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Impurities – Classification, Thresholds Limits, Specification with RTR Considerations in APIs and Finished Products

Impurities – Classification, Thresholds Limits, Specification with RTR Considerations in APIs and Finished Products

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 the required quality of the drug substance/product. The potential impurities are most likely to arise during the synthesis of drug substance, purification, manufacturing and storage of the drug substance/drug product. The...

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FDA Novel Drug Approvals in January 2022

QUVIVIQ ITEMDESCRIPTIONSPONSOR/HOLDERIDORSIA PHARMACEUTICALS LTDApplication No.#214985Application TypeNDAActive IngredientDaridorexantDosage FormTABLETRoute of AdministrationORALStrengthsEQ 25mg BaseIndication for UseTreatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenanceApproval Date07/01/2022 CIBINQO ITEMDESCRIPTIONSPONSOR/HOLDERPFIZER INCApplication No.#213871Application TypeNDAActive IngredientAbrocitinibDosage FormTABLETRoute of...

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FDA Novel Drug Approvals in January 2023

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 Form:INJECTABLE/INJECTIONStrengths:500MG/5ML; 200MG/2MLIndications:Indicated for the treatment of Alzheimer’s diseaseApproval Date:06/01/2023 BRENZAVVY ITEMDESCRIPTIONNDA/BLA Number214373Applicant/HolderTHERAXOSBIO LLCAPIBexagliflozinDosage...

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US FDA Guidances Published in January 2023

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 reference.  1. M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms https://www.fda.gov/media/165049/download 2. Acromegaly: Developing Drugs for Treatment https://www.fda.gov/media/164858/download 3. Cannabis and...

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US FDA Guidances Published in December 2022

The US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The December month has around 04 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and reference. 1. Controlled Correspondence Related to Generic Drug Development https://www.fda.gov/media/109232/download 2. Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe...

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