Zydus receives final approval from the USFDA for Loperamide Hydrochloride Capsules USP, 2 mg

Zydus receives final approval from the USFDA for Loperamide Hydrochloride Capsules USP, 2 mg

Loperamide hydrochloride capsule is indicated for the control and symptomatic relief of acute nonspecific diarrhea and chronic diarrhea associated with inflammatory bowel disease.

FPJ Web DeskUpdated: Tuesday, March 28, 2023, 05:29 PM IST
article-image
Zydus receives final approval from the USFDA for Loperamide Hydrochloride Capsules USP, 2 mg | Image: Zydus (Representative)

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereinafter referred to as “Zydus”) has received final approval for Loperamide Hydrochloride Capsules USP, 2 mg (USRLD: Imodium Capsules) from the United States Food and Drug Administration (USFDA).

Loperamide hydrochloride capsule is indicated for the control and symptomatic relief of acute nonspecific diarrhea and chronic diarrhea associated with inflammatory bowel disease. The drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad (India).

Loperamide Hydrochloride Capsules USP, 2 mg had annual sales of USD 34.7 mn in the United States (IQVIA MAT, January 2023).

The group now has 356 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.

RECENT STORIES

OpenAI 'Chat GPT's Rival 'Claud AI' Debuts Their App On Android: Know All About The Features

OpenAI 'Chat GPT's Rival 'Claud AI' Debuts Their App On Android: Know All About The Features

'Bill Will Drive Away Companies, Stifle Startups': NASSCOM Seeks Urgent Meeting With Karnataka Govt...

'Bill Will Drive Away Companies, Stifle Startups': NASSCOM Seeks Urgent Meeting With Karnataka Govt...

Warner Bros. Discovery Plans Layoffs Targeting Nearly 1,000 Employees Amid Ongoing Industry...

Warner Bros. Discovery Plans Layoffs Targeting Nearly 1,000 Employees Amid Ongoing Industry...

Chidambaram's 'Dream Budget': Netizens React with Divided Opinions on Tax Reforms and Modi's...

Chidambaram's 'Dream Budget': Netizens React with Divided Opinions on Tax Reforms and Modi's...

Gujarat CM Bhupendra Patel Approves ₹1,740 Crore To Strengthen Road Infrastructure In State's...

Gujarat CM Bhupendra Patel Approves ₹1,740 Crore To Strengthen Road Infrastructure In State's...