| Product Name | 5-Aminolevulinic Acid Hydrochloride Powder |
| Grade | Food Grade |
| Certification | HACCP/ISO 22000/HALAL/IS0 9001 |
| Specification | 99%Pure |
| Appearance | Light Yellow powder |
| Delivery Time | 7 days |
| Nutrient Content | Vegan, Gluten-Free, Non-GMO, Natural |
| Shelf Life | 2 Years |
| Storage | Cool Dry Place |
5-ALA HCl is widely used in pharmaceuticals, nutraceuticals, and agricultural biostimulants due to its enhanced stability and water solubility compared to free 5-ALA. In medicine, it is utilized as a photosensitizing agent in PDT for cancer treatment, particularly for skin and bladder cancers, where it selectively accumulates in tumor cells and induces cytotoxicity upon light activation. Additionally, it is incorporated into dietary supplements for fatigue reduction, liver health, and metabolic support.
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Medical Grade Purity and Regulatory Approvals
5-ALA HCl is a FDA-approved photosensitizer for optical imaging in glioma surgery (2017) and is EU-approved for photodynamic therapy (PDT) in actinic keratosis and skin cancers . Its GRAS status for dietary supplements further enables market entry in functional foods and nutraceuticals . Unlike the free acid form, the hydrochloride salt offers consistent batch-to-batch purity (≥98% HPLC) and stability under controlled storage (2–8°C), meeting strict pharmaceutical standards .
Superior Solubility and Targeted Activation
pH-Independent Solubility: Soluble in water (34 mg/mL) and DMSO, enabling diverse formulations for injectables, topical creams, and oral solutions .
Enzymatic Activation: Converts intracellularly to protoporphyrin IX (PpIX), a photosensitizer that accumulates preferentially in rapidly dividing cells (e.g., tumors), minimizing systemic toxicity .
Enhanced Bioavailability: Clinical studies show 5-ALA HCl achieves 2–3× higher PpIX levels in tumors compared to the free acid, improving PDT efficacy .
Cost-Effective and Scalable Production
Fermentation-Driven Efficiency: Industrial production via microbial fermentation (e.g., Rhodobacter sphaeroides) yields ≥98% pure 5-ALA HCl at costs 30–50% lower than synthetic routes .
Waste Valorization: Utilizes soapstock (a vegetable oil byproduct) as feedstock, aligning with circular economy principles .
Economies of Scale: Bulk pricing at $150–$200/kg vs. $300–$400/kg for premium PDT precursors like porfimer sodium .
Emerging Applications and Technological Innovation
Combination Therapies: Preclinical studies show 5-ALA HCl-PDT synergizes with immunotherapies (e.g., anti-PD-1 antibodies), increasing tumor apoptosis by 40% .
Nanomedicine Delivery: Liposomal formulations (e.g., LipiSperse) improve bioavailability by 3-fold and reduce systemic side effects .
Precision Agriculture: IoT-integrated fertigation systems using 5-ALA HCl optimize crop stress responses, tapping into the $8B smart farming market .
Safety and Tolerability
Low Toxicity: Oral LD₅₀ >2 g/kg in rodents, with minimal skin irritation. Clinical trials report transient nausea in <5% of participants .
GRAS and Kosher/Halal Certification: Synthetic production (no animal-derived components) ensures compliance with dietary restrictions .
Market Growth and Strategic Positioning
High-Growth Market: The 5-ALA HCl drugs market is projected to reach $1.02B by 2029, driven by rising cancer incidence and adoption of PDT .
Global Reach: Approved in >40 countries, with North America and Europe accounting for 60% of revenue .
Intellectual Property: Companies like SBI Pharma hold patents for fermentation-based production, ensuring cost leadership and sustainability .
Established in 2006, we are a certified OEM/ODM manufacturer specializing in premium health supplements. Holding NSF-GMP,HACCP, ISO 22000, USDA Organic, EU Organic, Halal, and FDA certifications, our facility integrates advanced technologies for tablet, capsule, powder, gummy, and softgel production. From formulation to packaging, we provide full-cycle solutions with strict quality protocols, including raw material traceability, third-party lab testing, and Halal-compliant dedicated lines. Serving global markets including North America, Europe, and Asia, we prioritize sustainability through eco-friendly processes and transparent labeling. With 19+ years of expertise, we empower brands to deliver scientifically validated, certification-backed nutraceuticals tailored to diverse regulatory and cultural requirements 
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