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Suppliers and packagers for generic pharmaceutical drug: ALCOHOL
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ALCOHOL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bpi Labs | ABLYSINOL | alcohol | SOLUTION;INTRA-ARTERIAL | 207987 | NDA | BPI Labs, LLC | 54288-105-10 | 10 AMPULE in 1 CARTON (54288-105-10) / 1 mL in 1 AMPULE (54288-105-01) | 2018-10-24 |
| Bpi Labs | ABLYSINOL | alcohol | SOLUTION;INTRA-ARTERIAL | 207987 | NDA | BPI Labs, LLC | 54288-105-15 | 10 AMPULE in 1 CARTON (54288-105-15) / 5 mL in 1 AMPULE (54288-105-02) | 2018-10-24 |
| Bpi Labs | ABLYSINOL | alcohol | SOLUTION;INTRA-ARTERIAL | 207987 | NDA | BPI Labs, LLC | 54288-144-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (54288-144-10) / 5 mL in 1 VIAL, SINGLE-DOSE (54288-144-01) | 2025-04-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Alcohol
Introduction
Alcohol, specifically in pharmaceutical contexts, primarily refers to ethanol, a versatile chemical used both as an active ingredient, disinfectant, solvent, and excipient in drug formulation. Given its widespread utility, sourcing high-quality pharmaceutical-grade ethanol is critical for manufacturers to ensure safety, efficacy, and regulatory compliance. This article explores key suppliers of pharmaceutical-grade alcohol, discusses market dynamics, quality considerations, and strategic sourcing insights vital for stakeholders in the pharmaceutical supply chain.
Market Overview of Pharmaceutical Alcohol Suppliers
The global market for pharmaceutical alcohol comprises both large multinational chemical suppliers and specialized regional producers. These suppliers adhere to strict regulatory standards, primarily Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), ensuring product purity and safety. As the demand for high-purity ethanol grows, particularly during health crises like the COVID-19 pandemic, supplier capacity and supply chain resilience have become pivotal.
Major players include chemical conglomerates, alcohol producers, and contract manufacturing organizations (CMOs). Notably, suppliers from North America, Europe, and Asia dominate the market, supplying pharmaceutical-grade ethanol globally.
Key Suppliers of Pharmaceutical-Grade Alcohol
1. Merck KGaA (Germany)
Merck offers a comprehensive portfolio of pharmaceutical solvents, including ethanol suitable for medicinal formulations and disinfectants. They adhere tightly to regulatory standards, ensuring high-purity products (typically >99.9%) suitable for injectable, oral, and topical applications.
2. Sigma-Aldrich (Part of Merck Group)
A major distributor and manufacturer, Sigma-Aldrich supplies pharmaceutical-grade ethanol standardized for laboratory and pharmaceutical use. Their ethanol products meet stringent pharmacopeial standards. Sigma maintains a global supply network capable of sourcing ethanol with various purity levels tailored to industry needs.
3. BASF (Germany)
BASF produces pharmaceutical excipients, including ethanol with high purity standards. Their ethanol products are utilized in vaccine production, disinfectants, and other therapeutic applications. BASF emphasizes sustainable and high-quality production processes compliant with international standards.
4. Shell Chemicals (Netherlands)
Shell supplies pharmaceutical-grade ethanol, primarily used as a solvent and disinfectant. Their ethanol is produced via fermentation or synthesis, meeting regulatory and purity specifications suitable for stringent pharmaceutical applications.
5. Croda International (UK)
Specializing in specialty chemicals, Croda supplies pharmaceutical-grade ethanol used in manufacturing antiseptics, sanitizers, and as a solvent in drug formulations. Their ethanol complies with pharmacopeial standards and environmental regulations.
6. Ethanol Producers in Asia
Notably, India’s Praj Industries and China’s large alcohol producers have scaled up production capabilities to meet global demand. These regional suppliers often offer competitive pricing and flexible supply terms but require rigorous quality audits and certifications.
Regional Supply Dynamics and Considerations
- North America and Europe: Home to several large-scale suppliers with advanced regulatory compliance and Quality Assurance (QA) systems. These regions are favored for their reliability and adherence to stringent standards.
- Asia: Rapidly expanding ethanol production capacity, driven by regional demand and cost competitiveness. Suppliers here may present variability in quality, underscoring the necessity for thorough qualification protocols.
