by inpharmedia | Oct 21, 2023 | Blog
The FDA guidance discusses on quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. The guidance specifically discusses on: Approaches to...
by inpharmedia | Sep 9, 2023 | Blog
Any drug substance or drug product has to maintain the same quality, safety and efficacy throughout the lifecycle of a product. Generally, the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such... by inpharmedia | Aug 15, 2023 | Blog
Solvent – A substance, majorly liquid capable of dissolving or diluting other substances to form a solution. Generally, several solvents are used in the manufacturing of drug substance, excipients and drug products as a routine practice. The solvents are used to...
by inpharmedia | Jul 24, 2023 | Blog
Every product should have a sufficient level of quality to ensure its efficacy and safety. The impurities/degradation products are the ones that arise during different stages of synthesis, manufacture and storage. They should be controlled at certain level to maintain... by inpharmedia | Feb 3, 2023 | Approvals, Blog, Regulatory
The U.S Food and Drug Administration (USFDA) has approved 04 new drugs in the month of January. Out of the 04 approvals, 03 are NDA and 01 is BLA. LEQEMBI ITEMDESCRIPTIONNDA/BLA Number:761269Applicant/Holder:EISAI INCAPI:LecanemabDosage... by inpharmedia | Dec 19, 2021 | Blog
The Hatch-Waxman Act provides certain market exclusivities for new drug applicants based on two factors: Patent Non-patent The patent related exclusivities are part of the discussion and we will learn further in this article. PATENT EXCLUSIVITY & the ORANGE BOOK:...