OBIGEN Pharma submitted its application to the Ministry of Economic Affairs (MOEA) on August 5, 2022, seeking accreditation as a biotechnology and pharmaceutical company. Following deliberation by the review committee on September 13, 2022, the application was approved.
After verification by the MOEA, OBIGEN Pharma was recognized as principally engaged in the research, development, and manufacturing of OBI-858, a novel botulinum toxin formulation. The company was found to meet the requirements stipulated under Article 4, Paragraph 1, Subparagraph 2 of the Biotechnology and New Pharmaceutical Industry Development Act and Article 2, Paragraph 1, Subparagraph 1 of the Regulations for the Accreditation of Biotechnology and Pharmaceutical Companies.
OBIGEN Pharma received the official approval document on September 23, 2022, and formally obtained its status as an accredited biotechnology and pharmaceutical company on September 24, 2022. The accreditation certificate is valid for five years, during which the company must continue to comply with the applicable requirements set forth in the Regulations for the Accreditation of Biotechnology and Pharmaceutical Companies.