Crotamiton
Drug Substance / API
General Information
- CAS: 483-63-6
- Appearance: colorless to pale yellow liquid
- Product Attributes: oily liquid
- Initial Approval of FDF: 1948
- Dosage Form: topical
- Indication: antiparasite, scabicidal and antipruritic agent
Your Benefits
- European manufacturer
- Minimum 60 months product stability at controlled room temperature
- No special storage and transport conditions
- Up-to-date documentation
- Starting material sourced from EU
Midas own IP Product Information
- CMO: EGIS Pharmaceuticals PLC
- Manufacturing Site: Keresztúri út 30–38, 1106 Budapest, Hungary
- Campaign Production: several mt
- Batch Size: about 800 kg
- Lead Time: 3 months from stock, 12 month for new campaign
- Samples: standard size 200 g, availability upon request
- Specification: CEP, USP, CP
- Available Regulatory Documentation: CEP, US-DMF, CN-DMF
- Stability Data: 60 months: 25 °C / 60 % RH and 30 °C / 75 % RH, 6 months: 40 °C / 75 % RH
Technical Facts
- Packaging Size: 23 kg
- Packaging: in 30 L HDPE blue canister
- Route of Synthesis: synthetic
Talk to our Expert
Dr. Matthias Hassemer
Marketing & Sales
Director Product Management
Rheinstr. 49
55218 Ingelheim
Germany
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