Page 34 - Usfda

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 ...

Wockhardt gets USFDA nod for generic eye drops

The product will be manufactured at a USFDA approved contract manufacturing organisation

USFDA scrutiny of Indian pharma units up three-fold in 6 years

This has led to rise in warnings too; 55% of GMP warnings since 2012 issued to Indian, Chinese cos

US FDA sounds alert on quality issues in Indian pharma

Warning letters might increase as 190 facilities are expected to be inspected in the next 3 years

USFDA inspects Cadila Healthcare's Moraiya facility

The FDA Form 483 notifies the company's management of objectionable conditions

USFDA warns Resonance Labs of manufacturing norms violations

Violations include failure to have adequate cleaning procedures to prevent contamination of products

Would Washington's FDA Fix Cure the Patients or the Drug Industry?

A bill that would speed up approval for medications and medical devices shows how a major initiative can get traction

India seeks inputs from 200 countries for amending drugs and cosmetics act

Drug controller is rest assured that only recommendations will be taken and the will ensure that laws do not harm the medium and small players in India

Natco Pharma gets EIR from USFDA for Chennai facility

USFDA released a copy of EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when agency determines the inspection to be closed

Orchid gets final nod from USFDA for Parkinson's drug

Orchid Pharma stock was trading up 12.18% at Rs 41.90 during the afternoon trade on BSE

More inspections due to rising drug imports from India: USFDA

The federal agency had taken action against companies like Sun Pharma last year & earlier Ranbaxy among other Indian drug companies.