- Emerging Markets: Growing local suppliers offer opportunities but necessitate comprehensive vetting to ensure product consistency and compliance with international standards.
Quality and Regulatory Standards
Pharmaceutical-grade ethanol must meet specific pharmacopeial standards—USP, EP, or JP—that specify purity, residual impurities, and alcohol content. Suppliers must provide Certificates of Analysis (CoA) demonstrating compliance with these standards.
Key quality considerations include:
- Purity (>99.9%): Essential for formulations and disinfectants.
- Residue Limits: Low levels of methanol or other contaminants.
- Stamping and Certification: Compliance with regional regulatory bodies such as FDA, EMA, or China’s NMPA.
- Container and Packaging: Compatibility to prevent contamination during storage and transport.
Strategic Sourcing and Supply Chain Considerations
- Supplier Qualification: Rigorous auditing of manufacturing practices, certifications, and supply chain integrity.
- Supply Continuity: Establish multiple supplier relationships to mitigate risks of disruption.
- Regulatory Compliance: Ensure suppliers adhere to current Good Manufacturing Practices (cGMP).
- Pricing and Contract Terms: Balance cost efficiency with quality guarantees, considering long-term contracts for stability.
- Logistics and Storage: Ensure appropriate warehousing and transportation, especially for bulk quantities requiring special handling.
Emerging Trends and Innovations
- Renewable Ethanol Production: Enhancing sustainability, with suppliers shifting towards bioethanol derived from renewable biomass.
- Particle-Free Ethanol: Reducing impurities for sensitive formulations.
- Digital Traceability: Implementing blockchain and IoT for supply transparency.
- Regional Self-Sufficiency: Countries investing in domestic ethanol production to reduce dependency on imports.
Conclusion
Securing reliable suppliers for pharmaceutical-grade alcohol remains a strategic priority for pharmaceutical manufacturers, especially amid fluctuating global supply chains. Leading global suppliers such as Merck, Sigma-Aldrich, BASF, Shell, and Croda deliver high-quality ethanol aligned with international standards. Regional producers, particularly in Asia, offer cost advantages but require diligent qualification processes. A balanced sourcing strategy emphasizing quality, compliance, and supply chain resilience ensures uninterrupted production and regulatory adherence.
Key Takeaways
- Prioritize certified, GMP-compliant suppliers: Ensuring product quality and regulatory adherence is paramount.
- Diversify supplier base: Mitigate risks linked to geopolitical or logistical disruptions.
- Comply with pharmacopeial standards: Essential for formulation safety and regulatory approval.
- Leverage regional suppliers cautiously: Conduct thorough due diligence to match quality standards.
- Invest in supply chain resilience: Secure long-term agreements and establish contingency plans.
FAQs
1. What are the main regulatory standards for pharmaceutical alcohol suppliers?
Suppliers must adhere to pharmacopeial standards such as USP, EP, or JP, and comply with regional regulatory bodies’ requirements like the FDA (USA), EMA (Europe), or NMPA (China). Certificates of Analysis and compliance documentation are critical.
2. How can pharmaceutical companies ensure ethanol quality across different suppliers?
Through rigorous qualification protocols, including audits, reviewing certifications, and demanding detailed Certificates of Analysis that confirm compliance with purity and impurity specifications.
3. What are the risks associated with sourcing ethanol from regional suppliers?
Risks include variability in product quality, regulatory non-compliance, supply chain disruptions, and potential delays. Proper qualification and verification mitigate these risks.
4. Are there environmentally sustainable options for pharmaceutical alcohol production?
Yes. Bioethanol produced from renewable biomass offers a sustainable alternative, aligning with increasingly strict environmental regulations and corporate responsibility initiatives.
5. How has demand for pharmaceutical alcohol changed post-pandemic?
Demand surged globally due to increased production of sanitizers and disinfectants, stressing supply chains and prompting investments in capacity expansion and diversification of sources.
Sources:
- [1] Merck official website, Pharmaceutical solvents portfolio.
- [2] Sigma-Aldrich product documentation, Purity standards for ethanol.
- [3] BASF Annual Report, Focus on pharmaceutical excipients production.
- [4] Shell Chemicals product datasheets, Compliance and quality standards.
- [5] Industry reports on global pharmaceutical alcohol market trends and capacity.
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