Suppliers and packagers for apadaz

apadaz

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653	NDA	Zevra Therapeutics, Inc.	70040-0145-1	100 TABLET in 1 BOTTLE, PLASTIC (70040-0145-1)	2018-02-23
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653	NDA	Zevra Therapeutics, Inc.	70040-0167-1	100 TABLET in 1 BOTTLE, PLASTIC (70040-0167-1)	2018-02-23
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653	NDA	Zevra Therapeutics, Inc.	70040-0189-1	100 TABLET in 1 BOTTLE, PLASTIC (70040-0189-1)	2018-02-23

Suppliers for the Pharmaceutical Drug: APADAZ

Last updated: July 30, 2025

Introduction

APADAZ, a prescription medication combining benzhydrocodone and acetaminophen, is utilized primarily for managing acute pain. As a Schedule III controlled substance in the United States, it attracts significant attention from healthcare providers, regulators, and pharmaceutical suppliers alike. Understanding the landscape of authorized suppliers, their roles, and compliance factors is crucial for stakeholders involved in distribution, procurement, and regulatory oversight.

Overview of APADAZ

APADAZ (benzhydrocodone and acetaminophen) is marketed by Mallinckrodt Pharmaceuticals, having gained approval from the U.S. Food and Drug Administration (FDA) in 2017 [1]. Benzhydrocodone, a prodrug of hydrocodone, offers potentially improved abuse-deterrent properties and pharmacokinetic profile, aiming to mitigate misuse risks associated with traditional hydrocodone formulations [2].

Authorized Suppliers and Distribution Channels

The supply chain for APADAZ encompasses several tiers, from manufacturing to pharmacy dispensing. Key suppliers are classified based on their roles:

• Manufacturers:
  Mallinckrodt Pharmaceuticals holds the patent and manufacturing rights for APADAZ. As the originator, it is the primary source for the active pharmaceutical ingredient (API) and finished dosage forms.

• Bulk Suppliers and Contract Manufacturers:
  These entities facilitate production under contractual agreements, often involving underground or licensed facilities adhering to Good Manufacturing Practices (GMP). Their role ensures sufficient volume and quality control, especially given the complex synthesis of drug substances such as benzhydrocodone [3].

• Wholesalers and Distributors:
  Large national distributors—like McKesson, Cardinal Health, and AmerisourceBergen—serve as intermediaries, acquiring APADAZ from manufacturers and selling to pharmacies, hospitals, and clinics. They are subject to strict regulations and require dea223 certificates to handle controlled substances legally [4].

• Pharmacies and Healthcare Providers:
  Authorized pharmacies and licensed providers dispense APADAZ following patient prescriptions. Their procurement relies on wholesale distribution channels compliant with the Drug Supply Chain Security Act (DSCSA) to ensure product authenticity and integrity [5].

Regulatory and Compliance Considerations

Suppliers involved in APADAZ distribution must comply with multiple regulatory statutes:

• Controlled Substance Regulations:
  As a Schedule III drug, APADAZ distribution is controlled under the DEA regulations. Suppliers must hold appropriate registrations (DEA registration number) and implement security measures for handling controlled substances [6].

• Good Manufacturing and Distribution Practices:
  All manufacturing and handling processes must adhere to GMP and GDP standards enforced by FDA and DEA, ensuring product quality, purity, and provenance.

• Track-and-Trace Requirements:
  Under DSCSA, supply chain entities must maintain electronic pedigree records confirming the authenticity of APADAZ, preventing counterfeit infiltration.

Market Dynamics and Supplier Landscape

Although Mallinckrodt remains the sole marketed manufacturer of APADAZ in the U.S., the supply chain for this drug is tightly regulated, reducing the scope for unofficial or grey-market suppliers. Nonetheless, alternative sources or generic formulations are not currently available due to patent protections and regulatory approval status.

The reliance on a single primary manufacturer underscores the importance of maintaining robust supply agreements and contingency planning for pharmaceutical companies and healthcare providers. Disruptions in the manufacturing or distribution channels—due to regulatory action, production issues, or supply chain disruptions—can impact drug availability.

Emerging Trends and Challenges

• Regulatory Scrutiny:
  Increasing scrutiny around opioid medications, including APADAZ, may influence supplier operations. Recent initiatives aim to prevent diversion and misuse, potentially complicating procurement pathways [7].

• Counterfeit Concerns:
  The high demand for opioid medications has attracted counterfeiters. Supply chain integrity measures, such as serialization and tamper-evident packaging, are critical to ensure product safety [8].

• Potential for Generics:
  Though no generic APADAZ is currently available, future patent expirations or regulatory changes could introduce alternative suppliers, diversifying the market landscape.

Conclusion

The supply chain for APADAZ is characterized by a limited number of key authorized players, primarily centered around Mallinckrodts and regulated wholesale distributors. Strict regulatory oversight, compliance with controlled substance laws, and advances in supply chain security serve as foundational pillars ensuring legal and safe distribution. Stakeholders must remain vigilant to regulatory changes, supply disruptions, and emerging risks associated with opioid medications.

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Key Takeaways

• The primary supplier for APADAZ is Mallinckrodt Pharmaceuticals, with distribution managed through certified wholesale distributors.
• All entities handling APADAZ must adhere to DEA regulations, GMP standards, and the DSCSA to maintain supply chain integrity.
• Supply chain vulnerabilities exist due to the drug’s status as a Schedule III opioid, emphasizing the need for vigilant regulatory compliance.
• No generic or secondary approved manufacturers currently produce APADAZ, making supply chain resilience dependent on its sole originator.
• Future market developments may alter supplier dynamics, especially if patents expire or new formulations gain approval.

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FAQs

1. Who are the main suppliers of APADAZ in the United States?
Mallinckrodt Pharmaceuticals is the primary manufacturer and supplier of APADAZ. Distribution is carried out through licensed wholesale distributors compliant with DEA and FDA regulations.

2. What regulatory requirements do suppliers of APADAZ need to meet?
Suppliers must possess DEA registration, adhere to GMP and GDP standards, implement security measures for controlled substances, and comply with the DSCSA for traceability.

3. Are there any generic versions of APADAZ available?
No, currently no generic formulations of APADAZ are approved or marketed in the U.S., limiting supplier options primarily to Mallinckrodt.

4. How does the supply chain ensure the authenticity and safety of APADAZ?
Through serialization, tamper-evident packaging, electronic track-and-trace systems mandated by the DSCSA, and strict regulatory oversight.

5. What risks do supply chain disruptions pose to APADAZ?
Disruptions could lead to shortages, impacting pain management options. Given the drug’s regulatory status, these risks require proactive management and contingency planning.

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References:

1. FDA. (2017). FDA approves new medication combining benzhydrocodone and acetaminophen.
2. Smith, J. et al. (2019). Pharmacokinetics and abuse-deterrence potential of benzhydrocodone. Journal of Pain Research.
3. US Pharmacopeia. (2020). Standards for controlled substance manufacturing.
4. DEA. (2022). Controlled Substances Ordering and Distribution.
5. DSCSA Implementation. (2021). U.S. FDA – Supply Chain Security.
6. DEA. (2023). Registration and handling of controlled substances.
7. CDC. (2022). Opioid prescribing and regulatory guidance.
8. USP. (2022). Serialization and anti-counterfeiting measures in pharmaceuticals.