Identification of Complex APIs in Generic Drugs

The Generic Drug User Fee Act (GDUFA) is a law designed to accelerate access to safe and effective generic drugs to the public, and reduce costs to industry. The law was revised in 2017 (GDUFA II) to expand the scope of FDA's communication with industry. Complex active pharmaceutical ingredients (APIs) are identified in the GDUFA II Letter of Commitment as one of the categories of complex generic drug products that are eligible for the enhanced pre-abbreviated new drug application (ANDA) programs for complex generic drug products.

The complex APIs contained in generic products are diverse and include peptides, polymeric compounds, mixtures of different molecules, particles or macromolecules, naturally sourced ingredients, etc. They are targeted to treat a variety of complex diseases and are therefore important for the development of modern drugs. It is necessary to identify complex APIs in generic drugs. This ensures that generic drugs meet the same high standards of quality and consistency as their branded counterparts, thereby ensuring patient safety and drug efficacy.

Our Services

In order to accelerate the development of generic drugs, it is necessary to establish the sameness of the APIs between the reference listed drug (RLD) and the proposed generic drug. In order to achieve this goal, Alfa Chemistry provides analytical techniques such as mass spectrometry (MS) and nuclear magnetic resonance (NMR) to characterize the specific properties of complex APIs in generic drugs. These properties include, but are not limited to, physicochemical properties and primary, secondary and higher order structural features.

• MS is a technique that can be used to determine the molecular weight and chemical composition of a compound. It works by ionizing a sample and then analyzing the mass-to-charge ratio of the resulting ions. This information can be used to identify the molecular structure of the compound, as well as any impurities that may be present.

• NMR is a technique that can be used to determine the molecular structure of a compound by analyzing its nuclear magnetic resonance spectrum. This information can be used to identify the type and position of atoms in the compound, as well as the presence of any impurities.

By offering these analytical techniques, Alfa Chemistry provides pharmaceutical companies with the information they need to ensure that the efficacy of their generic drugs is equivalent to the original drugs.

Our Advantages

• Customized analytical solutions: Alfa Chemistry is able to customize analytical solutions to meet the specific needs of our customers.
• Fast turnaround time: Alfa Chemistry's analytical services have a fast turnaround time, which is important for time-sensitive projects.
• Compliance with regulations: Alfa Chemistry understands the regulations and guidelines of the pharmaceutical industry and can provide testing and analysis services in line with these regulations.
• Confidentiality: Alfa Chemistry can guarantee that customer data and results are not compromised, which is important for sensitive projects or proprietary information.

At Alfa Chemistry, we are committed to providing customers with high-quality services and strive to exceed their expectations. If you want to know more about the service, please contact us immediately. Alfa Chemistry is always your project partner.

Our services are for research use only.