Licensing
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Enaltec has successfully received 4 ANDA (Abbreviated New Drug Application) approvals from USFDA which are commercialised in US market. We are also expecting 1 more ANDA approvals by end of June 2022. These products are available for out-licensing in non-US markets and tailor fit dossiers can be provided for respective markets.
Apart from above, Enaltec has 75+ FDF dossiers which are readily available for technology transfer. These dossiers are available for regulated markets like Europe and fully comply with eCTD requirements.