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Any molecule is filing for ANDA purpose, what are the
dissolution requirements / specifications needed ?
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Answer Posted / bharadwaja
anda filing is done for generic drugs , for the requirements
of dissolution first refer to innovators dissolution studies
and later check the pharmacopeia of particular country in
which it is to be marketed and check the site of ogd to get
the details of the medium and apparatus to be used ...
| Is This Answer Correct ? | 9 Yes | 0 No |
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