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Suppliers and packagers for generic pharmaceutical drug: L-GLUTAMINE
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L-GLUTAMINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Emmaus Medcl | ENDARI | l-glutamine | FOR SOLUTION;ORAL | 208587 | NDA | Emmaus Medical, Inc. | 42457-420-60 | 60 PACKET in 1 CARTON (42457-420-60) / 1 POWDER, FOR SOLUTION in 1 PACKET (42457-420-01) | 2017-07-07 |
| Novitium Pharma | L-GLUTAMINE | l-glutamine | FOR SOLUTION;ORAL | 215647 | ANDA | ANI Pharmaceuticals, Inc. | 70954-417-20 | 60 PACKET in 1 CARTON (70954-417-20) / 1 POWDER, FOR SOLUTION in 1 PACKET (70954-417-10) | 2024-07-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: L-GLUTAMINE
Introduction
L-Glutamine, a non-essential amino acid, has garnered significant attention within both the pharmaceutical and nutritional supplement sectors owing to its roles in cellular metabolism, immune function, and gastrointestinal health. As demand surges across clinical, sports nutrition, and supplement markets, understanding current suppliers for pharmaceutical-grade L-glutamine becomes vital for stakeholders across supply chains. This report provides a comprehensive overview of key suppliers, their manufacturing capacities, quality standards, and market positioning to equip business professionals with actionable insights.
Market Overview of L-Glutamine Supply
L-Glutamine's global market is expanding, driven by therapeutic applications such as recovery from chemotherapy-induced mucositis, wound healing, and immune support, as well as sports nutrition. The purification of pharmaceutical-grade L-glutamine demands stringent GMP compliance, stability, and high purity (≥99%). Leading suppliers operate across North America, Europe, and Asia, with production often consolidated within regions boasting advanced regulation frameworks and manufacturing innovations.
Major Suppliers of Pharmaceutical-Grade L-Glutamine
1. Ajinomoto Co., Inc.
Overview: A Japanese multinational with longstanding expertise in amino acids, Ajinomoto is a predominant supplier of pharmaceutical-grade L-glutamine. Their GRAS (Generally Recognized As Safe) certification and adherence to global GMP standards position them as a primary choice.
Manufacturing & Quality Certifications: ISO 9001, ISO 22000, ISO 13485, and compliance with US Pharmacopeia (USP) standards. Their L-glutamine is produced via fermentation of glutamic acid, ensuring high purity and bioavailability.
Market Presence: Supplies to pharmaceutical manufacturers, nutraceutical companies, and research institutions worldwide. Their global distribution network enables consistent supply to North America, Europe, and Asia-Pacific.
2. Ajinomoto Health & Nutrition North America, Inc.
As a subsidiary, this division focuses on North American markets, providing pharmaceutical-grade L-glutamine with tailored formulations for clinical and nutritional applications.
3. Evonik Industries AG
Overview: A German specialty chemicals company, Evonik supplies high-purity amino acids, including L-glutamine, primarily for pharmaceutical and biotech industries.
Quality & Compliance: Their products meet stringent pharmacopoeia standards and are produced in FDA- and EMA-compliant facilities, emphasizing quality assurance through batch testing and traceability.
Key Advantages: Their manufacturing process ensures minimal impurities, and their global logistics infrastructure supports timely supply chains.
4. Ajinomoto Pharma Solutions (formerly CJ America Inc.)
Profile: Focused on pharmaceutical ingredients, this division supplies high-grade amino acids with a focus on injectable and parenteral formulations. They leverage fermentation technology for purity and consistency.
5. Shaanxi Fuheng (FHG) Bio-Technology Co., Ltd.
Overview: Based in China, FHG offers competitive pricing for pharmaceutical-grade amino acids, including L-glutamine. Their GMP-compliant facilities and accelerated manufacturing capacity support large-volume orders.
Certifications: ISOs and Chinese pharmacopoeia standards compliance.
6. Jiangsu Suyuan Bio-Tech Co., Ltd.
Profile: A Chinese supplier with a focus on amino acids for pharmaceutical and nutritional purposes. They maintain GMP standards and export significant quantities globally.
