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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. ______ 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 author .....

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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 product and the inputs sought thereof in their application in AayaatNiryaat Form (ANF 4 E) are as per ANDA / DMF. I have also examined the proper norms of consumption and after technical scrutiny of relevant designs and drawings of the export produc .....

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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 or Adhoc Norms* * State NIL in case the SION or the adhoc norm 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 .....

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