US FDA

भारत बायोटेक के कोवैक्सीन को अमेरिका में इमरजेंसी अप्रूवल नहीं, FDA ने खारिज किया एप्लीकेशन

एफडीए ने इस टीके के लिए अमेरिका में भारत बायोटेक की पार्टनर Ocugenको बायोलोजिक्स लाइसेंस

FDA publishes draft guidance on assessing adhesion with TDS and topical patches for ANDAs

Updated recommendations are provided for the statistical analysis of adhesion scores and results The FDA has published the draft guidance for industry entitled, ‘Assessing Adhesion with Transdermal Delivery Systems and

Claris announces receipt of EIR from US FDA

The US FDA had conducted audit at Claris’ manufacturing facility near Ahmedabad in May 2015 Sterile injectables company; Claris Lifesciences has announced that it has received the Establishment Inspection Report (EIR) for i

Lupin announces closure of US FDA audits for its Mandideep and Aurangabad facilities

The US FDA had conducted audits at Lupin’s Mandideep facility from February 8-19, 2016 and its Aurangabad facility from January 11-15, 2016 Lupin has announced that it has received Establishment Inspection Reports (EIR) for

Indoco Remedies receives US FDA nod for Goa manufacturing facility

The approval confirms the closure of inspection conducted in July 2015

Dr Reddy’s recalls 50k bottles of Ondansetron tabs in US

The ongoing recall was initiated on March 30, 2016

Pharma exports growth heading for a sharp decline: CRISIL Research

As game changes, companies need to redraw long-term strategies and focus on innovation

Pfizer signs definitive merger agreement with Anacor Pharmaceuticals

To acquire Anacor Pharmaceuticals for $5.2 billion Pfizer and Anacor Pharmaceuticals have entered into a definitive merger agreement under which Pfizer will acquire Anacor for $99.25 per Anacor share, in cash, for a total tra

Aurobindo Pharma gets US FDA nod for anaesthetic injection

The product is expected to be launched in the second quarter of 2016-17 fiscal, it added

Embracing quality as an opportunity

Concerned with declining pharma exports in the recent past, the Ministry of Commerce & Industry has tried to burnish the brand image of India's pharmaceutical sector

US FDA warns Sri Krishna Pharma, citing drug-data manipulation

Sri Krishna Pharmaceuticals, a supplier of paracetamol and other drugs to more than 60 countries, has been warned by the US Food and Drug Administration (FDA), which cited manipulation of its test results at a plant.

Alembic Pharma receives FDA observations for Panelav plant

The company, however, did not provide any details about the observations

Pharma sector likely to report good growth for Q4 of last fiscal

According to a report in Centrum Broking, the domestic pharma market will gain from price increase, volume growth and new product introduction The pharma sector is expected to report good growth for the fourth quarter of 2015

Sun Pharma receives US FDA approval for BromSite

First NSAID approved for prevention of ocular pain in patients undergoing cataract surgery

FDA approves Micra, the first leadless pacemaker to treat heart rhythm disorders

The self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart The US Food and Drug Administration has approved the first pacemaker that does not require the use of wired leads to provi

Glenmark receives US FDA approval for bendamustine hydrochloride injection

It is Glenmark’s first injectable approval in the US

Indoco Remedies receives USFDA nod for solid dosages plant I in Goa

The plant has a capacity to manufacture 2.2 billion tablets, 32 million bottles of liquid orals, 16 million tubes of creams and ointments and 60 million capsules of hard gelatin

‘We compete against world class producers from the US and Japan’

Neelikon has emerged as a prime manufacturer of high quality colourants for food colour, pharmaceutical colours, cosmetic colours, personal care colours and ink industries. The company management talks about its three decades

Lupin completes acquisition of GAVIS

The combined company will have a portfolio of over 120 in-market products, over 185 cumulative filings pending approval and a deep pipeline of products under development for the US

Ajanta Pharma gets US FDA nod for migraine pain relief drug

Ajanta Pharma USA is scheduled to launch the almotriptan malate tablets in the US shortly Ajanta Pharma has received final approval for its generic version of acute migraine pain relief drug almotriptan malate tablets from th

Zydus receives US FDA approval for Glyburide and Metformin Hcl tabs

The formulations manufacturing facility at Baddi will produce the drug for the US market

Aurobindo Pharma receives US FDA approval for Acetylcysteine injection

The product is likely to be launched in Q1 FY16-17

Sandoz, Macleods Pharma recall two drugs made in India

The US FDA Enforcement Report for the week of February 17 said that the class III voluntary recall is nationwide US drug firm Sandoz is recalling more than 270,000 bottles of hypertension tablets, manufactured by Hyderabad-ba

Lupin, Gavis to sell two drugs to G&W Labs

The companies have agreed to sell rights and assets for two generic drugs to New Jersey-based G&W Laboratories in order to settle charges that Indian firm’s proposed acquisition would likely be anti-competitive Home

Cadila Q3 net up 38 per cent at Rs 390 cr

Total income of the company rose to Rs 2,428 crore for the third quarter

Ipca Labs gets warning letter from US FDA for three plants

The manufacturing units are located at Ratlam, SEZ Indore and Piparia Drug firm Ipca Laboratories has received warning letter from the US health regulator for three facilities on which the regulator had earlier imposed a impo

DRL receives US FDA approval for treatment of acute migraine episodes

ZEMBRACESymTouch is available as a prefilled, ready-to-use, single-dose disposable autoinjector containing 3 mg of sumatriptan US Food and Drug Administration (US FDA) has approved Dr Reddy’s Laboratories (DRL’s)

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