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Dr. Kathiresan Rajasekar appointed President – International Business, Gufic Biosciences
People | January 16, 2025

Dr. Kathiresan Rajasekar appointed President – International Business, Gufic Biosciences

With over 28 years of experience in the pharmaceutical industry, he is a seasoned Techno? Commercial professional and accomplished top management leader


USFDA will no longer allow for use of FD&C Red No. 3 in food and ingested drugs
Policy | January 16, 2025

USFDA will no longer allow for use of FD&C Red No. 3 in food and ingested drugs

The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats


Alembic announces USFDA final approval for Brexpiprazole Tablets
Drug Approval | January 16, 2025

Alembic announces USFDA final approval for Brexpiprazole Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets


Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP
Drug Approval | January 13, 2025

Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP

Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure


Apotex acquires US rights to PROVIGIL and NUVIGIL
News | January 13, 2025

Apotex acquires US rights to PROVIGIL and NUVIGIL

PROVIGIL and NUVIGIL are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy


USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI
Drug Approval | January 13, 2025

USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI

Biocon Biologics remains committed to global standards of quality and compliance


Merieux completes acquisition of Bureau Veritas' food testing activities in Canada and US
News | January 10, 2025

Merieux completes acquisition of Bureau Veritas' food testing activities in Canada and US

The transaction is part of a broader agreement with Bureau Veritas covering its worldwide food laboratory testing activities


Ayush onsite to enrich experience at Mahakumbh: Prataprao Jadhav
News | January 09, 2025

Ayush onsite to enrich experience at Mahakumbh: Prataprao Jadhav

Services like 24/7 Ayush Multi-OPD clinics, mobile healthcare units, free distribution of Ayush medicines, and yoga camps are there for all visitors


Elinzanetant meets all primary and secondary endpoints in Phase III study OASIS 4 for treatment of vasomotor symptoms caused by breast cancer treatments
Clinical Trials | January 09, 2025

Elinzanetant meets all primary and secondary endpoints in Phase III study OASIS 4 for treatment of vasomotor symptoms caused by breast cancer treatments

The study also met all secondary endpoints with a reduction in severity of VMS at weeks 4 and 12, a reduction in frequency of VMS at week 1 as well as improvements in sleep disturbances and menopause related quality of life


Lupin receives EIR from USFDA for Pithampur Unit-1 Facility with VAI Classification
Drug Approval | January 09, 2025

Lupin receives EIR from USFDA for Pithampur Unit-1 Facility with VAI Classification

The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024