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FORMAT OF CHARTERED ENGINEER (CHEMICAL) CERTIFICATE

Appendix -4L - Procedure - Appendix - DGFT - Appendix -4L - APPENDIX- 4L (Please see paragraph 4.18 of HBP) (For Pharmaceutical Product manufactured through Non-Infringing process) 1. I am a Chartered Engineer (Chemical) with Registration No. ______ .....

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ity of the country of import _________(name of country) pertains to the Drug Master File (DMF) reference No.________, meant for the export product for which the advance authorisation application is being filed. 3. I have examined the details of requi .....

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ication (ANDA) / Drug Master File (DMF) of the applicant, as given at Sl. No. 2 above and as approved by the Food & Drug Administration / Concerned regulatory authority of the country of import. I have also verified that the details of the export .....

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t, 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: ( .....

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per ANDA / DMF of the applicant and that as per SION or Adhoc Norms*: Sl. No Input Description Technical Characteristics / Quality /Specification of the Inputs ITC (HS) Code Quantity (Along with the Unit of Measurement) Quantity allowed as per SION o .....

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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 statements / facts certified above by the undersigned, .....

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