Suppliers and packagers for demerol

demerol

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	DEMEROL	meperidine hydrochloride	INJECTABLE;INJECTION	021171	NDA	Hospira, Inc.	0409-1176-30	10 CARTRIDGE in 1 CARTON (0409-1176-30) / 1 mL in 1 CARTRIDGE (0409-1176-03)	2005-08-25
Hospira	DEMEROL	meperidine hydrochloride	INJECTABLE;INJECTION	021171	NDA	Hospira, Inc.	0409-1178-30	10 CARTRIDGE in 1 CARTON (0409-1178-30) / 1 mL in 1 CARTRIDGE (0409-1178-03)	2005-09-13
Hospira	DEMEROL	meperidine hydrochloride	INJECTABLE;INJECTION	021171	NDA	Hospira, Inc.	0409-1179-30	10 CARTRIDGE in 1 CARTON (0409-1179-30) / 1 mL in 1 CARTRIDGE (0409-1179-03)	2005-10-12
Hospira	DEMEROL	meperidine hydrochloride	INJECTABLE;INJECTION	021171	NDA	Hospira, Inc.	0409-1181-30	1 VIAL, MULTI-DOSE in 1 CARTON (0409-1181-30) / 30 mL in 1 VIAL, MULTI-DOSE	2006-02-24
Quagen	DEMEROL	meperidine hydrochloride	INJECTABLE;INJECTION	005010	NDA	Validus Pharmaceuticals LLC	30698-335-01	100 TABLET in 1 BOTTLE, PLASTIC (30698-335-01)	1942-11-10
Quagen	DEMEROL	meperidine hydrochloride	INJECTABLE;INJECTION	005010	NDA	Validus Pharmaceuticals LLC	30698-337-01	100 TABLET in 1 BOTTLE, PLASTIC (30698-337-01)	1942-11-10

Suppliers for the Pharmaceutical Drug: Demerol

Introduction
Demerol, the brand name for meperidine hydrochloride, is a potent synthetic opioid analgesic historically used for moderate to severe pain management. Its clinical application has declined due to safety concerns, but it remains available in certain markets and formulations. Identifying reliable suppliers of Demerol is critical for pharmaceutical manufacturers, healthcare providers, and regulatory authorities. This comprehensive analysis explores the landscape of Demerol suppliers, highlighting manufacturing sources, geopolitical influences, manufacturing quality standards, and the global supply chain dynamics shaping its distribution.

1. Overview of Demerol and Its Market
Demerol (meperidine hydrochloride) first gained approval in the 1930s and became a staple in analgesic therapy by the mid-20th century. Though it has been largely replaced by other opioids like fentanyl, oxycodone, and hydromorphone, Demerol persists in certain regional markets and specific medical contexts. The drug’s manufacturing is regulated under stringent pharmaceutical standards, with suppliers typically operating within countries with advanced regulatory oversight, such as the United States, European Union member states, India, and China.

2. Major Manufacturers of Demerol
The supply of Demerol is primarily controlled by a limited set of pharmaceutical companies, many of which are integrated vertical producers of opioid analgesics. Key players include:

• Sanofi: Historically, Sanofi Aventis was one of the primary manufacturers of meperidine in the United States. Although Sanofi officially exited the opioids market, its legacy manufacturing facilities may still produce Demerol under licensing agreements or residual supplies (1).

• Mallinckrodt Pharmaceuticals: A prominent supplier of opioids, Mallinckrodt has historically supplied meperidine to various markets and maintains production capabilities compliant with regulatory standards. The company continues to supply opioid medications under rigorous controls (2).

• Synthesis and API Suppliers in India and China
  Indian pharmaceutical companies such as Sun Pharmaceutical Industries and IPCA Laboratories, along with Chinese manufacturers like Jiangsu Hengrui Medicine Co., Ltd., manufacture active pharmaceutical ingredients (APIs) including meperidine for export and domestic use. These producers often operate under WHO Good Manufacturing Practices (GMP) and adhere to international standards, serving global demands.

• Contract Manufacturing Organizations (CMOs): Several CMOs globally offer custom synthesis and manufacturing services for meperidine API, enabling pharmaceutical companies to outsource supply amidst capacity constraints or regulatory considerations (3).

3. Source Countries and Regulatory Considerations
The manufacturing and distribution of Demerol involve complex regulatory frameworks due to its classification as a Schedule II controlled substance in the United States and similarly restrictive statuses elsewhere. Suppliers must navigate domain-specific regulations, including:

• United States: The Drug Enforcement Administration (DEA) tightly controls opioid manufacturing, requiring registration, licensing, and adherence to strict import/export protocols (4).

