are located primarily in the United States, ensuring regulatory compliance and supply chain security.
Research and Development: The company invests in ongoing R&D to optimize production processes and explore new formulations.

2. International Manufacturers

Outside North America, the rights and manufacturing of Dalbavancin are held by different pharmaceutical companies, with some licensed agreements allowing regional production or distribution.

Global Licensing Partners: Several pharmaceutical firms, especially in Europe and Asia, hold licensing rights, securing local manufacturing standards compliance.
Regional Production: In different jurisdictions, local manufacturers may produce Dalbavancin under licensing agreements with Melinta or other patent holders, conforming to regional regulatory standards.

Authorized Distributors and Supply Chain Channels

United States

Direct Distribution: Melinta Therapeutics maintains direct relationships with hospitals, clinics, and pharmacies through national and regional distribution networks.
Wholesaler Partnerships: Major pharmaceutical wholesalers such as McKesson, Cardinal Health, and AmerisourceBergen serve as intermediaries, ensuring broad access across healthcare facilities.

International Markets

Regional Distributors: In Europe and Asia, licensed distributors handle the distribution. For example, in the EU, licensing agreements with local pharmaceutical companies enable regional manufacturing and distribution.
Export Regulations: Export of SYMPROIC outside the U.S. depends on regional regulatory approval and licensing agreements. Manufacturers and authorized distributors ensure compliance with these regulations.

Regulatory and Compliance Factors

The supply chain for SYMPROIC is heavily influenced by regulatory requirements. Continuous compliance with CGMP, WHO prequalification standards (for international markets), and regional regulatory agencies' approvals is essential to sustain manufacturing and distribution.

U.S. Market: The FDA approves manufacturing facilities, monitors supply chain integrity, and oversees adverse event reporting.
Global Market: EMA approval or equivalent local regulatory consent is required, influencing licensing agreements and supply routes.

Any disruption, such as manufacturing plant closures, regulatory delays, or compliance issues, can significantly impact supply availability.

Supply Chain Challenges and Risk Management

Given the niche nature of Dalbavancin production, several risks could affect the supply chain:

Limited Manufacturer Base: The reliance on a single primary manufacturer in the U.S. amplifies supply vulnerability.
Regulatory Bottlenecks: Delays in approval or compliance issues can interrupt production.
Global Supply Disruptions: Pandemic-related logistics disruptions or geopolitical issues can affect international supply chains.
Patent and Licensing Constraints: Patent expirations or licensing disputes may alter manufacturing rights and availability.

Proactive risk management hinges on maintaining multiple licensed manufacturing sites globally and diversified distribution partnerships.

Emerging Trends and Future of Suppliers

Biosimilar and Generic Development: As patents expire or licensing agreements evolve, additional manufacturers may enter the market, expanding supplier diversity.
Local Manufacturing Initiatives: Governments and private companies are exploring local production to mitigate supply chain vulnerabilities.
Expanding Geographies: Increasing approval in emerging markets opens new licensing and manufacturing opportunities, potentially broadening the supplier base.

Key Takeaways

Primary Manufacturer: Melinta Therapeutics remains the sole manufacturer of SYMPROIC in the U.S., with regional licensing agreements supporting global supply.
Distribution Channels: The drug relies on a network of authorized wholesalers and regional distributors, depending on geographic markets.
Regulatory Compliance: Manufacturing and distribution are heavily regulated; disruptions or non-compliance pose significant supply risks.
Market Dynamics: Patent protections, licensing agreements, and emerging biosimilar developments will shape future supplier availability.
Supply Chain Resilience: Diversification of manufacturing sources and strengthening regional licensing agreements are essential for mitigating supply risks.

FAQs

1. Who manufactures SYMPROIC in the United States?
Melinta Therapeutics is the exclusive manufacturer responsible for SYMPROIC’s production in the U.S.

2. Are there international manufacturers producing SYMPROIC?
Yes, licensing agreements with regional pharmaceutical companies allow for local manufacturing and distribution in Europe, Asia, and other regions.

3. How does the supply chain for SYMPROIC ensure drug availability?
Through authorized distributors, wholesalers, regional licensing, and strict regulatory compliance, the supply chain maintains drug availability.

4. What risks could disrupt SYMPROIC’s supply?
Manufacturing plant issues, regulatory delays, patent disputes, or logistics disruptions could impact supply.

5. Are biosimilars or generics expected for SYMPROIC?
Currently, there are no biosimilars or generics, but patent expirations and licensing changes may lead to new entrants in the future.

Sources

[1] Melinta Therapeutics. (2023). Product Portfolio and Manufacturing Capabilities.
[2] FDA. (2022). Approved Drugs — Summary of Qualifications.
[3] EMA. (2023). European Marketing Authorizations for Antibiotics.
[4] Industry Reports. (2023). Global Distribution and Licensing Agreements for Dalbavancin.

Suppliers and packagers for symproic

symproic

Suppliers for the Pharmaceutical Drug: SYMPROIC