Entering a new stage of high-quality development! Looking at the Current Situation and Tomorrow of the Pharmaceutical Excipients Industry

In March 2023, the WHO released a new draft of the "GMP for Pharmaceutical Excipients (QAS/23.921)", which provides detailed requirements for GMP standards in the production process of pharmaceutical excipients, including quality management, complaint recall and return, quality audit, cleaning and hygiene, document recording, equipment and facilities, verification and confirmation, and production management.

Pharmaceutical excipients can be divided into four categories based on their functions and uses. The excipients of the injection are antioxidants, co solvents, and isotonic modulators; The excipients for oral solid preparations include lubricants, fillers, adhesives, and diluents; The excipients for oral liquid formulations include dispersants, stabilizers, and suspension aids; The excipients for external use include anti adhesive agents, flavor correction agents, and projectiles.

The high-quality development of pharmaceutical excipients requires sound infrastructure, high-quality supporting industries, good production management, strong innovation driving force, and an excellent professional and technical talent team. With the development of globalization, China has become a key region for the global pharmaceutical industry transfer due to its cost advantage, sufficient technical personnel, rich production experience, and huge market potential, which will inevitably drive the growth of the pharmaceutical excipient market. Enterprises producing high value-added pharmaceutical excipients, especially new types of pharmaceutical excipient products, can obtain high market share and high profits with advantages in scale, product, quality, technology, and other aspects.

Looking forward to the future, professional pharmaceutical excipients will gradually replace non professional pharmaceutical excipients, and develop towards "production specialization, variety serialization, scientific application, and high-quality service". In addition, composite excipients will also be one of the development directions for pharmaceutical excipient products.