Biometrik has successfully completed a bioequivalence study on Amlodipine products from 15 pharmaceutical industries, facilitated by the Ministry of Health
Writer : Mas Muhammad Luqman Imam Al – as’ari
Editor : Oktaviani Utami Dewi
The project of Change Source Local Raw Materials for Amlodipine Bioequivalence Study Facilitated by Ministry of Health has already completed. The project awarded to 15 Pharmaceutical industries i.e PT Imedco Djaja, PT Interbat, PT Ikapharmindo Putramas, PT Harsen Laboratories, PT Kimia Farma Tbk, PT Bernofarm, PT Ifars Pharmaceutical Laboratories, PT Konimex, PT Rama Emerald Multi Sukses, PT Sejahtera Lestari Farma, PT Combiphar, PT Novell Pharmaceutical Laboratories, PT Berlico Mulia Farma, PT Graha Farma, and PT Pratapa Nirmala. All of Amlodipine Bioequvalance Study for 15 Pharmaceutical industries have been finished on October 30th, 2023. It was earlier than the time planning with the successfully results of 100% Bioquivalence. The results of this study are valid and comply to the requirement of Regulation of Indonesian Food & Drug Regulatory Authority Number 11, for Bioequivalences Studies, 2022 and European Guidelines on The Investigation of Bioequivalence European Medicines Agency (EMA), 2010.
The great achievement of PT Biometrik Riset Indonesia in completing this project as the results from the dedication and commitment of all employees, good communication and teamwork, as well as support from all parties involved such as regulators, the ministry of health, and the pharmaceutical industries. This achievement is encourages and convincing the existence of PT Biometrik Riset Indonesia as a trusted and reputable CRO (Contract Research Organization) to continuous improvement to develop globally.
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