Drug Department asking for documents to be notarizerd. What does it means? How documents should be notarized?
Notary means a person authorized to perform certain legal formalities, especially to draw up or certify contracts, deeds, and other documents for... Read More
Amedment in Schedule-V of D&C Rules: Revise ‘free salicylic acid’ content in drugs containing aspirin [CDSCO]
Posted on17 Apr 2019
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The Union health ministry will soon amend Schedule-V of the Drugs and Cosmetics (D&C) Rules, 1945 to revise the limit of ‘free... Read More
Plenity, weight management drug, received USFDA approval
Gelesis, a biotechnology company developing first-in-class hydrogel therapeutics to treat obesity and other chronic diseases related to the gastrointestinal (GI) tract, announced... Read More
Roche to launch emicizumab (Hemlibra) in India for people with haemophilia A on World Haemophilia Day
Roche announced that emicizumab (Hemlibra) has been approved in India for haemophilia A with factor VIII inhibitors. It is indicated as a... Read More
Novartis’ Cosentyx received CFDA (Chainese) approval to treat adults with plaque psoriasis
Posted on03 Apr 2019
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Novartis, a global leader in immuno-dermatology and rheumatology, announced that the China Health Authority NMPA approved Cosentyx (secukinumab), the first-in-class interleukin-17A (IL-17A)... Read More
How forced degradation can be achieved?
Posted on01 Apr 2019
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Degradation can be achieved by exposing the drug, for extended period of time, to extremes of pH (HCl or NaOH solutions of... Read More
What is ANOVA method?
ANOVA – Analysis of Variance Statistical method Analysis of variance (ANOVA) is a statistical technique that is used to check if the means... Read More
What is a Stability-indicating assay method?
Posted on01 Apr 2019
Tagsanalytical method, Forced degradation, stability study, Stability-indicating assay method, stress testing
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A Stability-indicating assay method can be defined as “Validated quantitative analytical method that can detect the change with time in the chemical,... Read More
CDSCO rejects Cipla’s application for marketing US-based MannKind Corporation’s inhaled insulin, branded Afrezza; Local climical trial is compulsory
An expert panel of the Central Drugs Standard Control Organisation (CDSCO) has insisted that a local clinical trial should be compulsorily conducted... Read More
Check Your Competency in Data Integrity
Data Integrity refers to maintaining and assuring the accuracy and consistency of data over its entire product life-cycle. Over the last few years several, FDA... Read More