The National Health Regulatory Authority (NHRA) has announced the licensing of the first injectable medicines manufacturing site in the Kingdom of Bahrain.

The Gulf Biotech Company, established in 2015 as part of a joint Bahraini-Saudi venture, will be granted a Good Manufacturing Practices (GMP) certificate to start producing and marketing sterile and injectable formulations subject to passing an NHRA inspection.

Commenting on the facility’s impending inspection, Her Excellency Dr Maryam Al Jalahma, CEO of the National Health Regulatory Authority, said: “The NHRA will ensure that the injectable medicines manufacturing site meets the necessary safety and quality standards in-line with pharmaceutical manufacturing best practices.”

The 4,500 square metre facility is the first-of-its-kind in the Middle East to manufacture injectable formulations – such as vials, ampules, and prefilled syringes. The facility will utilise BOSCH technology to create a fully automated production line which is expected to be operational later in 2022.

This is the second pharmaceutical manufacturing company to be licensed in the Kingdom. In 2019, the NHRA granted Bahrain Pharma a license to produce nutritional supplements. The facilities will prioritise the production of medications in high demand that other Gulf-based companies do not currently manufacture.

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