Apr 25, 2017 at 22:14 | Source: CNBC-TV18
CNBC-TV18 accessed the form 483 which includes the two observations. While the first observation says that the pharma major's Srikakulam lab records do not include a complete record of all data, the second reads that the Srikakulam site does not always maintain complete records.
Apr 25, 2017 at 14:36 | Source: PTI
The company has received "final approval from the United States Food and Drug Administration (USFDA) to market olmesartan medoxomil tablets in the strengths of 5 mg, 20 mg and 40 mg", Cadila Healthcare said in a filing to BSE. The drug is an anti-hypertensive and will be produced at the group's formulations manufacturing facility in Ahmedabad, it added.
Apr 25, 2017 at 13:54 | Source: Moneycontrol.com
Zydus Cadila has received final approval from the USFDA to market Olmesartan Medoxomil tablets in strength of 5 mg, 20 mg and 40 mg.
Apr 25, 2017 at 11:30 | Source: PTI
"The company has received abbreviated new drug application (ANDA) final approval for olmesartan medoxomil tablets, 5 mg, 20 mg, and 40 mg and olmesartan medoxomil with hydrochlorothiazide tablets 20/12.5mg, 40/12.5mg and 40/25mg," Alembic Pharmaceuticals said in a BSE filing today.
Apr 25, 2017 at 11:15 | Source: PTI
In a BSE filing, the company said it has received abbreviated new drug application (ANDA) final approval for olmesartan medoxomil tablets - 5 mg, 20 mg, and 40 mg.
Apr 25, 2017 at 11:05 | Source: Moneycontrol.com
This is second approval that company has received from the USFDA during the current financial year.
Apr 25, 2017 at 10:32 | Source: Moneycontrol.com
Alembic Pharmaceuticals has received final approvals from the USFDA for its ANDAs for Olmesartan Medoxomil tablets, 5 mg, 20 mg, 40mg and Olmesartan Medoxomil with Hydrochlorothiazide tablets 20/12.5 mg, 40/12.5 mg and 40/25mg.
Apr 22, 2017 at 15:19 | Source: PTI
Drug firm Divis Laboratories today said the US health regulator has issued a warning letter to the company for its Vishakhapatnam facility.
Apr 21, 2017 at 09:57 | Source: Moneycontrol.com
Dadra site is the biggest unit for the compay after Halol plant, for supplying drug in the United States.
Apr 19, 2017 at 15:31 | Source: Moneycontrol.com
Aurobindo Pharma on Wednesday said it has received a Form 483 with six observations from United States Food and Drug Administration (US FDA) for its Unit-III formulation facility located at Bachupally in Hyderabad.