US DMF submissions (API)

The US is the top destination for Indian pharma exports of APIs and formulations. In 2019, Indian companies submitted 616 API DMFs to the FDA. Thus, India maintains bulk drug supply supremacy to the US. With such a huge success, it becomes essential for every student to learn the USDMF filing procedure in detail.

Category: Crash Courses
Duration : 90 minutes is the training duration, course would be accessible for 4 days from the date of taking admission

Learning objectives

The course is designed to understand types of USDMF, submission, various reviews conducted by the FDA and their outcomes, reference guidance, and interview questions on this topic.  

Eligibility

B.Pharm/M.Pharm/M.Sc/B.Sc/MBA/ PhD/ Working professionals from Pharma/Bio-tech industry [QC/QA/R & D/F & D/ ADL/ RA/ Patents/International business etc] & those aspiring to enhance their regulatory affairs knowledge.

Anyone willing to know this topic can enroll.

Syllabus

  • Section 1: US API DMF submissions & review
    • Types of DMF, submission, review, communication letters etc 90 minutes

Fees : 2478

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    Course Include :
  • Video
  • Audio
  • PPT
  • PDF
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