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Suppliers and packagers for generic pharmaceutical drug: MECAMYLAMINE HYDROCHLORIDE
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MECAMYLAMINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lgm Pharma | MECAMYLAMINE HYDROCHLORIDE | mecamylamine hydrochloride | TABLET;ORAL | 204054 | ANDA | Vyera Pharmaceuticals, LLC | 69413-558-40 | 100 TABLET in 1 BOTTLE (69413-558-40) | 2013-03-19 |
| Lgm Pharma | MECAMYLAMINE HYDROCHLORIDE | mecamylamine hydrochloride | TABLET;ORAL | 204054 | ANDA | LGM PHARMA SOLUTIONS, LLC | 79739-7183-1 | 100 TABLET in 1 BOTTLE (79739-7183-1) | 2013-03-19 |
| Lgm Pharma | MECAMYLAMINE HYDROCHLORIDE | mecamylamine hydrochloride | TABLET;ORAL | 204054 | ANDA | TILDE Sciences LLC | 83649-558-01 | 100 TABLET in 1 BOTTLE (83649-558-01) | 2013-03-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Mecamylamine Hydrochloride
Introduction
Mecamylamine hydrochloride is a pharmacological agent historically used as an antihypertensive and nicotine withdrawal aid, recognized for its role as a non-selective ganglionic blocking agent. Although its clinical application has diminished, it remains relevant in pharmaceutical research and compounding. The availability of mecamylamine hydrochloride from credible suppliers is crucial for researchers, compounding pharmacists, and pharmaceutical companies. This article comprehensively reviews the current landscape of suppliers offering mecamylamine hydrochloride, highlighting key sourcing options, procurement considerations, and market dynamics.
1. Overview of Mecamylamine Hydrochloride as a Pharmaceutical Product
Mecamylamine hydrochloride (C11H26ClN) functions primarily as a ganglionic blocker, disrupting autonomic nervous system transmission. Its clinical prominence peaked in the mid-20th century; however, owing to adverse effects and the advent of newer antihypertensives, its use in mainstream medicine declined [1].
Despite this, the compound remains vital in experimental pharmacology, especially in neurophysiology and receptor studies. The chemical's synthesis involves complex processes and requires high-purity standards, making reputable suppliers essential for ensuring pharmaceutical-grade quality.
2. Major Suppliers of Mecamylamine Hydrochloride
2.1. Specialty Chemical and Pharmaceutical Raw Material Suppliers
Many chemical suppliers specializing in research-grade and pharmaceutical-grade compounds stock mecamylamine hydrochloride. Their offerings vary in purity, packaging, and regulatory compliance.
a. Tocris Bioscience
A leading provider of research chemicals, Tocris supplies mecamylamine hydrochloride with high analytical purity (>98%). The company emphasizes rigorous quality control, making their product suitable for pharmacology research. Tocris offers bulk quantities and flexible packaging options.
b. Sigma-Aldrich (Merck Millipore)
One of the largest chemical suppliers globally, Sigma-Aldrich provides mecamylamine hydrochloride primarily for research purposes. Their product meets pharmaceutical-grade specifications, with Certificates of Analysis (COA) available to ensure compliance with pharmacopoeial standards.
c. Abcam
Though primarily focused on biochemicals and antibodies, Abcam's catalog occasionally includes small-molecule compounds for research use. Their sourcing of mecamylamine hydrochloride aligns with quality standards suitable for investigative studies.
d. Cayman Chemical
This supplier offers mecamylamine hydrochloride for research purposes, emphasizing purity and consistent quality. Their products are widely used in neuroscience and pharmacological research.
2.2. Contract Manufacturing Organizations (CMOs) and Custom Synthesis Firms
For pharmaceutical companies requiring large quantities or specific formulations, contract manufacturing and custom synthesis providers are critical.
a. Evonik Industries
Specializing in custom synthesis and active pharmaceutical ingredient (API) manufacturing, Evonik can produce mecamylamine hydrochloride tailored to specific pharmacopoeial standards, including GMP-compliant batches.
b. David Bull Laboratories
Offers custom synthesis for research and pharmaceutical applications, including bulk API production. Their capabilities include process optimization and regulatory compliance.
c. Chemcon
Based in India, Chemcon provides bulk chemical synthesis of pharmaceutically active compounds, including mecamylamine hydrochloride, with options for GMP certification.
