We assist in Abbreviated New Drug Application (ANDA) filings with complete CMC documentation, bioequivalence support, and eCTD submission. apicule helps generic manufacturers streamline approvals and meet all FDA requirements for market entry of generic drug products.
IntroductionAn Abbreviated New Drug Application (ANDA) is the regulatory pathway for getting generic drugs approved by the U.S. FDA. Filing an ANDA is a strategic move that allows pharmaceutical companies...
