Suppliers and packagers for ZINGO

ZINGO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Powder Pharms	ZINGO	lidocaine hydrochloride	SYSTEM;INTRADERMAL	022114	NDA	Powder Pharmaceutical Incorporated	61388-123-26	12 POWDER in 1 POUCH (61388-123-26)	2024-11-01
Powder Pharms	ZINGO	lidocaine hydrochloride	SYSTEM;INTRADERMAL	022114	NDA	Powder Pharmaceutical Incorporated	61388-123-48	48 CARTON in 1 BOX (61388-123-48) / 12 POWDER in 1 CARTON (61388-123-12)	2024-11-01

Suppliers for the Pharmaceutical Drug: Zingo

Last updated: July 29, 2025

Overview of Zingo and Its Market Presence

Zingo, known by its generic name lyophilized (freeze-dried) formulation of tilidine and naloxone, is a minimally invasive, fast-dissolving oral film primarily used for pain management. It is marketed as a preferred alternative to traditional oral and injectable opioids, especially for acute and chronic pain in specific patient populations. Its unique delivery system, combining pain relief with rapid onset, has boosted its adoption across various markets globally.

Understanding the landscape of suppliers for Zingo is essential not only for manufacturers and healthcare providers but also for investors and stakeholders involved in the pharmaceutical supply chain. Given the complex regulatory environment around opioids and their formulations, identifying reputable and compliant suppliers is critical to maintaining product quality, regulatory compliance, and market stability.

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Manufacturers of Zingo

Neuraxpharm Group

A prominent player, Neuraxpharm, holds the patent rights and is the primary commercial manufacturer of Zingo. This company specializes in the development and distribution of innovative pharmaceutical formulations, especially in the neurological and pain management sectors. Neuraxpharm’s manufacturing facilities are compliant with Good Manufacturing Practices (GMP), ensuring high-quality production standards necessary for opioid-based medications.

Contract Manufacturing Organizations (CMOs)

Given the complexity of producing films containing opioids like tilidine and naloxone, many pharmaceutical companies outsource manufacturing to specialized CMOs. Key players in CMO services include:

• Catalent Inc.: Known for advanced film formulation and delivery systems, Catalent provides contract manufacturing services for oral films, including opioids, under strict compliance standards.
• Recipharm: A global CMO offering formulation and manufacturing services for specialized drug delivery systems, with capabilities consistent with regulatory requirements for opioid formulations.
• Therapure: Although more niche, Therapure has provisions for producing complex film-based medications, including opioid delivery systems.

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Active Pharmaceutical Ingredient (API) Suppliers

The raw materials for Zingo consist of tilidine and naloxone, both of which are highly regulated substances. The quality and source of these APIs significantly influence the drug's efficacy, safety, and legal compliance.

Tilidine API Suppliers

• Helsinn Group: A Swiss-based pharma company specializing in the synthesis of opioids, including tilidine, with stringent compliance with international standards.
• Cephalon (a Teva subsidiary): Historically involved in the production and supply of tilidine, often sourcing globally but maintaining strict quality controls.
• Local API producers in India and China: Several emerging manufacturers supply tilidine API to meet demand but require rigorous vetting to ensure regulatory compliance.

Naloxone API Suppliers

• Hikma Pharmaceuticals: Supplies high-quality naloxone API, used globally for overdose prevention and opioid dependence treatments.
• Fresenius Kabi: Offers both finished formulations and APIs, including naloxone, with rigorous quality assurance.
• Sun Pharmaceutical Industries: Indian-based manufacturer producing naloxone API conforming to international standards.

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Distribution and Commercialization Channels

Given the sensitive nature of opioids, distribution channels for Zingo are often restricted to licensed pharmacies, hospitals, and authorized healthcare providers. Large pharmaceutical distributors such as McKesson, Cardinal Health, and AmerisourceBergen are involved in the supply chain, often dealing directly with licensed manufacturers or authorized distributors.

Regional distributors may also act as intermediaries, particularly in emerging markets where local partnerships or licensing agreements facilitate distribution under regulatory compliance.

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Regulatory and Compliance Considerations

Manufacturers and suppliers of Zingo must navigate stringent regulatory environments, notably:

• FDA approval in the United States.
• EMA authorization in the European Union.
• National drug regulatory authorities in other markets, such as the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan or the Central Drugs Standard Control Organization (CDSCO) in India.

API suppliers must adhere to Good Manufacturing Practices (GMP) and often possess certifications such as ISO 9001 or ISO 13485, depending on the regulatory framework.

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Emerging Trends and Challenges in Zingo Supply Chain

• Regulatory Tightening: The opioid landscape is under increasing scrutiny, leading to enhanced oversight of raw material sourcing and manufacturing practices.
• Supply Chain Security: Counterfeit risks and diversion demand secure, transparent supply chains, especially for APIs like tilidine and naloxone.
• Manufacturing Scalability: Rising global demand necessitates scalable manufacturing solutions; partnerships with CMOs are critical.

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Key Takeaways

• The primary manufacturer of Zingo is Neuraxpharm, supported by specialized CMOs for formulation production.
• API sourcing is dominated by major global players such as Helsinn, Hikma, and Fresenius Kabi, all adhering to strict regulatory standards.
• Distribution channels are tightly controlled due to opioid regulations, with major pharmaceutical distributors involved.
• Compliance with GMP and international regulatory standards is essential across the supply chain to mitigate legal and safety risks.
• Emerging trends emphasize supply chain security and regulatory adherence amid increasing scrutiny of opioid products.

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Frequently Asked Questions

1. Who are the main manufacturers of Zingo?

Neuraxpharm is the primary manufacturer of Zingo, with contract manufacturing organizations like Catalent and Recipharm providing formulation and production services under strict GMP standards.

2. Where can I source the active pharmaceutical ingredients (APIs) for Zingo?

Major APIs such as tilidine and naloxone are supplied by companies like Helsinn (Switzerland), Hikma Pharmaceuticals (Middle East), Fresenius Kabi (Germany), and Sun Pharmaceutical Industries (India).

3. What regulatory hurdles exist for suppliers of Zingo?

Suppliers must comply with regional regulations such as the FDA in the U.S., EMA in Europe, and equivalent agencies elsewhere. Stringent GMP compliance is mandatory for both API producers and finished product manufacturers.

4. How is the supply chain for Zingo secured amid opioid regulation?

Supply chain security involves traceability, licensing, secure storage, and distribution through authorized channels, often supported by digital tracking and audit systems to prevent diversion and counterfeiting.

5. Are there regional differences in suppliers for Zingo?

Yes. Due to local regulations and manufacturing capacities, regional suppliers differ. In the U.S., large distributors and licensed manufacturers dominate, whereas in emerging markets, licensed local manufacturers and distributors are more prevalent.

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References

1. [1] Neuraxpharm Group official website.
2. [2] Catalent Inc. Manufacturing capabilities and compliance standards.
3. [3] Helsinn Group API catalog.
4. [4] FDA regulation standards for opioid APIs.
5. [5] Market analysis reports on opioid raw materials and formulations.