5-ALA HCl
(5-Aminolevulinic acid HCl)
CAS: 5451-09-02
General information
- Appearance: white crystals
- Product Attributes: hygroscopic, highly soluble in water
- Initial Approval of FDF: 2007 (Gliolan®)
- Dosage form: topical, oral
- Indication: tumor diagnosis and tumor treatment (e.g. actinic keratosis, basal cell cancer, malignant glioma)
Your Benefits
- European Manufacturer
- Minimum 60 months product stability at controlled room temperature
- No special storage and transport conditions
- Campaign production and warehousing
- Flexible drum sizes available on request
Midas own IP Product Information
- CMO: Procos S.p.A, Italien
- Manufacturing Site: Via G. Matteotti, 249, 28062 Cameri (NO), Italy
- Campaign Production: 200–400 kg every second year
- Batchsize: 100 kg
- Lead Time: 2 months from stock, 12 months for new campaign
- Samples: standard size 50 g, commercial material, availability upon request
- Specification: DAB, USP, Midas Specification
- Available regulatory documentations: ASMF, US-DMF, DIFA, Canada, Switzerland, UK, Türkiye
- Stability Data: 60 months: 5 °C and 25 °C / 60 % RH, 6 months: 40 °C / 75 % RH
Technical Facts
- Packaging size: variable packaging 50 g – 25 kg
- Packaging: special protection against light and humidity using additional aluminum-coated PE bag, finally placed in PE drum
- Route of Synthesis: synthetic
- Excellent flowability
Talk to our API expert
Dr. Matthias Hassemer
Custom Synthesis & Technology Transfer
Head of Product Management
Midas Pharma GmbH
Rheinstr. 49
55218 Ingelheim
Germany
Rheinstr. 49
55218 Ingelheim
Germany