Last updated: July 27, 2025
Introduction
Meperidine hydrochloride, also known as Pethidine, is a synthetic opioid analgesic historically used for the relief of moderate to severe pain and anesthesia premedication. Despite declining usage due to safety concerns and the availability of alternative analgesics, it remains produced by various suppliers globally, especially for research, compounding, or specific medical applications. This report provides an in-depth overview of the prominent suppliers of Meperidine hydrochloride, their market presence, regulatory status, and supply chain considerations crucial for healthcare providers, pharmaceutical companies, and regulatory agencies.
Market Overview and Regulatory Status
The manufacturing, distribution, and purchase of Meperidine hydrochloride are subject to stringent regulations worldwide. The drug is classified as a controlled substance in many jurisdictions due to its opioid nature, with schedules varying by country. In the United States, it is classified as a Schedule II drug under the Controlled Substances Act (CSA), reflecting strict regulations on manufacturing, distribution, and prescriptions. Similar classifications are observed in Europe, Canada, and Australia, which impacts supply chain dynamics and supplier operability.
Despite reduced medical use — largely replaced by other opioids with improved safety profiles — Meperidine remains available through specialized suppliers catering to research institutions, compounding pharmacies, and certain niche markets. Its production is often limited to certified pharmaceutical manufacturers with licenses adhering to Good Manufacturing Practices (GMP).
Key Global Suppliers of Meperidine Hydrochloride
1. Pfizer Inc.
Overview: Pfizer, one of the world's leading pharmaceutical firms, historically produced Meperidine hydrochloride. Pfizer’s broad portfolio encompasses both branded and generic medications, with a track record of producing controlled substances under strict regulatory compliance.
Supply Dynamics: Pfizer's manufacturing facilities operate under stringent GMP conditions, ensuring consistent quality and adherence to regulatory standards. While Pfizer has scaled back some production of older opioids due to safety concerns, its legacy production facilities still maintain supplies for existing demand, especially in research or veterinary uses.
Regulatory Considerations: Pfizer holds the necessary licenses for controlled substance manufacturing, complying with the Drug Enforcement Administration (DEA) regulations in the US and equivalent authorities elsewhere. Distribution is tightly controlled, with compliance documentation required at all supply chain points.
2. Sun Pharmaceutical Industries Ltd.
Overview: Based in India, Sun Pharmaceutical is among the world's largest specialty generic pharmaceutical companies. It manufactures Meperidine hydrochloride as part of its analgesic portfolio, primarily supplying developing markets and research entities.
Supply Dynamics: Sun Pharmaceutical maintains GMP-certified manufacturing plants. Its production capacity and quality management systems enable consistent supply for local and export markets, including countries where regulations permit authorized use of opioids.
Regulatory Considerations: As with other opioids, Sun Pharmaceutical’s production and distribution of Meperidine are heavily regulated. The company reports compliance with national drug control laws, including those of the Central Drugs Standard Control Organization (CDSCO) in India.
3. Chinese Pharmaceutical Manufacturers (e.g., North China Pharmaceutical Group Corp.)
Overview: Several Chinese manufacturers produce Meperidine hydrochloride, often supplying generic markets globally. These manufacturers benefit from high-volume manufacturing capabilities, competitive pricing, and expanding export channels.
Supply Dynamics: These firms often operate under strict GMP standards to meet international specifications, especially as they export to the US, European Union, and other regulated markets. Quality assurance varies; hence, due diligence is advised when sourcing from less-known suppliers.
Regulatory Considerations: Chinese manufacturers seeking to export controlled substances must acquire relevant licenses and comply with international regulations, including Drug Master Files (DMFs) registered with agencies such as the FDA.
4. European Generics Producers
European pharmaceutical companies such as Teva Pharmaceutical Industries and Sandoz (Novartis) have historically produced Meperidine hydrochloride for regional markets. However, the current market presence is limited, with many companies phasing out production due to declining demand and safety issues associated with Meperidine.
5. Contract Manufacturing Organizations (CMOs)
Numerous CMOs globally offer custom synthesis and manufacturing services for Meperidine hydrochloride, primarily serving research institutions or compounding pharmacies. These providers, including companies like HIKAL Ltd. (India) and CHI Scientific (USA), focus on small-batch, high-quality production.
