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Results For "European"

924 News Found

EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer
Drug Approval | March 07, 2024

EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer

The validations confirm the completion of the applications and commence the scientific review process


Sakar's oncology unit receives EU GMP approval
Drug Approval | March 07, 2024

Sakar's oncology unit receives EU GMP approval

The WHO GMP approved vertically integrated ONCOLOGY unit of SAKAR has been selling products nationally since few quarters


Bayer strengthens pharma portfolio with new cardiology drug acoramidis
News | March 06, 2024

Bayer strengthens pharma portfolio with new cardiology drug acoramidis

Acquisition of exclusive commercialization rights for European markets


Briefs: SMS Pharmaceuticals and Vimta Labs
News | March 03, 2024

Briefs: SMS Pharmaceuticals and Vimta Labs

EDQM conducts GMP inspection of SMS Pharmaceuticals’ API facility


USFDA inspects Shilpa Medicare’s bio-analytical laboratory in Hyderabad
Drug Approval | March 02, 2024

USFDA inspects Shilpa Medicare’s bio-analytical laboratory in Hyderabad

This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently


Asahi Kasei offers pharmaceutical excipient Ceolus with nitrite concentration of 0.1 ppm or less
News | February 29, 2024

Asahi Kasei offers pharmaceutical excipient Ceolus with nitrite concentration of 0.1 ppm or less

Contributing to lower risk of potentially carcinogenic nitrosamine impurities in pharmaceuticals


Orchid Pharma's 'Exblifep' receives USFDA approval
Drug Approval | February 24, 2024

Orchid Pharma's 'Exblifep' receives USFDA approval

Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA


Spriya Lifescience Q3 FY24 PAT jumps 213% at Rs. 29.79 Cr
News | February 09, 2024

Spriya Lifescience Q3 FY24 PAT jumps 213% at Rs. 29.79 Cr

EBITDA for Q3 FY24 almost tripled to reach Rs. 41.49 crore


Qure.ai adds new FDA breakthrough device status for qSpot-TB
Digitisation | February 09, 2024

Qure.ai adds new FDA breakthrough device status for qSpot-TB

4 FDA clearances & 61 EU MDR CE tags achieved for AI in 18 months


Glenmark partners Pfizer to launch Abrocitinib in India
Drug Approval | February 01, 2024

Glenmark partners Pfizer to launch Abrocitinib in India

Developed by Pfizer, Abrocitinib has received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) in India