Aarti Pharmalabs Limited (APL) engages in the development, manufacture and supply of Active Pharmaceutical Ingredients (API) and drug substances, with capabilities extending from early-stage New Chemical Entities (NCEs) through to commercial manufacture. Its operations include intermediates, Regulatory Starting Materials (RSM), key building blocks, basic starting materials, xanthine derivatives and API intermediates. The firm supports clients internationally and maintains a strong regulatory compliance track record through multiple accreditations. In addition to manufacturing, APL invests in process R&D, stability studies, scale-up, process optimisation, and process validation.

The company’s infrastructure comprises six manufacturing plants in India, backed by two R&D centres. Its facilities are accredited by several regulatory authorities, including USFDA, EU GMP, EDQM, KFDA, and COFEPRIS. APL emphasises environmental, health and safety standards, incorporating sustainability, innovation and operational excellence into its strategic framework.

Key Products and Services

• Development and manufacture of Active Pharmaceutical Ingredients (APIs) and drug substances, including New Chemical Entities.
• Production of API intermediates, key building blocks, Regulatory Starting Materials (RSM) and basic starting materials.
• Specialised xanthine derivatives, acid & allied chemical products.
• Contract development and manufacturing (CDMO) services, including technology transfer, scale-up, process optimisation and commercial GMP manufacturing.
• Analytical and stability services, process validation.
• Regulatory compliance and accreditation support.

With a long-standing regulatory pedigree exceeding fifteen years, Aarti Pharmalabs Limited positions itself as a reliable partner for pharmaceutical companies seeking end-to-end support in API and drug substance development. Its combination of robust R&D, accredited manufacturing capacity and emphasis on safety, quality and sustainability aims to deliver consistent supply and high standards to a global clientele.