Abbreviated New Drug Application (ANDA) and Abbreviated New Drug Submission (ANDS)

Generic drugs are a low-cost, safe, and effective alternative to brand name drugs for consumers across the world. Similar to brand name drugs, before a generic drug can be sold in US or Canada Markets it must be approved by FDA in US or by PDD in Canada. To obtain such approvals, companies must submit an Abbreviated New Drug Application (ANDA) in US or an Abbreviated New Drug Submission (ANDA) in Canada. These applications don’t require preclinical and clinical data to demonstrate the safety and efficacy of the drug but focus instead on firmly establishing the bioequivalence between the generic and innovator (brand name) drug.

How We Can Help?

We offer consultancy services to help develop your submission according to the FDA and Health Canada requirements.

Our regulatory team will work with you to collect the necessary information, prepare the submission filings, and assist with meetings and discussions with the US and Canada regulatory bodies towards a successful outcome of your pharmaceutical application.

New Drug Application (NDA) and New Drug Submission (NDS)

Companies interested in launching a new pharmaceutical drug in US or Canada must first submit a New Drug Application (to the FDA in US) or a New Drug Submission (NDS) (to the Health Canada’s Pharmaceutical Drug Directorate (PDD)). These regulatory filings are meant to confirm and substantiate the pharmaceutical safety and efficacy of the drug before it reaches the market.

NDA and NDS submissions enclose a comprehensive overview of the drug including important information about its active ingredients, its pharmacokinetics and pharmacodynamics properties as well as details about how the drug is manufactured, processed, packaged, and labelled.