Suppliers and packagers for DEHYDRATED ALCOHOL
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DEHYDRATED 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 |
|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | DEHYDRATED ALCOHOL | alcohol | SOLUTION;INTRA-ARTERIAL | 217845 | ANDA | Accord Healthcare, Inc. | 16729-710-45 | 10 VIAL in 1 CARTON (16729-710-45) / 5 mL in 1 VIAL (16729-710-31) | 2025-06-25 |
| Breckenridge | DEHYDRATED ALCOHOL | alcohol | SOLUTION;INTRA-ARTERIAL | 219444 | ANDA | Breckenridge Pharmaceutical Inc | 51991-999-17 | 10 VIAL, GLASS in 1 CARTON (51991-999-17) / 5 mL in 1 VIAL, GLASS (51991-999-75) | 2025-09-23 |
| Ingenus Pharms Llc | DEHYDRATED ALCOHOL | alcohol | SOLUTION;INTRA-ARTERIAL | 219569 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-539-10 | 10 VIAL, GLASS in 1 CARTON (50742-539-10) / 5 mL in 1 VIAL, GLASS (50742-539-01) | 2025-07-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Dehydrated Alcohol
Introduction
Dehydrated alcohol, also known as absolute alcohol or anhydrous ethanol, is a critical solvent and active ingredient in the pharmaceutical industry. It is extensively used for manufacturing disinfectants, antiseptics, and various drug formulations requiring high purity ethanol free of water. The demand for dehydrated alcohol is driven by stringent regulatory standards ensuring high purity, stability, and consistency in pharmaceutical applications. This article provides a comprehensive overview of key suppliers globally recognized for providing high-quality dehydrated alcohol tailored to pharmaceutical needs.
Understanding Pharmaceutical-Grade Dehydrated Alcohol
Pharmaceutical-grade dehydrated alcohol must meet rigorous specifications, including purity levels (generally 99.5% or higher), low residual water content, and absence of impurities such as methanol, acetone, or other volatile compounds. Suppliers must adhere to Good Manufacturing Practices (GMP) and relevant pharmacopeial standards like the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or Japanese Pharmacopoeia (JP) to ensure product compliance.
Global Suppliers of Dehydrated Alcohol for Pharmaceuticals
1. MilliporeSigma (Merck KGaA)
Overview:
MilliporeSigma, a division of Merck Group, is a leading supplier of pharmaceutical solvents, including dehydrated ethanol. Their products are distinguished by high purity, consistent quality, and compliance with global pharmacopeial standards.
Product Offerings:
- Absolute ethanol (pharmaceutical grade), available in various container sizes.
- Customized formulations to meet specific regulatory requirements.
Quality Assurance:
Manufacturing facilities operate under ISO 9001 and GMP certifications. Their ethanol products are characterized by minimal residual water, typically less than 0.1%.
Applications:
Used extensively in antiseptic formulations, solvent extraction, and as a reagent in biotech applications.
Supply Chain:
Global distribution network facilitates timely supply to North America, Europe, and Asia.
2. Thermo Fisher Scientific
Overview:
Thermo Fisher Scientific supplies dehydrated alcohol suitable for pharmaceutical manufacturing, emphasizing high purity and regulatory compliance.
Product Offerings:
- 99.9% pure dehydrated ethanol in various sizes, including bulk quantities for industrial use.
Quality and Standards:
Products conform to USP, EP, and JP standards, ensuring suitability for sterile products and injectable formulations.
Supply Capabilities:
Dedicated manufacturing facilities ensure reliable supply chains, with strict quality controls minimizing contamination risks.
3. Sigma-Aldrich (Part of Merck Group)
Overview:
Sigma-Aldrich is renowned for supplying high-purity solvents for research and pharmaceutical manufacturing, including dehydrated ethanol.
Product Characteristics:
- Denatured and absolute ethanol grades meeting pharmacopeial standards.
- Certified for traceability, purity, and low residual water content.
Compliance and Certifications:
Strict adherence to ISO standards and pharmacopeial specifications guarantees regulatory compliance.
4. BASF SE
Overview:
BASF, a global chemical powerhouse, produces dehydrated ethanol used in pharmaceutical applications, emphasizing sustainability and quality.
Product Offerings:
- Pharma-grade dehydrated ethanol suitable for disinfectants, inhalants, and solvent applications.
Quality Standards:
Manufacturing processes adhere to GMP and ISO 9001, with rigorous testing for residual water, impurities, and microbiological contamination.
Supply Reach:
Global logistics support distribution across North America, Europe, and Asia-Pacific.
5. Croda International Plc
Overview:
Croda specializes in specialty chemicals and solvents for pharma, providing dehydrated ethanol suitable for sterile and non-sterile pharmaceutical formulations.
Product Features:
- High purity, water-free ethanol validated for pharmaceutical standards.
Regulatory Compliance:
Manufactured under strict GMP conditions, with comprehensive documentation and batch certification.
6. Local and Regional Suppliers
In addition to international giants, regional chemical and solvent suppliers often serve local markets, especially in Asia and Europe. Many of these suppliers are ISO-certified and cater to smaller batch sizes or specific formulations. Notable examples include:
- Fisher Scientific (a subsidiary of Thermo Fisher)
- VWR International
- Chemviron
Key Considerations for Selecting Suppliers
When choosing a dehydrated alcohol supplier, pharmaceutical companies should evaluate:
- Regulatory compliance (GMP, pharmacopeial standards)
- Purity specifications (water content, residual impurities)
- Source and manufacturing process transparency
- Supply reliability and capacity
- Documentation and traceability
Emerging Trends and Suppliers in Market
With increasing regulations surrounding solvent purity and sustainability, suppliers are investing in greener production methods, such as bio-based ethanol. Companies like Green Ethanol Ltd. and EcoPharma are gaining ground by offering bio-derived dehydrated alcohol certified for pharmaceutical use, aligning with sustainability goals.
Supply Chain and Geographical Considerations
Pharmaceutical manufacturers should consider regional suppliers to mitigate logistical risks and address import/export restrictions. North American and European markets are served predominantly by Merck, Thermo Fisher, and BASF, while Asian markets rely heavily on regional producers and local distributors compliant with local regulations.
Conclusion
The procurement of dehydrated alcohol for pharmaceutical applications requires meticulous selection of suppliers adhering strictly to quality, safety, and regulatory standards. Major global players such as MilliporeSigma, Thermo Fisher, Sigma-Aldrich, BASF, and Croda provide reliable sources, differing mainly in regional availability and specific product formulations. Companies should prioritize validated quality certifications, supply stability, and transparency to maintain compliance and ensure patient safety.
Key Takeaways
- Regulatory compliance is paramount: Ensure suppliers meet USP, EP, and GMP standards.
- High purity and consistent quality: Essential for pharmaceutical solvent applications, with residual water content below 0.1%.
- Global and regional supplier dynamics: Choose based on supply reliability, geographic location, and certification.
- Sustainability trends: Bio-based dehydrated ethanol is gaining prominence as an eco-friendly alternative.
- Due diligence: Verify supplier certifications, batch documentation, and testing protocols for assured quality.
FAQs
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