Us Food And Drug Administration (usfda)

Gland Pharma gets USFDA nod for generic breast cancer drug

The company has received approval from the US Food and Drug Administration (USFDA) for Eribulin Mesylate Injection (0.5 mg/mL single dose vial), it said in a statement.

Zydus gets USFDA nod for antiviral drug used in HIV treatment

The company has received final approval from the US Food and Drug Administration (USFDA) for Darunavir Tablets, the company said in a statement.

USFDA pulls up Intas Pharma for manufacturing lapses at Ahmedabad plant

In a warning letter to the company's CEO and MD Nimish Chudgar, the US Food and Drug Administration (USFDA) has pointed out various manufacturing lapses at the Matoda-Sanand, Ahmedabad-based facility.

Jubilant Pharmova gets VAI status from USFDA for India facility, stock climbs

Jubilant Pharmova's shares settled at Rs 314 apiece at the BSE, which was Rs 9.85 or 3.24 percent higher as against the previous day's close.

No link between use of high-selling antacid ranitidine and cancer risk: Korean study

The molecule sold under the brand name of Zinetac and Rantac, among others in India, has been facing a controversy since 2019, after an unacceptable level of a probable carcinogen was found in its Active Pharmaceutical Ingredient.

Zydus gets USFDA nod for anti-cancer drug

Lenalidomide is used to treat various types of cancers. It works by slowing or stopping the growth of cancer cells

Aurobindo Pharma receives 'warning letter' from SEBI over USFDA audit row

Aurobindo Pharma "disclosed very limited and restricted information" about the warning it had received from the American drug regulator, SEBI said.

USFDA issues warning letter to USV Pvt over Daman plant

In a warning letter, the US Food and Drug Administration (USFDA) said the firm failed to establish laboratory controls designed to make sure components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity at its plant.

Tulsian says book profits in D-Mart around Rs 540-545; buy Kopran

We are giving a buy call on Kopran which is also looking quite good because of their research space and the kind of good financial performance the company has been posting, says SP Tulsian.

Strides Shasun gets USFDA tentative nod for HIV treatment drug

The company has received tentative approval from the US Food and Drug Administration (USFDA) for Efavirenz tablets USP, 600 mg, Strides Shasun said in a regulatory filing.

Alembic Pharma gets USFDA nod for seizures treatment drug

"The company has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lacosamide tablets, 50 mg, 100 mg, 150 mg and 200 mg," Alembic Pharmaceuticals said in a BSE filing.

USFDA actions hurting exports, need govt intervention: DrReddy's

Exports of pharma although grew by 9.7 per cent but it used to be in double digits in the past so it has come down slightly, Reddy said.

USFDA rejected 11,664 products since January 2011: Sitharaman

"According to refusal report data available on the US Food and Drug Administration (USFDA) website, 11,664 refusals of Indian products were recorded from January 2011 to February 2016," Minister of State for Commerce and Industry Nirmala Sitharaman today said in written reply to the Rajya Sabha.

Glenmark gets tentative nod from USFDA for azelaic acid gel

Glenmark will market this product upon receiving final approval, it said, adding that the patent for Finacea topical gel, 15 percent, is scheduled to expire on November 18, 2018.

Dr Reddy's gets tentative approval from USFDA for Zenavod

of chronic skin disease in adult patients. The approval by the US Food and Drug Administration (USFDA) for doxycycline capsules (Zenavod) is of strength 40 mg. Zenavod is a tetracycline-class drug indicated for treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients, the firm said in BSE filing today.

Aurobindo Pharma receives USFDA nod for generic drug

The company has received the final nod from the US Food and Drug Administration (USFDA) to manufacture and market Norethindrone Acetate tablets in the strength of 5 mg, Aurobindo Pharma said in a statement.

Dr Reddy's submits response to USFDA over warning letter

In response to the letter, DRL CEO G V Prasad had said the company is in the process of shifting some of the products from these plants to other facilities and considering third party assessment for its plants.

Strides Shasun gets USFDA nod to market Dutasteride tablets

The company has received approval from the US Food and Drug Administration (USFDA) to market Dutasteride capsules in the strength of 0.5 mg, Strides Shasun said in a regulatory filing.

Aurobindo gets USFDA final nod for anti-psychotic tablets

"The company has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Aripiprazole tablets... and the product is ready for launch," Aurobindo Pharma said in a statement on Friday.

USFDA denies approval to SPARC's epilepsy drug

The Mumbai-based drug major is working with USFDA in resolving the current good manufacturing practice(cGMP) deviations at the facility and has taken several corrective measures

Returns could take longer but buy on dips, says Nipun Mehta

For investing, one should look at getting into fundamentally sound stocks and sectors that have consistently performed but the wait could be longer, says Nipun Mehta of Blue Ocean Capital Advisors.

Cadila recalls 15,144 bottles of hypertension drug in US

The nationwide recall has been initiated by the company on October 1 this year and has been initiated under Class-III which FDA defined as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences".