Pei Li Pharmaceutical
A Boon to Generic Drug Development

Many generic drug companies today are struggling to deliver high-quality products at a competitive price. The reason: the inability to balance stringent compliance regulations and client requirements. To optimize clinical outcomes and drive the bottom line, they need the support of specialized and experienced teams that can discover, develop, test, and manufacture new medicine quickly, using fewer resources. Catering to this need in the APAC region is Pei Li Pharmaceutical, a Taiwan-based firm that offers a wide range of contract manufacturing and contract development and manufacturing services to develop both solid and semisolid dosage forms. “We specialize in creating highly potent pharmaceutical products for poorly soluble compounds or highly potent active ingredients,” states Kuo Zong-Chang President of Pei Li pharmaceutical. Having a reliable team and a unique production line, Pei Li Pharmaceutical is currently Taiwan’s largest contract manufacturing organization (CMO) for highly potent pharmaceutical products with clients across Japan and other parts of the Asia-Pacific region.

Pei Li Pharmaceutical has continuously invested in R&D in the areas of high barrier generic drugs and healthcare products to become one of the most trustworthy partners for not only generic drug development firms but also various renowned medical institutions. Focused on continuous internal improvement, the company has remained competent to streamline clients’ drug development processes holistically. “Backed by a strong R&D team with ten years of experience in formulation design and bioequivalence relevant study, we can accelerate drug registration procedures,” says Zong-Chang. The team brings valuable contribution to relevant studies in the field of process and analysis development. It also expedites product release by easing knowledge sharing with the client and carrying out corresponding adjustments.

“To ensure a win-win situation for our clients and us, we allocate sizeable budget for higher threshold product development each year and improve our R&D pipeline consistently,” highlights Zong-Chang.

During project execution, the professional team of Pei Li Pharmaceutical closely works closely with clients and their teams across all the stages of drug development. This active participation reduces the friction in communication and knowledge transfer, which in turn, allows clients to develop products and achieve their strategic goals in time.

As the pharmaceutical industry is highly regulated by laws and regulations, it has strict requirements on the management of raw material source, manufacturing, and tracking of medicines, among other factors. Therefore, Pei Li Pharmaceutical needs to connect seamlessly with global pharmaceutical networks to meet the industry demands. To that end, it leverages SAP, which is an efficient digital tool to optimize production line process management and improve business decision making.

Pei Li Pharmaceutical will continue to remain in lockstep with the latest regulatory requirements to enhance the quality of general medicine as well as highly potent pharmaceutical products such as tablets, capsules, softgels, suppositories, ointments, and granules.

With such a well-rounded approach to drug development, Pei Li Pharmaceutical has emerged as the trusted, long-term partner in the market. In an instance, after making several failed attempts to launch a unique, orally disintegrating tablet (ODT) in the market, a drug company approached Pei Li Pharmaceutical. With the help of Pei Li Pharmaceutical’s R&D team, the client improved the manufacturing process and configured the various parameters to align with the project requirement. Eventually, the client went on to make huge gains with the product released into the market quickly.

In addition, Pei Li Pharmaceutical’s production base in Taiwan has a dedicated production facility for highly potent pharmaceutical products, which can prevent cross contamination between high potent products and general pharmaceutical products. Meanwhile, the company is introducing PPE with powered air-purifying respirator (PAPRs) to ensure employee health and safety. The company has successfully completed PIC/s GMP on-site inspection conducted by Taiwan FDA and Japan PMDA, making it GMP-compliant.