Active Pharmaceutical Ingredients
Chemigran provides a comprehensive range of Active Pharmaceutical Ingredients (APIs) sourced from GMP-certified manufacturers worldwide.
Each API is supported by complete regulatory documentation, including Drug Master Files (DMFs), Certificates of Analysis (COA), and stability data.
Our quality assurance team ensures that every batch complies with international pharmacopeial standards and regulatory expectations.
These APIs are suitable for generic drug manufacturing, formulation development, clinical trial materials, and supply to regulated export markets markets.
Including US FDA Reference Listed Drugs (RLDs)
For US regulatory submissions, we supply FDA-designated Reference Listed Drugs (RLDs).
For EU and other regulated markets, we provide qualified comparator products sourced from EMA-authorized manufacturers.
These reference materials are used for bioequivalence studies, analytical method development and validation, and support ANDA and IMPD submissions, as well as quality control and regulatory compliance activities.
Complex Biological Products
Chemigran specializes in biological products manufactured using advanced biotechnology platforms.
Our portfolio includes biosimilars, monoclonal antibodies, vaccines, and recombinant proteins.
All biologics are produced under strict cGMP conditions and undergo comprehensive characterization and quality testing to ensure safety, consistency, and performance.
These products support a wide range of applications, including therapeutic treatments, biosimilar development, research and development activities, and clinical use.
Nutritional Supplements
Chemigran offers a wide range of high-quality dietary supplements, vitamins, minerals, and botanical extracts.
All products are manufactured to pharmaceutical-grade standards and undergo third-party testing to verify purity, potency, and quality.
We also provide custom formulation development and private labeling services to support diverse market needs.
These nutraceutical products are widely used in dietary supplements, functional foods, sports nutrition, and wellness-focused consumer products.