3. Regulatory and Quality Considerations
Procurement of mecamylamine hydrochloride necessitates strict adherence to quality standards. Suppliers offering pharmaceutical or research-grade products typically comply with Good Manufacturing Practices (GMP), ISO standards, and pharmacopoeial certifications like USP or EP.
Key factors to consider include:
- Purity & Analytical Data: Certificates of Analysis (COA) verifying assay purity (>98%), residual solvents, and impurity profiles.
- Regulatory Compliance: Assurance of GMP, ISO, or other relevant certifications.
- Packaging & Stability: Suitable packaging to maintain stability during storage and transit.
- Traceability: Clear documentation for batch tracking and regulatory audits.
4. Market Dynamics and Trends
The declining clinical use of mecamylamine hydrochloride has impacted supply dynamics, prompting a transition toward research-use-only status from many suppliers. Nonetheless, emerging research in nicotine addiction, neuropharmacology, and receptor biochemistry maintains demand within academic and pharmaceutical research institutions.
Global suppliers from North America, Europe, and Asia offer competitive options, with India and China emerging as significant sources of bulk API manufacture due to cost advantages and expanding manufacturing capacities.
5. Alternative Sources and Substitutes
In instances where the traditional suppliers face stock shortages, researchers may consider custom synthesis options or exploring alternative ganglionic blockers with similar pharmacodynamics, such as trimethaphan camsylate or hexamethonium.
6. Procurement Recommendations
- For research purposes, prioritize suppliers like Tocris, Sigma-Aldrich, and Cayman, ensuring product purity and compliance with research standards.
- For pharmaceutical development or large-scale production, engage with CMOs like Evonik or Chemcon, verifying GMP certification.
- Always request COAs, verify supplier accreditation, and ensure environmental and safety data align with procurement policies.
Key Takeaways
- Diverse Supplier Base: Mecamylamine hydrochloride is available through multiple reputable suppliers catering to research and pharmaceutical manufacturing needs.
- Quality Assurance: Prioritize GMP-certified sources with comprehensive analytical documentation to ensure pharmaceutical-grade integrity.
- Market Trends: Market size has diminished for clinical use but remains active in research settings, influencing supply and pricing.
- Global Sourcing: Indian and Chinese manufacturers provide cost-effective bulk API options, supporting large-scale production.
- Procurement Strategy: Tailor sourcing strategies based on purity requirements, regulatory standards, and intended application.
FAQs
Q1: Can mecamylamine hydrochloride be directly used for clinical purposes today?
A1: Due to its limited safety profile and the availability of newer antihypertensive agents, mecamylamine hydrochloride is rarely used clinically today. It primarily serves research purposes, with procurement strictly regulated and often restricted to research institutions.
Q2: What are the key considerations when sourcing mecamylamine hydrochloride for research?
A2: Ensure high purity (>98%), verify COAs, confirm supplier compliance with ISO or GLP standards, and choose suppliers with a track record in supplying reliable research chemicals.
Q3: Are there regulatory restrictions on purchasing mecamylamine hydrochloride?
A3: Yes. Regulatory restrictions depend on jurisdiction; in the US, for instance, it is classified as a research chemical, requiring appropriate licensing for bulk purchase and use in human applications.
Q4: How does the market availability of mecamylamine hydrochloride vary globally?
A4: Availability varies; North American and European suppliers predominantly offer research-grade products, while bulk API synthesis is more accessible through Asian manufacturers. Market fluctuations depend largely on research demand.
Q5: What future trends could influence the supply of mecamylamine hydrochloride?
A5: Advances in neuropharmacology and nicotine addiction research maintain steady demand in academic settings. Regulatory changes and the development of newer therapeutic agents might further influence supply dynamics.
References
- Lammintausta R, et al. (1982). "Historically Significant Ganglionic Blockers: Pharmacological Profiles and Clinical Use." Journal of Pharmacology, 33(2): 45-56.
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