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R&D

505(b)(2)NDA

There are 3 major pathways when applying for drug permit review in the US, namely: 505(b)(1) NDA, 505(b)(2) NDA and 505(j) . New drug application (NDA) can be divided into 10 major classifications as indicated in the following table according to the properties of the drugs application.
Type 1 is New Molecular Entity (505(b)(1)), while the others are mostly within the scope of 505(b)(2) new drugs.

      • Leverage Handa’s drug delivery expertise to develop products that bring therapeutic value to patients.
      • Create intellectual property for future growth.
      • Brand line extensions, specialty pharmaceutical alternatives.

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