We needs full documentation as per pharmaceutical/API qualification standards. The list is below:
Registration certificate
GMP certificate (API name must be mentioned)
Manufacturing license
Specifications (USP / Ph. Eur / JP / CTD DMF)
Drug Master File (DMF)
Particle size & bulk density information
Stability data (accelerated & long term)
Trial order sample with COA (minimum two batches with full QC analysis and expiry/retest data)
MSDS (Material Safety Data Sheet)
ISO 9001 certificate
Residual solvents statement
Elemental impurities statement
BSE/TSE statement
Allergen statement
Storage condition details
Spot statement
Nitrosamines statement
Letter of commitment to inform in case of any change in material
We also wish to sign an NDA (Non-Disclosure Agreement) with you before moving forward for safe business cooperation.
Kindly confirm:
If you can supply Glycerin with all documents as listed above,
Your best price quotation,
Delivery time required
Other commercial terms.
We are interested in a long-term partnership and would be happy to discuss further once we receive your confirmation.