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Results For "United-States"

1047 News Found

Unichem receives ANDA approval for Prasugrel Tablets
Drug Approval | August 31, 2023

Unichem receives ANDA approval for Prasugrel Tablets

Prasugrel tablets are indicated to reduce the rate of thrombotic CV events


Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules
Drug Approval | August 31, 2023

Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules

Topiramate is the generic version of Supernus Pharmaceuticals’ Trokendi XR


Lupin receives approval from USFDA for Pirfenidone Tablets
Drug Approval | August 28, 2023

Lupin receives approval from USFDA for Pirfenidone Tablets

This product will be manufactured at Lupin's Pithampur facility in India


Gland Pharma receives 2 observations under 483 for Pashamylaram facility
News | August 28, 2023

Gland Pharma receives 2 observations under 483 for Pashamylaram facility

The company is committed to address the observations and will submit its response to US FDA within the stipulated time


Zydus receives final approval from the USFDA for zinc sulfate injection pharmacy bulk package vials
Drug Approval | August 25, 2023

Zydus receives final approval from the USFDA for zinc sulfate injection pharmacy bulk package vials

Zinc Sulfate Injection is indicated in adult and paediatric patients as a source of zinc for parenteral nutrition


Briefs: J B Chemicals & Pharmaceuticals updates and Torrent Pharmaceuticals
Drug Approval | August 24, 2023

Briefs: J B Chemicals & Pharmaceuticals updates and Torrent Pharmaceuticals

The drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat


NIH and Exothera partner to produce GMP intranasal vaccine against SARS-CoV-2 for clinical phase I/II trial in Africa and US
News | August 24, 2023

NIH and Exothera partner to produce GMP intranasal vaccine against SARS-CoV-2 for clinical phase I/II trial in Africa and US

NIH’s candidate is based on the Adenovirus 4 backbone, largely used as a vector candidate in HIV and influenza vaccine clinical trials


Briefs: Concord Biotech, Cian Healthcare and Eris Lifesciences
News | August 23, 2023

Briefs: Concord Biotech, Cian Healthcare and Eris Lifesciences

Eris Lifesciences enters into term loan agreement with Citi Bank


Shiva Pharmachem files DRHP for its Rs. 900 crore IPO
News | August 22, 2023

Shiva Pharmachem files DRHP for its Rs. 900 crore IPO

The offer for sale comprises of up to Rs. 383 crore by Vishal Rakesh Agrawal, up to Rs. 383 crore by Rahul Rakesh Agrawal, and up to Rs. 134 crore by Geetganga Investment


Lupin receives approval from USFDA for Bromfenac Ophthalmic
News | August 20, 2023

Lupin receives approval from USFDA for Bromfenac Ophthalmic

Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT June 2023).