Suppliers and packagers for HYCODAN

HYCODAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genus	HYCODAN	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	005213	NDA AUTHORIZED GENERIC	PAI Holdings, LLC dba PAI Pharma	0121-1036-40	4 TRAY in 1 CASE (0121-1036-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05)	2024-08-05
Genus	HYCODAN	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	005213	NDA	Genus Lifesciences Inc.	64950-205-03	30 TABLET in 1 BOTTLE, PLASTIC (64950-205-03)	2021-11-01
Genus	HYCODAN	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	005213	NDA	Genus Lifesciences Inc.	64950-205-10	100 TABLET in 1 BOTTLE, PLASTIC (64950-205-10)	2021-11-01

Last updated: July 27, 2025

ppliers for the Pharmaceutical Drug: HYCODAN

Introduction

HYCODAN, a pharmaceutical formulation containing hydrocodone, is primarily prescribed for pain management and cough suppression. Its formulation typically blends hydrocodone with other agents such as acetaminophen or homatropine. Due to its potent opioid properties, HYCODAN is classified under controlled substances within many jurisdictions, including the United States and Europe. The manufacturing, distribution, and supply chain for HYCODAN involve several specialized pharmaceutical companies, approved distributors, and licensed suppliers adhering to stringent regulatory standards. This analysis provides an overview of the key suppliers involved in HYCODAN's production and distribution landscape.

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Manufacturers of HYCODAN

1. Leading Pharmaceutical Companies
Major pharmaceutical manufacturers globally hold formulations of HYCODAN or its generic equivalents. Companies with established opioid portfolio backgrounds are primary players in this segment.

• Sun Pharmaceutical Industries Ltd.
  As one of the largest generic pharmaceutical companies globally, Sun Pharma produces hydrocodone combinations, complying with regulatory standards such as the US DEA Schedule II classification and corresponding European directives. Their manufacturing plants in India and the US often serve as the source for licensed products distributed internationally.

• Mylan NV (now part of Viatris)
  Mylan historically supplied several hydrocodone-containing formulations, including variants similar to HYCODAN. As one of the leading generic drug manufacturers, they operate manufacturing facilities in the US, India, and Europe. Their extensive API (Active Pharmaceutical Ingredient) and finished product production capacity make them a key supplier in the opioid market.

• Amneal Pharmaceuticals
  Amneal manufactures generic opioids, including hydrocodone combinations, authorized for distribution across North America and other markets. Their manufacturing facilities in the US ensure high compliance with FDA standards.

• Lupin Limited
  With a broad portfolio encompassing opioids, Lupin produces certain hydrocodone-based formulations under licensing agreements with brand owners or through their generic pipeline, serving markets in India, the US, and Asia Pacific.

2. Contract Manufacturing Organizations (CMOs)
Certain pharmaceutical firms outsource production through CMOs to enhance capacity and maintain compliance. Key CMOs involved include:

• Hetero Labs
  Based in India, Hetero supplies API and finished formulations of opioids, including hydrocodone, to authorized distributors and pharmaceutical companies globally.

• Granules India
  As an important CMO in India, Granules produces hydrocodone formulations for various brand and generic companies, adhering to strict quality and regulatory standards.

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Regulatory Authorized Distributors and Suppliers

1. Licensed Distributors in North America
Distribution of HYCODAN is heavily regulated due to its controlled status. The following entities are predominately approved distributors within the United States:

• McKesson Corporation
  A major distributor of controlled substances, McKesson supplies authorized pharmacies and healthcare facilities with HYCODAN, adhering strictly to DEA regulations.

• AmerisourceBergen
  Through their extensive distribution network, AmerisourceBergen supplies licensed HYCODAN formulations to hospitals, pharmacies, and clinics across North America.

• Cardinal Health
  As a key player in pharmaceutical distribution, Cardinal Health manages the supply chain for controlled substances, ensuring compliance with federal and state regulations.

2. European and International Distributors
In Europe, authorized distributors operate under national licensing authorities, with companies such as:

• Phoenix Pharmacy Logistics (UK)
  Supplies controlled drugs, including hydrocodone formulations, to licensed pharmacies and hospitals in the UK and Europe, following MHRA regulations.

