by inpharmedia | Sep 9, 2023 | Blog, Product Development, Regulatory
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, Product Development, Regulatory
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, Product Development, Regulatory
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, Regulatory
QUVIVIQ ITEMDESCRIPTIONSPONSOR/HOLDERIDORSIA PHARMACEUTICALS LTDApplication No.#214985Application TypeNDAActive IngredientDaridorexantDosage FormTABLETRoute of AdministrationORALStrengthsEQ 25mg BaseIndication for UseTreatment of adult patients with insomnia,... 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 | Feb 3, 2023 | Guidances, Regulatory
US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The January month has around 06 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and...
