Page 20 - Usfda

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

Regulatory worries, price erosion may pull down Dr Reddy's US revenues

Repeat observations for an approved facility are an indication of consistent regulatory challenges for the company, says an analyst with a foreign brokerage

Unichem Laboratories gets USFDA nod to market pain management drug

Unichem said the product will be commercialised from its Ghaziabad, Uttar Pradesh, plant

Alembic Pharma gets US health regulator nod for ophthalmic solution

The company said it now has a total of 86 ANDA approvals from the USFDA

Unichem gets USFDA approval for high blood pressure drug Chlorthalidone

Unichem said the product will be commercialised from its Ghaziabad plant

Natco Pharma's API facility near Hyderabad gets 6 USFDA observations

The company said that key points of the observations in Form 483 are the supplier and service provider agreements to be made more robust

Fund managers bet on pharma sector as pricing pressure in US is stabilising

The Indian pharma sector has many attractive opportunities before it, such as the growing adoption of generic drugs in developed markets

Lupin gets Establishment Inspection Report from FDA for Aurangabad facility

The facility was inspected by the US Food and Drug Administration