• PHOENIX Group (Germany)
  Acts as a major distributor for controlled drugs in the European Union.

3. Online and International Suppliers
While legal purchasing of prescription opioids like HYCODAN requires proper licensing, some international suppliers operate within legal frameworks to supply bulk quantities to licensed distributors. These include licensed API suppliers and certified wholesalers in regions with strict drug control policies.

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Supply Chain Challenges and Considerations

Regulatory Compliance
Due to its classification as a Schedule II substance in the US and similar classifications in other jurisdictions, all suppliers and distributors must comply with the Drug Enforcement Administration (DEA) regulations, Good Manufacturing Practices (GMP), and local licensing requirements.

Supply Chain Security
Counterfeit concerns and diversion risks necessitate stringent security measures across the supply chain. Licensed wholesalers employ serialization, tamper-evident packaging, and real-time inventory monitoring to prevent misuse.

Manufacturing Capacity and Restrictions
Manufacturers face periodic restrictions due to regulatory crackdowns or supply shortages. As opioids are high-control substances, any production or distribution modifications require regulatory approval.

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Conclusion

The supply of HYCODAN hinges on a tightly regulated and complex network involving prominent pharmaceutical manufacturers, CMOs, and authorized distributors. Leading global pharma companies such as Sun Pharma, Viatris (Mylan), Amneal, and Lupin play significant roles in producing generic formulations, often through licensed API suppliers and CMOs. Distribution is primarily managed by licensed entities like McKesson, AmerisourceBergen, and Cardinal Health in the US, with European counterparts adhering to respective regulatory bodies. Ensuring compliance, security, and quality across all stages remains paramount to sustain the supply chain of this potent opioid medication.

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Key Takeaways

• Major generics producers, including Sun Pharma, Viatris (Mylan), Amneal, and Lupin, manufacture HYCODAN or equivalent formulations, often via licensed APIs and CMOs.
• Distribution channels are predominantly controlled and licensed, with McKesson, AmerisourceBergen, and Cardinal Health serving as primary US distributors.
• Strict regulatory adherence, security measures, and capacity management are critical for the legal and safe supply of HYCODAN due to its classification as a Schedule II controlled substance.
• Internationally, licensed distributors such as Phoenix Pharmacy Logistics in the UK and other EU-based entities handle the distribution within regulatory frameworks.
• The supply chain's complexity underscores the importance of compliance, security, and transparency, especially given the public health concerns surrounding opioids.

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FAQs

1. Are there generic equivalents of HYCODAN available globally?
Yes, several pharmaceutical companies produce hydrocodone-based formulations similar to HYCODAN, especially in the US and India, involving licensed generic equivalents.

2. How do companies ensure the security of HYCODAN supply chains?
Through serialization, tamper-evident packaging, real-time tracking, and strict licensing requirements, companies minimize diversion and misuse risks.

3. What regulatory bodies oversee the manufacturing and distribution of HYCODAN?
In the US, the DEA oversees controlled substances, while the FDA regulates manufacturing standards. European companies adhere to EMA and national agencies like MHRA in the UK.

4. Can online pharmacies legally supply HYCODAN?
Only licensed pharmacies with appropriate prescriptions and registration can dispense HYCODAN. Unauthorized online suppliers pose significant legal and health risks.

5. Are there efforts to reduce opioid dependency related to drugs like HYCODAN?
Yes, regulatory agencies, healthcare providers, and manufacturers actively promote responsible prescribing, alternative pain management methods, and monitoring programs to mitigate dependency risks.

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References

[1] U.S. Drug Enforcement Administration. "Controlled Substances Act." DEA.gov.
[2] European Medicines Agency. "Guidelines on the Manufacture of Medicinal Products." EMA.europa.eu.
[3] Fortune Business Insights. "Global Opioids Market Forecast & Trends." FortuneInsights.com.
[4] Mylan NV Annual Reports & Licensing Agreements. Mylan.com.
[5] FDA Drug Approval and Compliance Records. FDA.gov.