Last updated: July 30, 2025
Introduction
DILAUDID-HP, an extended-release formulation of hydromorphone hydrochloride, is a potent opioid analgesic used in the management of severe pain. Due to its high potential for abuse and regulatory restrictions, the supply chain for DILAUDID-HP is highly controlled with a limited number of authorized manufacturers and suppliers. This report provides a comprehensive analysis of the key suppliers for DILAUDID-HP, examining manufacturer profiles, distribution channels, regulatory considerations, and strategic implications for stakeholders.
Overview of DILAUDID-HP Production and Regulation
As a Schedule II controlled substance under the Controlled Substances Act (CSA), DILAUDID-HP manufacturing and distribution are tightly regulated by authorities such as the U.S. Drug Enforcement Administration (DEA). Manufacturers must adhere to stringent Good Manufacturing Practices (GMP), track inventory meticulously, and comply with serialization and reporting mandates to prevent diversion and illicit use.
The production of DILAUDID-HP involves complex formulation processes designed to deliver sustained analgesic effects while minimizing abuse potential. These complexities limit the number of licensed manufacturers capable of producing this specialized pharmaceutical.
Major Manufacturers and Suppliers of DILAUDID-HP
1. Purdue Pharma L.P.
Profile:
Purdue Pharma, historically the primary manufacturer of DILAUDID (hydromorphone hydrochloride), also produces the extended-release DILAUDID-HP formulation. As a privately held company, Purdue has played a dominant role in the opioid market in the United States, including the supply of DILAUDID-HP.
Manufacturing Capabilities:
Purdue leverages advanced GMP-compliant facilities with extensive experience in opioid formulations. Their production processes are tailored to sustain the controlled-release matrix necessary for DILAUDID-HP.
Distribution Channels:
DILAUDID-HP is distributed primarily through licensed specialty pharmacies, wholesaler networks, and direct agreements with healthcare providers and hospitals. The company maintains strict controls to ensure compliance with DEA regulations.
Regulatory Status:
Purdue has faced significant legal and regulatory scrutiny, prompting efforts to improve transparency and compliance. Despite these challenges, Purdue remains a leading supplier of DILAUDID-HP.
2. Hikma Pharmaceuticals
Profile:
Hikma Pharmaceuticals, a global pharmaceutical company headquartered in Jordan, is among the key international suppliers of generic opioids, including hydromorphone extended-release formulations similar to DILAUDID-HP.
Manufacturing Capabilities:
Hikma operates multiple GMP-certified facilities capable of producing controlled substances with high quality standards. They manufacture both branded and generic opioids for global markets.
Distribution Channels:
Hikma’s supply chain for controlled substances is highly regulated and involves direct engagement with authorized distributors and government agencies across multiple countries, including the U.S.
Regulatory Status:
Hikma closely collaborates with regulatory authorities like the DEA in the U.S. and the MHRA in the UK, ensuring their products meet necessary compliance standards.
3. Sun Pharmaceutical Industries Ltd.
Profile:
Sun Pharma is a notable player in the global generic pharmaceutical industry, with licensed manufacturing of hydromorphone formulations, including extended-release versions.
Manufacturing Capabilities:
Sun Pharma’s facilities are GMP-certified, with a focus on producing controlled substances under tight regulatory oversight.
Distribution Channels:
The company supplies controlled-release opioids primarily to North America, Europe, and Asia via authorized wholesalers and direct pharmaceutical channels.
Regulatory Status:
Sun Pharma’s controlled substances manufacturing processes adhere to DEA regulations, with ongoing compliance audits underpinning their licensing.
Secondary and Emerging Suppliers
While the primary licensed manufacturers dominate the supply landscape, some emerging or secondary suppliers operate under limited licenses or in specific international markets:
- Medi-Pharma Inc. (Canada): Operates under Canadian regulatory standards, supplying hydromorphone formulations, including controlled-release variants.
- Lupin Limited (India): Engages in the manufacture of generic opioids, including extended-release hydromorphone products, under strict regulatory compliance for export.
Supply Chain and Distribution Considerations
1. Regulatory Compliance:
Suppliers must maintain DEA Schedule II registration and comply with serialization, reporting, and strict inventory tracking to prevent diversion.
2. Distribution Channels:
Distribution is predominantly channeled through licensed narcotics distributors and specialty pharmacies, which have mechanisms in place for secure handling and monitoring.
3. Procurement Challenges:
Supply chain disruptions, regulatory restrictions, and manufacturing capacity limitations influence availability. The opioid crisis has led to increased scrutiny, potentially limiting new market entrants.
Strategic Implications for Stakeholders
- Healthcare Providers: Should establish direct relationships with approved suppliers to ensure reliable procurement.
- Distributors: Must uphold compliance standards and implement robust tracking systems.
- Regulatory Bodies: Continuously monitor manufacturing practices and distribution channels to prevent diversion.
- Pharmaceutical Companies: Potential entrants into the market must navigate complex licensing and regulatory landscapes, which serve as barriers to new suppliers.
Conclusion
The supply landscape for DILAUDID-HP is characterized by a small, highly regulated group of pharmaceutical manufacturers with proven expertise in controlled substance production. Purdue Pharma remains the dominant supplier in the United States, with Hikma Pharmaceuticals and Sun Pharma serving as notable international contributors. These organizations operate within strict regulatory frameworks, utilizing secure distribution channels to ensure compliance and supply integrity. Stakeholders must maintain vigilance regarding regulatory and supply chain changes to sustain reliable access to this potent analgesic.
Key Takeaways
- Limited Supplier Pool: Only a handful of licensed manufacturers, predominantly Purdue Pharma, Hikma, and Sun Pharma, provide DILAUDID-HP.
- Regulatory Stringency: Strict DEA regulations and GMP standards significantly influence manufacturing and distribution.
- Supply Chain Security: Controlled distribution channels and serialization are vital to prevent diversion.
- Market Dynamics: Legal scrutiny and market restrictions impact supply stability and new entrants.
- Strategic Focus: Stakeholders should foster relationships with authorized suppliers and stay informed of regulatory developments.
FAQs
1. Who are the primary manufacturers of DILAUDID-HP in the US?
Purdue Pharma remains the leading manufacturer of DILAUDID-HP in the United States, supported by regulated distribution channels. Internationally, Hikma Pharmaceuticals and Sun Pharma are notable suppliers of similar hydromorphone extended-release formulations.
2. How does regulatory oversight impact the supply of DILAUDID-HP?
Strict DEA scheduling and GMP requirements limit manufacturing to licensed entities, enforce serialization and inventory tracking, and regulate distribution channels, ensuring compliance and reducing diversion risks.
3. Can new manufacturers enter the DILAUDID-HP supply chain?
While possible, new entrants face significant hurdles, including obtaining DEA registration, demonstrating GMP compliance, and navigating legal restrictions associated with controlled substances, making market entry challenging.
4. What are the risks of supply disruption for DILAUDID-HP?
Risks include regulatory actions, manufacturing capacity constraints, legal challenges, and supply chain disruptions due to heightened regulation or enforcement actions, potentially impacting availability.
5. Are there international suppliers for DILAUDID-HP?
Yes. Companies like Hikma and Sun Pharma supply hydromorphone formulations globally, subject to country-specific regulations and licensing requirements, with some licensed for exports to markets like Canada, Europe, and Asia.
Sources:
[1] U.S. Drug Enforcement Administration (DEA). Controlled Substances Act.
[2] Purdue Pharma Annual Reports & Regulatory Disclosures.
[3] Hikma Pharmaceuticals Official Website.
[4] Sun Pharma Corporate Governance & Compliance Records.
