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FORMAT OF CHARTERED ENGINEER (CHEMICAL) CERTIFICATE

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..... mical) with Registration No. ______ dated ______. This Certificate is being furnished as per the requirement of paragraph 4.18 of Handbook of Procedures. 2. I hereby certify that the approval communication dated ______ of the Food Drug Administration / concerned regulatory authority of the country of import _________(name of country) pertains to the Drug Master File (DMF) reference No._______ .....

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..... on and after technical scrutiny of relevant designs and drawings of the export product, I hereby certify that they are correct in all respects and are actually required for the execution of the export product, for which the application is made. 4. I hereby certify the export product and the requirement of inputs thereof as follows: (a) Details of product(s) to be exported / supplied under th .....

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..... orm for the said export product is not available. 5. I am issuing this certificate having verified the approval of the concerned department / authority of the regulated overseas market and the details of each input and its quantity as given in ANDA / DMF of the applicant to that declared in the Aayaat Niryaat Form (ANF 4 E) and found them to be correct. 6. In the event that any of the statem .....

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..... wise provided for, solvent(s) shall be allowed maximum upto 25% of the requirement of solvents indicated in the ANDA / DMF for the purpose of advance authorisation. However, in cases where recovery is not possible and the solvent gets poisoned, full quantity of solvent as per ANDA / DMF shall be allowed. Chartered Engineer shall verify and certify the same accordingly for the details of solvents r .....

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