Page 21 - Usfda

Active pharmaceutical ingredients focus helps drug firms offset slowdown

Besides captive consumption, the company also supplies APIs to external customers across international markets

Alembic Pharma gets USFDA nod for neuropathic pain management drug

The approved product is therapeutically equivalent to the reference listed drug Lyrica Capsules

InvaGen Pharma gets USFDA approval for neuropathic pain management drug

Cipla said the approved product is a generic therapeutic equivalent version of Pfizer's Lyrica

Strides Bengaluru unit gets 'Voluntary Indicated Action' status from USFDA

The flagship facility in Bengaluru is the largest manufacturing facility for the company with capabilities to produce finished dosage products across multiple formats

Zydus Pharma gets USFDA nod to market attention-deficit hyperactivity drug

The final approval from the United States food and drug administration (USFDA) is to market Dextroamphetamine Saccharate

Dr Reddy's Laboratories unveils generic version of Allegra-D in US

Allegra-D 12 HR is a trademark of Aventisub II Inc

Caplin Labs gets USFDA nod for injection to prevent excessive blood loss

Caplin Steriles said it has developed and filed 11 ANDAs on its own and with partners, with 5 approvals so far

USFDA completes Chennai facility audit with zero observations: Natco Pharma

Shares of Natco Pharma were trading 0.35 per cent higher at Rs 529.95 apiece on BSE

Bird faeces on packages in United Breweries warehouse, says USFDA

None of the pest control records addressed the issue of birds

Glenmark receives final nod from USFDA for drug to treat chronic angina

Glenmark Pharmaceuticals Tuesday said it has received final nod from the US health regulator for its Ranolazine extended-release tablets used for treatment of chronic angina. Glenmark Pharmaceuticals Inc has been granted final approval by the United States Food & Drug Administration (USFDA) for Ranolazine extended-release tablets in the strengths of 500 mg and 1,000 mg, the company said in a statement. The product is a generic version of Gilead Sciences Inc's Ranexa extended-release tablets in the same strengths, it added. According to IQVIA sales data for the 12-month period ended May 2019, Ranexa extended-release tablets, 500 mg and 1,000 mg market (which includes brand and all available therapeutic equivalents) achieved annual sales of around USD 929 million, Glenmark said. The company's current portfolio consists of 158 products authorised for distribution in the US marketplace and 57 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it ...

USFDA issues 12 observations for three units of Biocon in Malaysia

The company, however, did not provide any details about the observations made by the US regulator

Strides Pharma Puducherry unit receives warning letter from USFDA

The drug firm, however, did not provide any details of the contents of the warning letter received from the regulator.

Dr Reddy's Laboratories, Cipla arm recall drugs from American market

The USFDA has classified both the recalls as a Class-II recall

Fresh approvals for generic hypertension drug opens room for Indian firms

Sources revealed that the firms that got approval planned to launch the product in the US at the earliest

USFDA drug approvals at all-time high; Indian firms get 35-40% of nods

The regulator has bettered last year's numbers with 971 approval actions this year

Teva migraine drug gets US FDA approval, bolstering turnaround plan

Ajovy injection seen generating $500 million in sales by 2022

USFDA approves Vidya Herbs' plant extract unit in Bengaluru

Apart from maufacturing herbal extracts and essential oils, the firm has also diversified into coffee production

More USFDA approvals do not mean better margins for Indian 'big pharma'

Indian pharma firms including their subsidiaries have received around 304 abbreviated new drug application approvals from the USFDA in 2017

Lupin receives USFDA approval to market cholesterol-lowering drug

The tablets are indicated for treatment of adult patients with hypertriglyceridemia

USFDA issues warning letter to Telangana unit of Vista Pharmaceuticals

The USFDA has issued a warning letter to the manufacturing facility of the city-based Vista Pharmaceuticals Ltd, for "significant violations" of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The US Food and Drug Administration (FDA) officials had visited the facility located at APIIC Industrial Estate, at Gopalapalli in Nalgonda district in Telangana, from September 19 to 23, 2016. "This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211," the FDA letter said. "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B)," it said. The letter was issued on July 5 and addressed to Dhananjaya Alli, Managing ...