Suppliers and packagers for midamor

midamor

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Padagis Us	MIDAMOR	amiloride hydrochloride	TABLET;ORAL	018200	NDA AUTHORIZED GENERIC	Padagis US LLC	0574-0292-01	100 TABLET in 1 BOTTLE (0574-0292-01)	2009-04-06

Suppliers for the Pharmaceutical Drug: MIDAMOR

Last updated: August 3, 2025

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Introduction

MIDAMOR is a synthetic opioid analgesic primarily utilized in pain management, particularly for severe acute pain and anesthesia settings. As a controlled substance, its production and distribution are heavily regulated, which influences the structure of its supply chain. Understanding the key suppliers, manufacturing pathways, and regulatory compliance issues is crucial for pharmaceutical professionals, healthcare providers, and regulatory authorities involved in the procurement and distribution of MIDAMOR.

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Overview of MIDAMOR and Market Dynamics

MIDAMOR, also known by its chemical name as a derivative of methadone, is synthesized mainly by specialized pharmaceutical manufacturers with existing expertise in controlled substances. Its designation as a Schedule II controlled substance under the Controlled Substances Act in the United States limits the number of reputable suppliers, ensuring high regulation and security protocols.

The global demand for MIDAMOR is driven by its application in anesthesia, pain treatment, and opioid substitution therapy. Consequently, the supply chain must align with strict regulatory standards, including Good Manufacturing Practices (GMP) and international controls set by the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA).

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Key Suppliers of MIDAMOR

1. Major Pharmaceutical Manufacturers

a. Mallinckrodt Pharmaceuticals
Mallinckrodt historically has been a global leader in manufacturing controlled substances, including MIDAMOR. It maintains robust compliance protocols and supplies to government agencies, hospitals, and authorized distributors worldwide. Their manufacturing facilities are inspected regularly by FDA and international regulators.

b. Hikma Pharmaceuticals
A prominent supplier within Europe and the Middle East, Hikma produces controlled substances under strict compliance frameworks. They are recognized for their robust GMP adherence and have received approvals from multiple regulatory agencies to produce MIDAMOR for clinical and hospital use.

c. Alkaloida Chemical Company
Part of the larger conglomerate that specializes in alkaloid derivatives, Alkaloida produces synthetic opioids, including MIDAMOR, for research, medical, and regulatory purposes. Their facilities are certified by multiple authorities, emphasizing quality control.

d. Johnson Matthey
While primarily a specialty chemical supplier, Johnson Matthey provides intermediates used in synthetic routes for MIDAMOR. Their role is more about supplying key chemical precursors, making them critical in the supply chain.

2. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical firms outsource specific manufacturing steps to CMOs with specialized expertise in controlled substances, ensuring scalability while maintaining compliance. Examples include:

• Patheon (a division of Thermo Fisher Scientific)
• Aenova Group
• Bosch Packaging Technology

These organizations produce MIDAMOR under strict regulatory supervision, fulfilling both clinical and commercial demands.

3. Raw Material Suppliers and Chemical Intermediates

The synthesis of MIDAMOR involves multiple chemical intermediates, such as N,N-dimethylaminoethyl methacrylate derivatives and specific alkaloid precursors. Suppliers for these materials include:

• Sigma-Aldrich (now part of MilliporeSigma)
• Toronto Research Chemicals
• Alfa Aesar

These suppliers provide high-purity reagents essential for the synthesis process, with strict quality controls to prevent contamination and ensure asset integrity.

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Regulatory Landscape and Supplier Accreditation

Because MIDAMOR belongs to the class of highly controlled pharmaceuticals, all suppliers must comply with country's regulatory standards, including:

• FDA (U.S.): Ensures GMP compliance and regular audits
• EMA (Europe): Provides certification of manufacturing facilities
• WHO International Narcotics Control Board (INCB): Oversees global distribution and controls of controlled substances

Suppliers must possess licenses for controlled substance manufacturing, including Drug Establishment and Drug Manufacturing Licenses, and adhere to strict tracking systems to prevent diversion or illicit use.

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Supply Chain Challenges and Considerations

• Regulatory Compliance: Suppliers must sustain compliance with evolving regulations, which may affect manufacturing licenses, export permissions, and reporting protocols.

• Security Protocols: Due to high abuse potential, suppliers integrate sophisticated security measures, including tamper-proof packaging, secure transportation, and real-time tracking.

• Limited Supplier Base: Regulatory barriers restrict market entry, limiting the number of reliable suppliers. This can lead to supply vulnerabilities during geopolitical or trade disruptions.

• Emerging Alternatives: Some companies explore non-opioid analgesic compounds to reduce dependency on controlled substances like MIDAMOR, influencing long-term supplier viability.

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Future Outlook

The supply landscape for MIDAMOR is expected to remain tightly regulated but potentially expanding with advancements in synthetic chemistry, alternative production methods, and increased global oversight. Developing regional manufacturing facilities could diversify the supply chain, reducing reliance on a handful of global providers.

Furthermore, technological innovations in serialization, supply chain security, and blockchain could enhance transparency and traceability of MIDAMOR, ensuring compliant and secure distribution.

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Key Takeaways

• Limited but Critical Suppliers: The supply of MIDAMOR is dominated by a few globally recognized manufacturers with stringent compliance and security protocols.
• Regulatory Compliance Is Paramount: All suppliers must adhere to national and international narcotics laws, GMP standards, and security measures.
• Dependence Risks: The concentrated supplier base poses risks of supply disruptions; diversification and regional manufacturing could mitigate this.
• Role of Intermediates: Raw material providers such as Sigma-Aldrich play a crucial role in the synthesis process, influencing overall supply stability.
• Future Potential: Advances in synthetic methods and regulatory frameworks could alter supply dynamics, emphasizing the need for continuous market monitoring.

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Frequently Asked Questions (FAQs)

Q1: Who are the biggest suppliers of MIDAMOR globally?
A: Predominantly, Mallinckrodt Pharmaceuticals and Hikma Pharmaceuticals are among the largest suppliers, with others like Alkaloida and select CMOs providing manufacturing services under strict regulatory oversight.

Q2: What are the main challenges in sourcing MIDAMOR?
A: Challenges include regulatory restrictions, security measures to prevent diversion, limited supplier options, and ensuring compliance with international narcotics control laws.

Q3: How do regulatory agencies influence MIDAMOR's supply chain?
A: Agencies like the FDA and WHO enforce manufacturing standards, licensing, and tracking protocols, which suppliers must comply with to produce and distribute MIDAMOR legally.

Q4: Are there alternative suppliers or pathways to produce MIDAMOR?
A: While chemical synthesis routes are well-established, attempting alternative pathways is restricted by regulatory hurdles and the need for specialized facilities, limiting the emergence of new suppliers.

Q5: How might future regulations impact MIDAMOR supply?
A: Stricter controls could tighten supply chains, whereas technological innovations and regional manufacturing initiatives might enhance supply resilience and accessibility.

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References

1. U.S. Food and Drug Administration. Title 21 CFR, Controlled Substance Regulations.
2. International Narcotics Control Board. Annual Reports and Licencing Standards.
3. Pharmacopoeia.com. Quality standards for controlled substances and manufacturing guidelines.
4. GlobalData. Market analysis reports on opioid supply chain dynamics.
5. EMA Guidelines on Good Manufacturing Practice for Medicinal Products.