Generic Drug Substances (GDS) Overview

The Company’s core business and operational expertise since its inception have been as a service provider in the manufacturing of Generic Drug Substances. Neuland has earned the identity of a preferred and reliable API Supplier in the pharmaceutical industry primarily due to consistency in product quality, knowledge and ability to deal with niche chemistry and on-time delivery performance.

Over 100 APIs across 10 diverse therapeutic areas
950+ Drug Master Files (DMFs) filed worldwide
65 active US DMFs
Support for New Drug Applications (NDAs)
Commercial scale cGMP manufacturing
Strong regulatory track record with regulatory agencies around the world (FDA,EDQM, BfArM,EMA, PMDA, TGA, ANVISA and others )
3 USFDA and EU GMP compliant facilities with a collective capacity of 907 + KL

The Company’s strengths in synthetic chemistry, process development, controlled supply chain and project management approach, built into all our operations and product development programs makes Neuland an ideal API partner for generics.

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