The National Health Regulatory Authority (NHRA) of Bahrain, has issued a license to the Gulf Biotech Company (GBC) to manufacture the first injectable drug in the Kingdom.
The manufacturing facility has obtained the rights to produce the initial batches of injectable drugs after submitting studies for the products produced and confirming successful stability analyzes for them.
Injectable medicines will also be subjected to a final inspection before receiving Good Manufacturing Practices (GMP) certification, which will allow to begin manufacturing and marketing sterile and injectable formulations.
“The factory was licensed after meeting the conditions related to security, safety and quality in accordance with international standards,” said Dr. Mariam Al Jalahma, CEO of the authority.
The licensed factory will manufacture a variety of injectable human healthcare formulations such as vials, ampoules and prefilled syringes using the highest and best German technology from BOSCH.
Gulf Biotechnology is headquartered in the Bahrain International Investment Park (BIIP) in the Hidd Industrial Area and consists of three floors covering approximately 4,500 square meters.
Dr. Riyadh Al Ashban, CEO of GBC, “This cutting-edge technology guarantees complete technical work without human intervention.” The plant is expected to start production in the first phase of 56 basic pharmaceutical products in 2022, added Mr. Al Ashban.
NHRA was established in line with the kingdom’s Economic Vision 2030 to provide a clear direction for the continued development of its economy and the need for the regulation of the whole healthcare system. The regulatory procedures related to licensing health care facilities include hospitals, medical centers, private clinics, centers for allied health professionals, and pharmaceutical centers.