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Results For "US-FDA"

256 News Found

Briefs: Caplin Steriles, Zydus  and APL Healthcare
Drug Approval | September 20, 2023

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients


Briefs: NATCO Pharma, Strides Pharma and Aurobindo Pharma
News | September 08, 2023

Briefs: NATCO Pharma, Strides Pharma and Aurobindo Pharma

Strides Pharma Science Limited to acquire 100% in Strides Pharma Services Pvt Ltd.


Biocon acquires oral solid dosage manufacturing facility of Eywa Pharma for US$7.7 million
News | September 02, 2023

Biocon acquires oral solid dosage manufacturing facility of Eywa Pharma for US$7.7 million

The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year


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


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


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


Hikal posts Q1 FY 24 consolidated PAT at Rs. 6.92 Cr
News | August 09, 2023

Hikal posts Q1 FY 24 consolidated PAT at Rs. 6.92 Cr

US FDA approval is in line with de-risking strategy for additional API site to service our global customer base


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