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Crystal Formulation Services, Formulation Tailor-made for Your Molecules
22 Apr 2022
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This milestone further demonstrates Candoo's expertise in formulation and biopharmaceutics to achieve bioequivalence among different polymorphs and/or salts. For new chemical entities (NCE), it is useful to conduct bridging studies in late clinical stage where a more stable or favorable polymorph or salt is identified, or to show BE between clinical and commercial formulations as per regulatory requirements. For generics, this technique will help clients to speed up the development of first-to-file (Paragraph IV) products and get products launched sooner.
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_.webp "Technical Guideline for the Study of Polymorphism of Innovative Chemical Drugs by National Medical Products Administration (NMPA)")