BrightGene starts from characteristic APIs and pharmaceutical intermediates. While expanding and strengthening the characteristic API industry, BrightGene continues to extend to the downstream preparation field, and runs through the entire industrial chain from "starting materials → highly difficult intermediates → characteristic APIs → preparations".

At present, BrightGene's API production quality system has met the GMP or cGMP standards of China, the European Union, the United States, Japan and South Korea, and its preparation production quality system has met the Chinese GMP standards.

BrightGene strictly controls the quality, adheres to the quality objective of "continuously and stably producing drugs that meet the requirements of the intended use and registration standards", regards ensuring the drug quality and patient medication safety as the company's eternal pursuit, continuously improves the product quality management level, and strengthens the quality management in the production process.

On the basis of strict compliance with national statutory standards, BrightGene also strictly controlled and improved some key quality indicators, formulated internal control standards for enterprises that are higher than the statutory standards, and the control requirements for export products are in line with or higher than the standards specified in the European Union and the United States Pharmacopoeia; The company emphasizes system assurance and process control to reduce the risks that may occur during non production; At the same time, there are stricter and higher requirements in production environment control, quality element management and other aspects to ensure the effectiveness and safety of drugs.