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Suppliers and packagers for generic pharmaceutical drug: BETAINE
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BETAINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Eton | BETAINE | betaine | FOR SOLUTION;ORAL | 210508 | ANDA | Eton Pharmaceuticals, Inc. | 71863-115-18 | 180 g in 1 BOTTLE (71863-115-18) | 2022-01-28 |
| Novitium Pharma | BETAINE | betaine | FOR SOLUTION;ORAL | 214864 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0352-81 | 180 g in 1 BOTTLE (0713-0352-81) | 2022-11-04 |
| Recordati Rare | CYSTADANE | betaine | FOR SOLUTION;ORAL | 020576 | NDA | Recordati Rare Diseases | 52276-400-01 | 180 g in 1 BOTTLE (52276-400-01) | 1996-10-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Betaine
Introduction
Betaine, also known as trimethylglycine, is a naturally occurring compound widely used in pharmaceutical, nutritional, and cosmetic applications. Its role as an osmolyte, methyl donor, and potential therapeutic agent has driven demand across various sectors. Identifying reliable suppliers of pharmaceutical-grade betaine is crucial for formulation development, manufacturing, and quality assurance.
This comprehensive analysis examines the key suppliers globally, their product offerings, quality standards, and market positioning. It aims to serve as a strategic resource for pharmaceutical companies, contract manufacturers, and other stakeholders seeking dependable betaine sources.
Overview of Betaine and Its Pharmaceutical Applications
Betaine’s primary functions in pharmaceuticals include hepatoprotective, anti-inflammatory, and cardioprotective properties. It is used as an active pharmaceutical ingredient (API), excipient, or supplement additive. The compound is available in various grades—pharmaceutical, food, or cosmetic—each subject to specific purity and safety standards, such as the United States Pharmacopeia (USP) and European Pharmacopoeia (EP).
Growing demand is driven by global health trends, including liver health management and cardiovascular disease treatment. Consequently, reputable suppliers focus on high-purity, bioequivalent, and regulatory-compliant betaine products.
Leading Suppliers of Pharmaceutical-Grade Betaine
1. Danisco (DuPont Nutrition & Health)
Overview:
Danisco, now part of DuPont, has historically been a prominent manufacturer of betaine derivatives, including pharmaceutical-grade betaine. Their betaine products comply with USP and EP standards, with rigorous quality control.
Product Portfolio:
- Betaine Anhydrous (≥99% purity)
- Betaine Liquid Solutions
- Specialty derivatives for pharmaceutical formulations
Supply Capabilities:
- Extensive global distribution network
- Technical support for formulation improvement
- GMP-compliant manufacturing facilities
Market Position:
Ken to deliver consistent high-quality betaine, Danisco caters primarily to large pharmaceutical and nutraceutical companies. They emphasize sustainable sourcing and rigorous testing protocols aligned with international standards.
2. Jiahe Biotech
Overview:
Jiahe Biotech, headquartered in China, is a leading manufacturer of betaine, with a focus on pharmaceutical and food-grade products. Their betaine is derived from natural sources and adheres to pharmacopeial standards.
Product Portfolio:
- Pharmaceutical-grade Betaine Anhydrous (≥98%)
- Food-grade Betaine (for dietary supplements)
- MBTC (Methyl donor derivatives)
Supply Capabilities:
- High-volume manufacturing aligned with GMP standards
- Custom packaging solutions
- Certification for international markets (ISO, SGS, GMP)
Market Position:
Jiahe Biotech is recognized for cost competitiveness and high-volume exports, serving clients across Asia, North America, and Europe.
3. Zhejiang Medicine Co., Ltd.
Overview:
Zhejiang Medicine is a comprehensive pharmaceutical manufacturer with a significant portfolio in bulk intermediates and APIs, including betaine.
Product Portfolio:
- Pharmaceutical-grade Betaine Anhydrous (≥99%)
- Betaine in powder and liquid forms
- Related methyl donors for API synthesis
Supply Capabilities:
- Good manufacturing practices (GMP) compliance
- Robust R&D and quality assurance systems
- Long-term supply agreements with global pharma firms
Market Position:
Known for reliable quality and competitive pricing, Zhejiang Medicine expands its footprint through strategic alliances and continuous process improvements.
4. Chengdu Shuangliu Zikang Pharmaceutical Co., Ltd.
Overview:
Specializing in amino acids and related compounds, Chengdu Zikang produces high-purity betaine suitable for pharmaceutical manufacturing.
Product Portfolio:
- Pharmaceutical Betaine (≥99%)
- Technical-grade Betaine (lower purity options)
- Customized formulations
Supply Capabilities:
- GMP-certified manufacturing facilities
- Strict control over raw material sourcing
- Certifications aligned with international standards
Market Position:
The company emphasizes product purity and regulatory compliance, positioning itself as a dependable supplier for manufacturers seeking pharmaceutical-grade betaine.
