U.S. Abbreviated New Drug Application (ANDA)

Background of U.S. Abbreviated New Drug Application (ANDA)

ANDA is an application for a U.S. generic drug approval for an existing approved or licensed drug. An ANDA contains data for review and possible approval of a generic drug product. They are not usually required to contain preclinical and clinical trial data to establish the efficacy and safety of the drug. However, generic drug applicants must scientifically demonstrate that their product is bioequivalent to the innovator/brand drug through some methods, such as measuring the time it takes for the generic drug to reach the bloodstream of healthy volunteers.

ANDAs are submitted to the FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which is responsible for reviewing and approving generic products. Once approved, applicants can manufacture and market generic products. These drugs, which are equivalent to the original drug in terms of quality, composition, dosage, route of administration, use, and performance, provide the American public with a safe, effective, and low-cost alternative.

About Us

Our company provides all the tools needed for a successful ANDS to help companies obtain generic drug approval in the United States.

ANDA regulatory approval is a complex process that requires significant time and effort on the part of manufacturers to comply with the FDA's ever-changing ANDA submission requirements. Therefore, it is necessary for manufacturers to work with regulatory experts from the product development stage to effectively manage the complicated approval process. Our company is a reliable and experienced regulatory partner for on-time submissions and approvals. Our team of experts has a clear understanding of ANDA's complex submission requirements. And we have the ability to provide you with expert procedural and technical guidance to put your generic products on the U.S. market in the shortest route and timeframe.

Our ANDA Services

We provide our clients with complete ANDA services, including label review, technology gap analysis, eCTD submission to the FDA, processing of controlled letters, pre-submission meetings, and all other assistance required for generic approval. Our services include:

• Analysis of the feasibility of ANDA registration of the product in the US based on US regulatory requirements
• Regulatory consulting during the product development and manufacturing stages to guide clients in complying with specific requirements, such as product development through QbD methodology and GDUFA program implementation.
• ANDA file checklist sharing
• Gap analysis and regulatory assessment of generated source data
• Pre-submission management activities such as facility identification, DUNS/FEI/ANDA application number requests, etc.
• Preparation, translation, review, and submission of ANDA registration materials in CTD format according to current FDA and Refuse to Receive (RTR) requirements
• Full tracking of the official drug registration review process and communication with the FDA for the ANDA approval
• Assisting clients in preparing additional/missing documents for RTR/GDUFA compliance
• Regulatory strategy and response preparation for inquiries, such as IRs, DRLs, or CRLs during the ANDA approval process
• cGMP audits and guidance to clients to complete corrections on time

ANDA Submission Process

Our Advantages

• Tailored regulatory strategies
• Complete support from product development to final approval
• Competitive price

If you need help or have a question, please feel free to contact us for more details.