REGULATORY AFFAIRS JAPAN

we offer competent support

STRONG PRESENCE IN THE JAPANESE MARKET

DCS PHARMA (until 2015 DOLDER PHARMA) has been providing APIs to Japan for many years. The requirements by Japanese Pharmaceutical Affairs Law (PAL) are high and demanding whereas compliance to PAL is presenting a challenge to foreign manufacturers.

KNOW-HOW, EXPERIENCE, NETWORK

Due to our experience and knowledge of the Japanese system, we can support and assist API manufacturers throughout their registration process of their APIs in Japan. We can suggest active pharmaceutical substances to our customers that comply with cGMP and conform to the current Japanese PAL.

AVAILABLE PRODUCTS

Oxaliplatin, 5-Fluorouracil, Neostigmine Methylsulphate and Lidocaine are only a few examples of APIs that are registered in Japan and are supplied through DCS PHARMA .