• European Union: Under European Medicines Agency (EMA) regulations, suppliers must ensure GMP compliance and adhere to cannabis and opioid control laws.

• India and China: These countries serve as major API manufacturing hubs, with stricter domestic controls evolving to meet international standards. Export approvals are often necessary for cross-border trade.

4. Supply Chain Challenges and Risks
The Demerol supply chain encounters several vulnerabilities:

• Regulatory Restrictions: Stringent controls limit the number of approved suppliers, creating dependency risks.

• Manufacturing Capacity Limitations: As use declines, some manufacturers have scaled down production, impacting global supply availability.

• Counterfeit and Illicit Markets: The black market for opioids is active, with counterfeit Demerol posing safety risks. Ensuring supplier authenticity is critical.

• Geopolitical Factors: Tariffs, trade restrictions, and sanctions can disrupt sourcing from certain countries, notably during geopolitical tensions.

5. Emerging Trends and Future Outlook
The opioid crisis has prompted healthcare systems worldwide to impose tighter controls, reducing the proliferation of Demerol suppliers. However, demand persists in specific regions, leading to continued reliance on established API producers. Future trends include:

• Increased Use of Contract Manufacturing: To maintain supply without overextending manufacturing capacity.

• Regulatory Harmonization: International efforts aim to standardize controls, reducing clandestine market activity.

• Development of Safer Alternatives: As the safety profile of Demerol declines, interest grows in synthetic alternatives or non-opioid analgesics, likely reducing demand and influencing supply chains.

6. Conclusion
The supplier landscape for Demerol is concentrated among a handful of pharmaceutical giants and API manufacturers primarily located in North America, Europe, India, and China. The highly regulated nature of opioid manufacturing poses barriers to entry and sustains tight control over availability. While legacy manufacturers have maintained supply, ongoing decline in demand and safety concerns are expected to influence future sourcing patterns. Stakeholders must prioritize due diligence, regulatory compliance, and risk mitigation when engaging with Demerol suppliers.

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Key Takeaways

• The global Demerol supply chain is dominated by established pharmaceutical companies and API manufacturers in North America, Europe, India, and China.
• Regulatory oversight and control restrictions significantly influence supplier availability and market dynamics.
• Manufacturing capacity constraints and geopolitical risks can disrupt supply, emphasizing the importance of diversified sourcing strategies.
• The decline in Demerol’s clinical use due to safety concerns is likely to further diminish its supplier base over time.
• Ensuring supplier authenticity and compliance is critical given the drug’s regulated status and the black market activity surrounding opioids.

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FAQs

Last updated: July 30, 2025

1. Who are the primary global suppliers of Demerol?
Primarily, established pharmaceutical companies such as Mallinckrodt and legacy producers like Sanofi have historically supplied Demerol. Additionally, API manufacturers in India (e.g., Sun Pharmaceutical, IPCA Labs) and China (e.g., Jiangsu Hengrui) produce meperidine for global distribution, often through contract manufacturing.

2. What regulatory factors influence Demerol suppliers?
As a Schedule II controlled substance, Demerol manufacturing and distribution are governed by strict regulations in countries like the US (DEA oversight), the EU (EMA compliance), and others. These regulations regulate licensing, manufacturing standards, import/export permissions, and distribution channels.

3. Are there risks associated with sourcing Demerol from emerging markets?
Yes. While India and China are major API hubs, challenges include varying quality standards, regulatory differences, potential counterfeit products, and geopolitical issues impacting trade and supply continuity.

4. Has Demerol production declined recently?
Yes. Growing safety concerns and declining clinical use have led many manufacturers to reduce or cease Demerol production, leading to a shrinking supplier base for this opioid.

5. What are the prospects for future Demerol supply?
Future supply is expected to diminish further unless demand persists in specific regions or for niche medical uses. Suppliers may focus on maintaining existing inventories or transitioning to alternative analgesics with improved safety profiles.

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References

1. Sanofi Official Website. "History and product portfolio." Accessed 2023.
2. Mallinckrodt Pharmaceuticals. "Opioid Medication Portfolio." 2022.
3. Global Pharma Contract Manufacturing Reports. "API Market Trends." 2022.
4. DEA Office of Diversion Control. "Controlled Substances Act Regulations." 2023.