Page 32 - Usfda

Strides Pharma Science may resume Ranitidine drug sale in US market

Strides' Ranitidine tablets 300 mg is within the acceptable limits for N-nitrosodimethylamine (NDMA) of 96 nanograms per day or 0.32 ppm

Cadila Healthcare dips 8% as USFDA issues warning letter for Moraiya plant

The company said the warning letter does not affect the existing business of the company in the US and the existing product supplies from the Moraiya facility will continue.

Ranitidine recall causes Rs 40-crore dent in Dr Reddy's provisioning

An amount of Rs 17 crore is recognised as a possible refund liability (as a reduction from revenue) arising out of the company's decision to recall the said product

USFDA issues warning letter for Cadila Healthcare's Moraiya facility

The formulation unit 45% of the firm's US sales; Cadila says letter does not impact its existing business in the United States for now

Lupin gets US health regulator nod to market hypothyroidism tablets

The product is a generic version of King Pharmaceuticals Research and Development LLC's Levoxyl tablets in same strengths, Lupin said

J&J's own expert working for FDA found asbestos in baby powder sample

(Reuters) - Ever since Johnson & Johnson disclosed this month that a government test had turned up asbestos in its Baby Powder, the company has attacked the validity of the result.

US FDA investigates heartburn drug Zantac as it may be carcinogenic

Zantac was once the top-selling drug in the world and has been in the market for 35 years

Alembic Pharma gets USFDA nod for ointment to treat various skin disease

Alembic said it has a cumulative total of 104 abbreviated new drug application (ANDA) approvals from USFDA

Indian pharmaceutical companies spread business to avoid regulatory ire

Increased USFDA import alerts could be reason for finding alternative sites

Lupin's ordeal with USFDA observations continues, shares slump over 10%

Anticipated increase in remediation and compliance costs, and possible delay in drug launches is pushing analysts to cut their forward estimates

Torrent Pharma rebounds 9% from day's low on heavy volumes

The US Food and Drug Administration (USFDA) has issued a warning letter to Torrent Pharma's Indrad (Gujarat) API and formulations facility.

FDA observations on Telangana plant a fresh headache for Aurobindo Pharma

The Telangana unit in question is an important one contributing about a fifth to US revenues

USFDA warning letter for Glenmark's Baddi unit, reason classified

The United States Food and Drug Administration (USFDA) had inspected the facility between April 15 and April 20 and earlier classified the inspection as an official action indicated

USFDA impact: DCGI asks states told to put antacids under scanner

The ranitidine market in India is roughly around Rs 700 crore, with about 180 brands

Dr Reddy's halts worldwide supply of Ranitidine drug after probe by USFDA

Ranitidine is an Over-The-Counter (OTC) and prescription drug which decreases the amount of acid created by the stomach

FDA experts recommend new drug to reduce sensitivity to peanut allergens

The recommendation all but assures the agency will approve the drug, called Palforzia and made by Aimmune Therapeutics

MDH sambhar masala taken off US shelves over salmonella contamination

The contaminated lot of MDH's sambhar powder was distributed in some northern Californian stores, US drug regulator said

USFDA pulls up Lantech Pharma for manufacturing violations at Andhra plant

The significant violations included the failure of the quality unit to ensure that quality-related complaints were investigated and resolved

Strides acquires USFDA approved manufacturing facility in Florida

Strides Pharma Science said the site has undergone several successful USFDA inspections and has no outstanding observations

Glenmark gets US health regulator nod for generic breast cancer injection

The product is a generic version of AstraZeneca Pharmaceuticals LP's Faslodex Injection in the same strength, the company said