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United States Food and Drug Administration (USFDA)

Aurobindo Pharma arm gets warning letter from USFDA for formulations unit in Telangana

Aurobindo Pharma arm gets warning letter from USFDA for formulations unit in Telangana

Fri, Aug 16, 2024

Aurobindo Pharma Ltd's subsidiary Eugia Pharma Specialities Ltd has received a warning letter from the USFDA for its Telangana-based formulation manufacturing unit. This follows the unit's earlier classification as 'Official Action Indicated' (OAI). Despite this, the company assures there is no impact on current US market supplies and remains committed to improving compliance with FDA regulations.

Alembic gets USFDA nod for generic medication

Alembic gets USFDA nod for generic medication

Tue, Aug 13, 2024

Alembic Pharmaceuticals has received approval from the US Food and Drug Administration (USFDA) to market Dabigatran Etexilate Capsules (110 mg), a generic product for the prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. This product is therapeutically equivalent to Boehringer Ingelheim's Pradaxa Capsules. With this approval, Alembic now has a total of 211 ANDA approvals from the USFDA. Shares of Alembic Pharmaceuticals closed 3.17% lower at Rs 1,076 apiece on the BSE

SEBI issues warning letter to Aurobindo Pharma over US FDA audit

SEBI issues warning letter to Aurobindo Pharma over US FDA audit

Mon, Jun 27, 2022

The Securities and Exchange Board of India (SEBI) on Monday issued a warning letter to pharmaceutical manufacturing company Aurobindo Pharma. The warning letter has been issued for not sharing complete information related to the United States Food and Drug Administration (US FDA). Zee Business report.

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Rakesh Jhunjhunwala backed Jubilant Pharmova shares surge 13% on Monday; here is what is triggering the stock

Rakesh Jhunjhunwala backed Jubilant Pharmova shares surge 13% on Monday; here is what is triggering the stock

Mon, Mar 21, 2022

As per exchange filing of Jubilant Pharmova, “The company has received Abbreviated New Drug Application (ANDA) final approval for Doxepin Hydrochloride Capsules, 10 mg, 25mg, 50mg, 75mg, and 100mg, the generic version of Sinequan.”

Cipla recalls 4,800 bottles of anti-HIV tablets from US

Cipla recalls 4,800 bottles of anti-HIV tablets from US

Sun, Dec 30, 2018

As per the latest Enforcement Report by the United States Food and Drug Administration (USFDA), the reason for the recall of the bottles is 'failed dissolution specifications'.

FDA made nine observations post Halol unit inspection: Sun Pharma

FDA made nine observations post Halol unit inspection: Sun Pharma

Thu, Dec 08, 2016

The company did not disclose the observations made by the USFDA.

Jubilant Life Sciences gains 8.53% on USFDA drug approval

Jubilant Life Sciences gains 8.53% on USFDA drug approval

Mon, Oct 03, 2016

Jubilant Life Sciences rose over 8% on BSE during opening trade on Monday after the company received USFDA approval for its RUBY-FILL- Rubidium 82 Generator and elution system.

Sun, Dr Reddy's, Glenmark strengthen their US play

Sun, Dr Reddy's, Glenmark strengthen their US play

Mon, Jul 18, 2016

Domestic pharma players are in stiff competition in US market. Sun Pharma with its taking over of SPARC's ELEPSIA XR, while Dr. Reddy launching Omeprazole and Sodium bicarbonate capsules and that of Glenmark waiting for 62 ANDA's approval, plans to strenghthen their position in the US.

WATCH: Top 7 corporate news this afternoon; From Andhra Bank receiving board's nod to Apollo Hospitals partnering with Chinese company

WATCH: Top 7 corporate news this afternoon; From Andhra Bank receiving board's nod to Apollo Hospitals partnering with Chinese company

Tue, Jun 21, 2016

Zee Business brings you the most important stories of the day that will help you shape your market strategies and keep you informed with the latest developments. Today's top seven corporate news: 1. Andhra Bank's board okays raising Rs 1,000 crore via bonds

Natco Pharma surges nearly 9% as partner Mylan Inc gets USFDA nod

Natco Pharma surges nearly 9% as partner Mylan Inc gets USFDA nod

Fri, Jun 03, 2016

The company's stock soared 8.54% to settle at Rs 518.35 on the Bombay Stock Exchange (BSE).

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