Active Pharmaceutical Ingredients
The Active Pharmaceutical Ingredient (API) portfolio is a core Strategic Business Unit. High quality standards and transparency in the manufacturing process make Unichem one of the most quality driven API manufacturing companies in the world.
Unichem offers a broad portfolio of APIs across various therapeutic areas. A strategic focus on new and complex APIs has led to more than 70 USDMFs (Drug Master Files) and 30 CEPs (Certificates of Suitability) being filed. Three state-of-the-art manufacturing sites across India provide a collective capacity of almost 600 KL.
The Active Pharmaceutical Ingredient (API) business requires strong infrastructure, technological expertise, experience and capability to carry out contract manufacturing and custom synthesis. Unichem provides customers a complete solution for API development, starting from samples and trial quantities to regulatory assistance required for registration and regulatory compliance.
The company’s facilities are designed to meet the highest global standards for API development with a focus on complex APIs, controlled substances and APIs for regulated markets, all of which are key to achieving Unichem’s strategic goals.