Usfda

Showing of 1 - 20 from 114 results
Usfda - Total results - 114
Glenmark Pharmaceuticals receives approval from USFDA to market generic drug for muscle pain in American market
Business

Glenmark Pharmaceuticals receives approval from USFDA to market generic drug for muscle pain in American market

Glenmark Pharmaceuticals on Wednesday said its subsidiary has received approval from the US health regulator to market Chlorzoxazone tablets, used to treat muscle pain, in the American market

Cipla submits application with USFDA for generic version of asthma drug
Business

Cipla submits application with USFDA for generic version of asthma drug

Drug major Cipla on Monday said it has submitted an application with the US health regulator for a generic version of GSK's Advair Diskus, which is used in the treatment of asthma and other respiratory disorders

Fitbit may soon make emergency ventilators to tackle COVID-19 crisis, says CEO James Park
News & Analysis

Fitbit may soon make emergency ventilators to tackle COVID-19 crisis, says CEO James Park

Fitbit Inc, which is known for making activity trackers, smartwatches and wireless-enabled wearable technology, will be shifting supply chain resources to make emergency ventilators.

India's Jubilant Life inks licensing agreement with Gilead to manufacture Remdesivir, a potential drug to treat COVID-19
Business

India's Jubilant Life inks licensing agreement with Gilead to manufacture Remdesivir, a potential drug to treat COVID-19

Jubilant Life Sciences Ltd on Tuesday said it has entered into a non-exclusive licensing agreement with Gilead Sciences, Inc that will grant it the right to register, manufacture and sell the latter's investigational drug, remdesivir

Lupin gets inspection closure report from USFDA for Pithampur manufacturing plant in Madhya Pradesh
Business

Lupin gets inspection closure report from USFDA for Pithampur manufacturing plant in Madhya Pradesh

Drug maker Lupin on Thursday said the US health regulator has closed the inspection of its manufacturing facility in Pithampur, Madhya Pradesh

Granules India gets approval from USFDA for selling Trospium Chloride extended-release capsules
India

Granules India gets approval from USFDA for selling Trospium Chloride extended-release capsules

Granules India has said that it has received a nod from the US Food and Drug Administration (USFDA) for marketing Trospium Chloride extended-release capsules.

Strides Pharma gets USFDA approval to sell Flucytosine capsules to treat rare fungal infection
India

Strides Pharma gets USFDA approval to sell Flucytosine capsules to treat rare fungal infection

India-based Strides Pharma has received approval from the United States Food and Drug Administration (USFDA) to market Flucytosine capsules

Zydus Cadila gets USFDA nod to market Baclofen tablets used to treat muscle spasm
India

Zydus Cadila gets USFDA nod to market Baclofen tablets used to treat muscle spasm

The tablets, which come in 5 mg, help relax the muscles. Baclofen tablets will be manufactured at Zydus Cadila’s facility in Baddi, Himachal Pradesh.

Biocon Biologics receives EIR from USFDA for two manufacturing facilities in Bengaluru
Business

Biocon Biologics receives EIR from USFDA for two manufacturing facilities in Bengaluru

Biocon Biologics India Ltd., a subsidiary of Biocon Ltd., said on Thursday it has received the Establishment Inspection Report (EIR) from the USFDA (the United States Food and Drug Administration) for the pre-approval inspection at two of its biologics manufacturing facilities in Bengaluru

Lupin's Mandideep Unit II facility in Madhya Pradesh receives EIR from USFDA
Business

Lupin's Mandideep Unit II facility in Madhya Pradesh receives EIR from USFDA

Pharma major Lupin on Wednesday said it has received an establishment inspection report (EIR) from the US health regulator for its Mandideep Unit II facility in Madhya Pradesh

Lupin gets EIR from USFDA for Nagpur plant; MD says committed to enhance compliance, quality standards at all sites
Business

Lupin gets EIR from USFDA for Nagpur plant; MD says committed to enhance compliance, quality standards at all sites

Drug maker Lupin on Monday said it has received an Establishment Inspection Report (EIR) from the US health regulator for its manufacturing plant in Nagpur

Coronavirus Outbreak: USFDA approves albuterol sulfate-based inhaler as demand increases due to COVID-19 pandemic
World

Coronavirus Outbreak: USFDA approves albuterol sulfate-based inhaler as demand increases due to COVID-19 pandemic

The generic version of the inhaler will be manufactured by Indian drugmaker Cipla Ltd.

Zydus Cadila gets USFDA approval to market generic schizophrenia drug Perphenazine
Business

Zydus Cadila gets USFDA approval to market generic schizophrenia drug Perphenazine

Zydus Cadila said it has 284 approvals and has so far filed over 386 abbreviated new drug applications (ANDAs) since the commencement of its filing process in the financial year 2003-2004.

Pharma major Lupin’s Aurangabad facility gets Establishment Inspection Report from USFDA
India

Pharma major Lupin’s Aurangabad facility gets Establishment Inspection Report from USFDA

Pharma major Lupin has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Aurangabad facility.

US Food and Drug Administration flags Sun Pharma's Halol plant, warns product approvals may be put on hold
Business

US Food and Drug Administration flags Sun Pharma's Halol plant, warns product approvals may be put on hold

Sun Pharmaceutical Industries seems to have suffered a setback as the US Food and Drug Administration (FDA) has placed its Halol plant under ‘official action indicated’.

Coronavirus outbreak: ICRA revises domestic pharma industry outlook to negative amid lockouts in parts of China
Business

Coronavirus outbreak: ICRA revises domestic pharma industry outlook to negative amid lockouts in parts of China

The domestic pharma industry is highly dependent on imports, with more than 60 percent of its active pharmaceutical ingredients (API) requirement being shipped from overseas locations, especially China.

Glenmark Pharmaceuticals gets USFDA's final nod for Deferasirox tablets; company shares trade higher
Business

Glenmark Pharmaceuticals gets USFDA's final nod for Deferasirox tablets; company shares trade higher

The tablet is used to treat high levels of iron in the body caused by multiple blood transfusions

Aurobindo Pharma's net profit rises 4.6% at Rs 639.5 crore in Q2, revenues grow nearly 18%
Business

Aurobindo Pharma's net profit rises 4.6% at Rs 639.5 crore in Q2, revenues grow nearly 18%

Formulation revenues for the quarter posted a growth of 21.8% YoY to Rs 4,793.8 crore and accounted for 85.6% of total revenues.

Glenmark Pharmaceuticals shares plunge 10% to hit 52-week low on USFDA warning letter
Business

Glenmark Pharmaceuticals shares plunge 10% to hit 52-week low on USFDA warning letter

Shares of Glenmark Pharmaceuticals tumbled nearly 10 percent and hit its 52-week low level on the bourses on Monday after the company received a warning letter from the US health regulator for its Baddi facility in Himachal Pradesh

USFDA pulls up Emcure Pharma for violating manufacturing practice norms at Pune plant
Business

USFDA pulls up Emcure Pharma for violating manufacturing practice norms at Pune plant

Because Emcure Pharma failed to correct repeat violations, the USFDA strongly recommends engaging a consultant to assist the firm in meeting CGMP requirements, it said.