Supply Chain and Distribution Considerations
Given Meperidine hydrochloride’s status as a controlled substance, supply chains encounter several hurdles:
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Regulatory Compliance: All suppliers must navigate complex licensing requirements, including DEA registration in the US and equivalent agencies globally.
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Traceability: Serialization and track-and-trace systems are essential to prevent diversion, especially for controlled substances.
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Market Demand: Global demand has waned, especially in developed countries, influencing manufacturer production volumes and market availability.
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Supply Disruptions: Factors such as regulatory changes, manufacturing shortages, or legal restrictions can impact availability, necessitating comprehensive planning for procurement.
Emerging Trends and Future Outlook
The landscape for Meperidine hydrochloride suppliers is evolving:
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Declining Medical Use: Due to safety concerns, many countries have restricted or ceased using Meperidine as a first-line analgesic, leading to decreased manufacturing volumes.
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Research and Compounding: Continued demand in research and compounding remains a niche but stable market.
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Regulatory Tightening: Increasing regulations on opioids globally may restrict manufacturing licenses, further narrowing supplier pools.
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Alternatives and Substitutes: The shift toward safer analgesics impacts long-term supplier viability, compelling suppliers to diversify portfolios.
Conclusion
While traditional giants like Pfizer and Sun Pharmaceutical continue to supply Meperidine hydrochloride within regulatory frameworks, the overall market faces contraction driven by safety issues and regulatory restrictions. Chinese and Indian generic manufacturers serve as prominent sources, especially for specialized markets. For organizations seeking to procure Meperidine hydrochloride, thorough due diligence on supplier regulatory compliance, GMP adherence, and licensing is paramount. The current landscape underscores the importance of strategic planning amidst evolving regulations and declining demand, with an emphasis on compliance and quality assurance to mitigate legal and safety risks.
Key Takeaways
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Limited but Essential Suppliers: Major pharmaceutical companies and select generics manufacturers supply Meperidine hydrochloride, mostly for research, compounding, and niche uses.
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Regulatory Environment: Strict controls and licensing requirements globally influence supply chain dynamics and market availability.
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Market Decline: Safety concerns and regulatory restrictions have led to decreased production and usage, impacting supplier diversity.
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Global Sourcing: India and China are primary regions for generic manufacturing, but due diligence is essential to ensure regulatory compliance and quality.
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Strategic Procurement: Organizations should monitor regulatory changes and secure supplies through licensed and certified suppliers, prioritizing safety and traceability.
FAQs
1. Is Meperidine hydrochloride still legally manufactured and available?
Yes. Despite a decline in medical use, Meperidine hydrochloride is still manufactured, primarily for research, compounding, and niche markets, under strict regulatory controls.
2. Which countries have the most active suppliers of Meperidine hydrochloride?
India and China are the leading producers, with several companies capable of manufacturing under GMP standards. The US and Europe have limited suppliers due to regulatory restrictions.
3. What are the primary risks associated with sourcing Meperidine hydrochloride?
Risks include regulatory non-compliance, product diversion, supply shortages, and quality variability, particularly from unlicensed or uncertified sources.
4. How can organizations ensure the quality of Meperidine hydrochloride from suppliers?
By verifying licensing, GMP certification, DMF registration, and conducting audits or audits through third-party compliance assessments.
5. Are there safer alternatives to Meperidine hydrochloride for pain management?
Yes. Alternatives include opioids like morphine, fentanyl, or non-opioid analgesics, which may offer improved safety profiles. The choice depends on clinical indication, patient profile, and regulatory considerations.
References:
- U.S. Drug Enforcement Administration. (2022). Controlled Substances Schedules.
- European Medicines Agency. (2021). List of Authorised Medicinal Products.
- Central Drugs Standard Control Organization (India). (2022). Drug License and Manufacturing Data.
- Pfizer Inc. Annual Report and Product Portfolio.
- Sun Pharmaceutical Industries Ltd. Corporate Website and Drug Approvals.
