Changes in drug production sites may be related to changes in drug prescriptions, suppliers of raw and excipient materials, production processes, process parameters and batches, and other registration management matters, which is the most complicated of all change situations. This article discusses the technical risk considerations for the production site change of oral solid preparations […]

A generic drug is a drug that is consistent with the original drug (reference drug, RLD) in terms of dosage form, strength, route of administration, quality, curative effect, and use. Generics play a key role in the health care system, accounting for more than 50% of all prescriptions. Generic drugs are approved on the basis

The research and development of polymorphic forms of drugs has always been a research hotspot in the field of biopharmaceuticals. Different crystal states of drugs will have an important impact on drug solubility, dissolution rate, bioavailability and other aspects. It is also a key link in the quality and safety control of drug production. It