Dear Sir or Madam ,
Hope this email find you well ,
We are Biopharm for Scientific research and pharmaceutical Manufacturing Co. Located in 6th October city , Egypt . Kindly find attached the list of the APIs that we intend to procure in 2012 along with the quantities needed and specs. Many of these products are registered, while some are about to be registered but we have approval to produce pilot batches for bioequivalence.
Please review the list and respond by sending back the list and filling the last column indicating present or future availability of the APIs and date it is expected to become available. Include in the column next to it the price based on the stated quantity. Kindly send back the completed form to us for evaluation. Please note that the APIs must be included in the annex of your GMP certification or expected to be added to it. Kindly indicate so in a separate column next to the price.
Please note that for many dosage forms a bioequivalence study may be required by MOH, so please indicate if your API has undergone a similarity factor study vs the innovator or not.
We are ready to immediately order many of the products on the list upon receiving the above, then requesting a sample for analysis by QC. When we order a product it is expected that the technical data in the open part of the DMF to be sent as it is a requirement to register our products in neighboring countries.
In addition to completing the attached form, kindly send us your GMP certificate and CoA for the products you can quote. In addition, please send an updated product list for your APIs as well as any suggestion you may have for us to consider new products to register that are either on your existing list or in your pipeline. This will give us a head start in registering these products in a timely fashion.
Once your product is analyzed in our QC labs and found conforming we intend to register you as an approved supplier.
I look forward to your response at your earliest convenience.
Best regards,
MOhamed Hassan