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7113 News Found

Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03%
Drug Approval | August 17, 2023

Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03%

Glenmark's current portfolio consists of 184 products authorized for distribution in the U.S. marketplace


Lupin Launches Tiotropium Dry Powder for Inhaler for COPD in US
News | August 17, 2023

Lupin Launches Tiotropium Dry Powder for Inhaler for COPD in US

Lupin actively contributes to alleviating the burden of COPD for patients across the nation


Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations
Drug Approval | August 16, 2023

Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.


Lupin gets USFDA approval for Doxycycline Hyclate Delayed-Release Tablets USP
Drug Approval | August 16, 2023

Lupin gets USFDA approval for Doxycycline Hyclate Delayed-Release Tablets USP

Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023).


Pfizer receives USFDA approval for Elrexfio for the treatment of relapsed or refractory multiple myeloma
Drug Approval | August 16, 2023

Pfizer receives USFDA approval for Elrexfio for the treatment of relapsed or refractory multiple myeloma

ELREXFIO’s label contains a boxed warning for cytokine release syndrome and neurologic toxicity


Eugia Pharma receives USFDA Approval for Icatibant Injection
Drug Approval | August 16, 2023

Eugia Pharma receives USFDA Approval for Icatibant Injection

This is the 166th ANDA out of Eugia Pharma Speciality Group facilities


Dimensionless Technologies launches AushadhAI to support pharma supply chain
Digitisation | August 12, 2023

Dimensionless Technologies launches AushadhAI to support pharma supply chain

AushadhAI is purposefully designed to deliver significant advantages to the pharmaceutical supply chain's key constituents


Lupin receives USFDA approval for fluocinolone acetonide body oil
Drug Approval | August 09, 2023

Lupin receives USFDA approval for fluocinolone acetonide body oil

Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023)


USFDA completes PAD E inspection of Marksans' Goa facility
Drug Approval | August 09, 2023

USFDA completes PAD E inspection of Marksans' Goa facility

The inspection was conducted at its Goa, Vema manufacturing facility