Government approval is required for the production of animal bio-pharmaceutical products. The Chinese Ministry of Agriculture has granted Skystar three government permits to produce the following products: Forage Additive Products, Additive and Mixed Forage Products, and Veterinary Medicine Products according to a national standard known as the Good Manufacturing Practice (“GMP”) standard.
A company must establish its facility according to GMP standards, including both the facility and the production process. After establishing such a facility, the company files an application to operate the facility with the PRC Ministry of Agriculture, which then sends a team of specialists to conduct an on-site inspection of the facility.
A company cannot start production at the facility until it receives approval from the Ministry of Agriculture to begin operations.