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Results For "Form-483"

117 News Found

Cipla incorporates JV company in USA
News | March 02, 2024

Cipla incorporates JV company in USA

Cipla completes transfer of Generics Business Undertaking


Briefs: Suven Pharmaceuticals, Remedium Lifecare and Kilitch Drugs India
News | February 24, 2024

Briefs: Suven Pharmaceuticals, Remedium Lifecare and Kilitch Drugs India

Suven Pharmaceuticals’ API and forumulations facilities complete USFDA inspection successfully


Briefs: Torrent Pharmaceuticals and Laurus Synthesis
News | December 17, 2023

Briefs: Torrent Pharmaceuticals and Laurus Synthesis

Laurus Synthesis receives Form 483 with 5 observations from USFDA


Briefs: GlaxoSmithKline Pharmaceuticals and Dr. Reddy's Laboratories
News | December 10, 2023

Briefs: GlaxoSmithKline Pharmaceuticals and Dr. Reddy's Laboratories

Dr. Reddy's Laboratories has been issued a Form 483 with three observations


USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva
News | December 02, 2023

USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva

The company has received Form 483 with three observations


Briefs: Aurobindo Pharma and Balaxi Pharmaceuticals
News | October 03, 2023

Briefs: Aurobindo Pharma and Balaxi Pharmaceuticals

Balaxi Healthcare Ecuador S.A.S. has become a Wholly Owned Subsidiary of the company


Briefs: Mankind Pharma and Sequent Scientific
News | September 26, 2023

Briefs: Mankind Pharma and Sequent Scientific

Mankind Pharma commences the commercial operations newly set-up plant in Udaipur


USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA
Drug Approval | September 21, 2023

USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA

InvaGen has received 5 inspectional observations in Form 483


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


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