We are a drug factory from Bucharest, Romania that produces generic medicines since 1996 and we have in our portfolio about 150 marketing * are now interested to find new sources for the active ingredients we use in manufacturing process.
In order to establish and develop a future cooperation for new API sources we need several documents:
GMP Certificate of the manufacturer
Certificate of Analysis for three recent batches
Letter of access
Letter of engagement.
Statement for TSE/BSE risk
Specification of the products including in-house methods of analysis and validation of analysis methods,
Statement regarding the used solvents in manufacturing process and residual solvents according to General Chapter Residual Solvents in the USP 30 and General Texts Residual Solvents in the EP 6,
Stability studies in normal conditions, accelerated conditions and stress conditions.
Sample of 100 - 200 g for tests plus CoA.
Documents are compulsory for us in order to add or change the API source in our dossiers at Romanian National Drug Agency.