Emerging and Niche Suppliers
7. Meihua Group
A key Chinese producer of amino acids, including L-glutamine, with a focus on pharmaceutical-grade products, adhering to ISO standards and expanding global distribution.
8. Kemira Chemicals
Specializes in amino acid manufacturing with a focus on specialty grades suitable for clinical research and pharmaceutical formulations.
Key Selection Criteria for Suppliers
- Quality & Purity Standards: ISO, GMP, USP, EP, JP standards.
- Manufacturing Capacity: Ability to meet large volume demands with consistent quality.
- Regulatory Compliance: Certification for global markets, including FDA, EMA, and other regional agencies.
- Traceability & Batch Consistency: Critical for pharmaceutical applications to ensure safety and efficacy.
- Supply Chain Reliability: Proven logistics and capacity for timely delivery, especially amidst global supply chain disruptions.
Current Trends Influencing L-Glutamine Suppliers
- Fermentation Technology: Increasing reliance on bio-fermentation over chemical synthesis for enhanced purity and sustainability.
- Regulatory Stringency: Stricter GMP standards in response to quality concerns driven by pharmacovigilance.
- Supply Chain Diversification: Pharmaceutical companies seeking diversified suppliers to mitigate geopolitical and logistical risks.
- Price Competition: Chinese suppliers offering competitive pricing, prompting global firms to assess trade-offs regarding quality assurances.
Conclusion
Securing reliable suppliers for pharmaceutical-grade L-glutamine necessitates evaluating quality certifications, manufacturing capacity, regulatory compliance, and supply chain resilience. Established players like Ajinomoto and Evonik remain market leaders due to their rigorous quality standards and global presence, while emerging Chinese manufacturers offer competitive pricing but require thorough vetting for regulatory compliance.
Key Takeaways
- Prioritize Regulatory Compliance: Choose suppliers compliant with GMP, USP, and international pharmacopoeia standards to ensure safety and efficacy.
- Assess Manufacturing Capabilities: Large-scale, consistent production is critical for meeting pharmaceutical demand without quality lapses.
- Evaluate Supply Chain Stability: Diversify supplier base to mitigate risks from geopolitical or logistical disruptions.
- Leverage Fermentation Technology: Opt for suppliers utilizing advanced bio-fermentation processes ensuring high purity and sustainability.
- Monitor Emerging Markets: Chinese suppliers are becoming prominent; due diligence on certifications and quality controls remains essential.
FAQs
Q1: What are the key quality certifications I should look for in pharmaceutical-grade L-glutamine?
A1: Look for ISO certifications, GMP compliance, and adherence to pharmacopeia standards such as USP, EP, or JP to ensure high purity and safety.
Q2: How does fermentation technology influence L-glutamine quality?
A2: Fermentation produces high-purity L-glutamine with fewer impurities, enhancing bioavailability and reducing the risk of adverse reactions, making it preferred for pharmaceutical applications.
Q3: Are Chinese suppliers reliable for pharmaceutical-grade L-glutamine?
A3: Many Chinese suppliers meet stringent GMP and ISO standards, but due diligence is essential. Confirm certifications, conduct audits, and assess supply chain reliability before procurement.
Q4: What are the typical lead times for sourcing pharmaceutical-grade L-glutamine?
A4: Lead times vary from 4 to 12 weeks depending on supplier capacity, order scale, and regulatory clearance, emphasizing the importance of early engagement.
Q5: How is the trend toward bio-fermentation shaping the supply of pharmaceutical L-glutamine?
A5: Bio-fermentation enhances product purity, sustainability, and scalability, making it the predominant technology among leading suppliers and influencing market standards.
References
- Ajinomoto Co., Inc. – Product documentation and quality standards.
- Evonik Industries AG – Corporate filings and GMP certifications.
- Chinese amino acid manufacturers’ regulatory filings and GMP adherence reports.
- Market research reports on amino acids and pharmaceutical ingredients.
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