5. Hebei Huachen Pharmaceutical Co., Ltd.
Overview:
Hebei Huachen manufactures a variety of amino acids and osmolytes, including betaine, serving pharmaceuticals and dietary supplement markets.
Product Portfolio:
- Betaine Anhydrous Pharmaceuticals Grade
- Betaine Liquid Solutions
- Packaged for bulk and specialty batches
Supply Capabilities:
- Large-scale GMP production facilities
- Strict quality control and traceability
- Global distribution network
Market Position:
Offering competitive pricing and reliable supply, Hebei Huachen has established itself as a critical global supplier, especially in Asian markets.
Quality Standards and Regulatory Considerations
Pharmaceutical-grade betaine must meet strict regulatory standards, including USP, EP, and JPE (Japanese Pharmacopoeia). Suppliers typically adhere to cGMP (current Good Manufacturing Practices) to ensure product consistency, purity, and safety.
Key quality attributes include:
- Purity ≥98-99%
- Absence of residual solvents and heavy metals
- Certification of analysis (COA) and batch-to-batch consistency
- Compliance with international regulations for drug substances
Importantly, suppliers often provide Documentation of Origin, Certificates of Analysis, and stability data to support regulatory submissions.
Emerging Trends and Market Dynamics
The global betaine market for pharmaceuticals is expanding, driven by increased prevalence of liver and cardiovascular conditions, along with rising popularity in dietary supplements. Trends influencing supplier strategies include:
- Natural Sourcing: Preference for plant or microbial-derived betaine to meet consumer and regulatory demands for natural ingredients.
- Process Innovation: Adoption of sustainable extraction and purification methods to reduce environmental impact.
- Regulatory Scrutiny: Increasing standards for impurity profiles and traceability.
- Geographical Diversification: Growth of supply chains in China, India, and Southeast Asia to meet rising demand.
Key Considerations for Stakeholders
- Supplier Certification: Verify GMP, ISO, and pharmacopoeial compliance.
- Purity and Specifications: Confirm batch purity, residual solvent levels, heavy metal limits.
- Supply Security: Assess production capacity, lead times, and distribution logistics.
- Cost Factors: Balance quality with pricing, considering total cost of ownership.
- Regulatory Support: Ensure supplier provides necessary documentation for regulatory filings.
Conclusion
The competitive landscape for pharmaceutical-grade betaine features a mix of established multinational corporations and emerging suppliers primarily based in China and Asia. While organizations like DuPont and Zhejiang Medicine maintain high standards and extensive regulatory compliance, regional players like Jiahe Biotech and Chengdu Zikang offer cost-effective options with high purity.
Selection of a betaine supplier must hinge upon rigorous quality standards, regulatory compatibility, and supply chain reliability to support pharmaceutical development and manufacturing.
Key Takeaways
- Pharmaceutical-grade betaine suppliers must adhere to strict regulatory standards, including USP and EP specifications.
- Established global leaders like DuPont and regional manufacturers in China and Asia dominate the market, offering diverse product options.
- Rigorous quality assurance, including certificates of analysis and compliance with GMP, is critical in supplier selection.
- Trends favor natural sourcing, sustainability, and regulatory transparency, influencing supplier strategies.
- Cost efficiency should be balanced with quality, ensuring secure supply chains for pharmaceutical applications.
FAQs
Q1: What are the primary quality standards for pharmaceutical betaine?
A1: The key standards include the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). Suppliers must meet specified purity levels (typically ≥98-99%), with rigorous testing for residual solvents, heavy metals, and microbiological contamination.
Q2: Which regions dominate the supply of pharmaceutical betaine?
A2: China leads as the primary producer and exporter, supported by manufacturers in India, Southeast Asia, and some European countries. North America and Europe mainly import and distribute high-quality betaine for pharmaceutical use.
Q3: How do natural vs. synthetic betaine sources differ for pharmaceutical applications?
A3: Natural betaine is derived from sugar beet or processed from microbial fermentation, often preferred for its natural labeling and consumer acceptance. Synthetic betaine is produced through chemical synthesis pathways. Both must meet pharmacopoeial standards for pharmaceutical use, but natural sources may align better with market trends towards "natural" ingredients.
Q4: What are the key factors influencing supplier selection for betaine?
A4: Factors include product purity, manufacturing compliance (GMP), certification, supply capacity, cost, lead times, and regulatory documentation. Reliability and traceability are critical for pharmaceutical applications.
Q5: Can betaine be used interchangeably in pharmaceutical formulations from different suppliers?
A5: While chemically identical, product quality, excipient compatibility, and purity standards vary. Formulation stability and efficacy depend on consistent raw material quality; thus, comprehensive qualification processes are essential when switching suppliers.
Sources:
[1] Global Betaine Market Report, 2022.
[2] United States Pharmacopeia (USP) Monograph on Betaine.
[3] European Pharmacopoeia (EP) Standards for Betaine.
[4] DuPont Nutrition & Health Product Catalog.
[5] Jiahe Biotech Company Website Documentation.
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