Seeking Entecavir USP47 for Iraq Registration – DMF Mandatory

We are currently sourcing 450 grams of Entecavir USP47 for delivery to Iraq. This API will be used for regulatory evaluation and pharmaceutical development.

The following regulatory and quality documentation is required:

• Certificate of Analysis (COA)

• Particle Size Distribution (PSD)

• Pharmacopeia reference number

• Microbial limit test results

• GMP certificate

• Manufacturing License

• Material Safety Data Sheet (MSDS)

• Drug Master File (DMF) – mandatory

Additionally, please confirm the availability of CEP (Certificate of Suitability) or US DMF for regulatory submission.