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Results For "regulatory"

1224 News Found

Lupin Mandideep plant gets USFDA green signal
Drug Approval | November 01, 2023

Lupin Mandideep plant gets USFDA green signal

The inspection of the facility conducted from August 7 to August 11, 2023


USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent
Drug Approval | October 26, 2023

USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer


BASF Pharma Solutions introduces premium services to its VPAs digital services platform
Digitisation | October 25, 2023

BASF Pharma Solutions introduces premium services to its VPAs digital services platform

Additional premium services in RegXcellence will include access to BASF’s Product Carbon Footprint data and direct downloads of audit reports


Clariant launches new range of excipients to improve stability and solubility of APIs at CPHI Barcelona
News | October 19, 2023

Clariant launches new range of excipients to improve stability and solubility of APIs at CPHI Barcelona

New effective carrier systems for drug delivery in different dosage applications including oral, topical & parenteral


Shilpa Medicare Unit IV, Jadcherla has cleared TGA, Australia GMP inspection
Drug Approval | October 18, 2023

Shilpa Medicare Unit IV, Jadcherla has cleared TGA, Australia GMP inspection

This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years


Syngene Q2 FY23-24 revenue from operations up 18.5% to Rs 910 Cr
News | October 18, 2023

Syngene Q2 FY23-24 revenue from operations up 18.5% to Rs 910 Cr

Profit after tax (before exceptional items) up 23% to Rs 215 crores


Evonik and Shandong Vland Biotech form JV in China with focus on gut health products for animals
News | October 14, 2023

Evonik and Shandong Vland Biotech form JV in China with focus on gut health products for animals

Evonik China and Shandong Vland Biotech agreed to build a joint venture to expand their presence in gut health solutions products for farm animals globally


Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations
Drug Approval | October 14, 2023

Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations

The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally


Ichnos Sciences inks agreement with Astria Therapeutics for OX40 antagonist monoclonal antibody portfolio
News | October 13, 2023

Ichnos Sciences inks agreement with Astria Therapeutics for OX40 antagonist monoclonal antibody portfolio

Astria will assume full cost and responsibility for the global development and commercialization of the licensed therapeutic program for all indications


GlobalData predicts product cannibalization within electrophysiology ablation space
News | October 12, 2023

GlobalData predicts product cannibalization within electrophysiology ablation space

PFA technology is only marketed in Europe, and yet, it has been dominating the electrophysiology market by storm