which type of data need to file ANDA submission in USA ?
- 3 Answers
- 7666 Views
- I also Faced
- E-Mail Answers
Answers were Sorted based on User's Feedback
Answer / navinpatel
The 1984 Hatch-Waxman Act effectively extended the
Abbreviated New Drug Application (ANDA) processes that
existed for to all generic drugs. ANDA is filed for the
approval of Generic drug in US after the expiration of DATA
Exclusivity of innovator.
ANDAs do not contain clinical studies but are required to
contain information establishing bioequivalence to the
originator.
ANDA can be filed using the Para filing as below:
Para 1 – Drug has not been patented
Para 2 - Patent has already expired
Para 3 - Date on which the patent will expire and that the
generic drug will not go on the market until that date passes
Para 4 - Patent is not infringed or is invalid
Content of ANDA in ICH CTD format:
1. Application form
2. Table of contents
3. Basis for abbreviated new drug application submission
4. Conditions of use
5. Active ingredients
6. Route of administration, dosage form, and strength
7. Bioequivalence
8. Labeling
9. Chemistry, manufacturing, and controls
10.Samples
11.Patent information
ANDA submission with Para 4 certification will get 180 days
market exclusivity.
| Is This Answer Correct ? | 5 Yes | 0 No |
Answer / darose
information on drug substance- API (DMF)+ EXCIPIENTS
INFORMATION ON FINISHED PRODUCT, MANUFACTURING AND PACKAGING
(CMC)
INFORMATION ON DEVELOPMENT (R&D)
INFORMATION ON STABILITY OF FINISHED PODUCT
LABELING
| Is This Answer Correct ? | 3 Yes | 1 No |
what is the difference between BirdFlu and Common flu?
If calibration of 12 bowl dissolution apparatus does not meets single stage procedure, how can u proceed calibration?
What is the role of buffers in HPLC analysis
what is a difference between drug purity and drug potency?
What experience do you have in training?
What is the different between GMP & cGMP ?
What are your duties in your current position?
Do you think it is possible to rehabilitate?
Which types of deviations are followed in pharmaceuial API manufacturing industry?
How to preform dissolution profiling
Why 3 validation batches charge in stability ?is there any specific reason for 3 ?
why an employee go for medical representative instead of quality?
Pharmacy 
