Ami Organics Ltd announced that its Unit II manufacturing facility in Ankleshwar, Gujarat, has been granted Good Manufacturing Practices (GMP) certification by Japan’s Pharmaceutical and Medical Devices Agency (PMDA). The announcement was made via an exchange filing on April 24, 2025.
The certified facility manufactures various intermediates used in Active Pharmaceutical Ingredients (APIs). This regulatory approval is a major milestone for the company, enabling it to expand its footprint in the Japanese pharmaceutical market and strengthen its positioning in other highly regulated geographies.
The PMDA certification confirms that Ami Organics’ manufacturing standards meet the stringent quality and safety norms required by Japanese authorities. It also reinforces the company’s global compliance framework and commitment to high manufacturing standards.
This recognition is expected to support the company’s strategic goal of becoming a trusted partner for global pharmaceutical companies seeking high-quality API intermediates from India.
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