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2034 News Found

Lupin announces completion of pharmacovigilance inspection by USFDA
Drug Approval | March 27, 2023

Lupin announces completion of pharmacovigilance inspection by USFDA

The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide


India ready to be voice of the global south in collaborative fight against TB: Dr. Mandaviya
Policy | March 27, 2023

India ready to be voice of the global south in collaborative fight against TB: Dr. Mandaviya

India has a pivotal role in eliminating TB


Zydus receives final approval from USFDA for Doxepin Hydrochloride Capsules USP, 150 mg
Drug Approval | March 25, 2023

Zydus receives final approval from USFDA for Doxepin Hydrochloride Capsules USP, 150 mg

Doxepin Hydrochloride capsule is indicated to treat mental/mood problems such as depression and anxiety


Zydus receives final approval from USFDA for Lubiprostone Capsules, 8 mcg and 24 mcg
Drug Approval | March 25, 2023

Zydus receives final approval from USFDA for Lubiprostone Capsules, 8 mcg and 24 mcg

Lubiprostone capsule is indicated to treat certain types of constipation (chronic idiopathic constipation and irritable bowel syndrome with constipation)


Lupin receives tentative approval from USFDA for Obeticholic Acid Tablets
Drug Approval | March 24, 2023

Lupin receives tentative approval from USFDA for Obeticholic Acid Tablets

Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of US $255 million in the US (IQVIA MAT December 2022).


Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets
Drug Approval | March 22, 2023

Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets

Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)


Lupin receives approval from USFDA for Brexpiprazole Tablets
Drug Approval | March 22, 2023

Lupin receives approval from USFDA for Brexpiprazole Tablets

Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)


PHARMAP 2023 to focus on pharmaceutical challenges and strategies
News | March 22, 2023

PHARMAP 2023 to focus on pharmaceutical challenges and strategies

The Congress gathers the whole value chain of the pharmaceutical industry on June, 12-13, 2023 in Switzerland


Caplin receives USFDA approval for Rocuronium Bromide Injection
Drug Approval | March 21, 2023

Caplin receives USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)


Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit
Drug Approval | March 19, 2023

Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit

The observations are procedural in nature