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As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&amp;C) Act and related Acts.

USFDA issues Form 483 with 3 three observations to Gland Pharma's Visakhapatnam unit

Zydus Lifesciences on Wednesday said it has received approval from the US health regulator to produce a generic prostate cancer treatment drug.&nbsp;The company has received tentative approval from the US Food and Drug Administration (USFDA) to manufacture Enzalutamide tablets (40 mg and 80 mg), the drug maker said in a regulatory filing.

Zydus Lifesciences gets USFDA nod to produce prostrate cancer drug 

Alembic Pharmaceuticals said it has received final approval from the US Food &amp; Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Betamethasone Valerate Foam.

Alembic Pharma gets US health regulator FDA's nod for scalp psoriasis treatment drug

Indoco Remedies Ltd has received final approval from the USFDA to market its generic Lofexidine tablets, used in opioid discontinuation treatment. The approval grants Indoco 180 days of Competitive Generic Therapy (CGT) exclusivity.

Indoco Remedies gets USFDA nod to market Lofexidine tablets with 180 days exclusivity

Granules India announced that its subsidiary, Granules Pharmaceuticals Inc, has received approval from the US FDA for a generic version of Glycopyrrolate Oral Solution, 1 mg/5 mL. This anticholinergic medication is indicated for pediatric patients aged 3 to 16 years with neurological conditions associated with drooling.

Granules India gets USFDA nod for generic Glycopyrrolate oral solution

The US Food and Drug Administration (USFDA) conducted inspection at the injectables manufacturing facility between April 15 and April 23, 2024, Zydus Lifesciences said in a regulatory filing.

USFDA classifies Zydus Lifesciences Jarod unit as 'official action indicated' 

According to the report, Dr Reddy's Laboratories is recalling drugs to treat insomnia and gout in the American market.

Dr Reddy's, Sun Pharma recall drugs in US market: USFDA

The tentative approval by the US Food &amp; Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Ivosidenib tablets of strength 250 mg, the company said in a regulatory filing.

Alembic Pharma gets tentative nod from USFDA for Ivosidenib tablets 

The tentative approval by the US Food and Drug Administration (USFDA) is for Azilsartan Medoxomil tablets of strengths 40 mg and 80 mg, Zydus Lifesciences said in a regulatory filing.

Zydus Lifesciences gets tentative approval from USFDA for BP lowering drug

The tentative approval by the US Food and Drug Administration (USFDA) is for Azilsartan Medoxomil and Chlorthalidone tablets of strengths 40 mg/12.5 mg and 40 mg/25 mg, Zydus Lifesciences said in a regulatory filing.

Zydus Lifesciences gets tentative nod from USFDA for blood pressure lowering drug

Indoco Remedies gets nod to market generic diabetes drug from USFDA

The drugmaker said its product is indicated for the treatment of patients with acromegaly and gastroenteropancreatic neuroendocrine tumours.

Cipla gets USFDA nod to market Lanreotide injection

Glenmark Pharma news:&nbsp;Glenmark Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic brimonidine tartrate and timolol maleate ophthalmic solution indicated in the treatment increased pressure in the eye caused by glaucoma or other conditions.

Glenmark gets USFDA nod for generic ophthalmic solution

In the warning letter to the company, US Food and Drug Administration said its investigators observed various violations at the finished pharmaceuticals plant located at Kothur Village in Telangana.&nbsp;The USFDA inspected the facility from October 9 to 18, 2023.

USFDA pulls up Natco Pharma for manufacturing lapses at Telangana plant

As per the latest Enforcement Report by the US Food and Drug Administration (USFDA), Lupin is recalling 26,352 bottles of Rifampin Capsules (300 mg), an antibiotic medication in the US market.

Lupin, Glenmark recall drugs in US market: USFDA

​Shivalik Rasayan share price:&nbsp;Shivalik Rasayan shares skyrocketed on Wednesday, April 10 despite United States Food and Drug Administration (US FDA) issuing seven observations for its API facility in Bharuch.

Shivalik Rasayan shares skyrocket 10% despite 7 observations from US FDA

Aurobindo Pharma share price:&nbsp;Aurobindo Pharma shares gained over two per cent to Rs 1,013.6 apiece on NSE, rising for the fifth session in a row, after the&nbsp;Hyderabad-headquartered drug maker received approval from the US FDA for its nasal spray. Aurobindo Pharma said the product would be launched in the first quarter of the fiscal year 2025.

Aurobindo Pharma shares gain after drug maker wins US regulator approval for nasal spray

Cipla share price NSE, BSE:&nbsp;Cipla shares looked almost prepared to register a fresh all-time high in a special session on Saturday, March 2, after the US drug regulator completed inspections at a facility of the Mumbai-headquartered pharma company's Chinese subsidiary, Cipla Jiangsu, with zero observations.&nbsp;

Cipla shares trade within inches of record high; check out latest triggers for drug maker

In a warning letter to the company's CEO and MD Nimish Chudgar, the US Food and Drug Administration (USFDA) has pointed out various manufacturing lapses at the Matoda-Sanand, Ahmedabad-based facility.

USFDA pulls up Intas Pharma for manufacturing lapses at Ahmedabad plant 

Eugia Pharma Specialities has received final approval from the US Food &amp; Drug Administration (USFDA) to manufacture and market Budesonide Inhalation Suspension, the Hyderabad-based drug firm said in a regulatory filing.

Aurobindo unit gets USFDA nod to market generic asthma medication 

usfda

As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&amp;C) Act and related Acts.

Zydus Lifesciences on Wednesday said it has received approval from the US health regulator to produce a generic prostate cancer treatment drug. The company has received tentative approval from the US Food and Drug Administration (USFDA) to manufacture Enzalutamide tablets (40 mg and 80 mg), the drug maker said in a regulatory filing.

Alembic Pharmaceuticals said it has received final approval from the US Food &amp; Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Betamethasone Valerate Foam.

Indoco Remedies Ltd has received final approval from the USFDA to market its generic Lofexidine tablets, used in opioid discontinuation treatment. The approval grants Indoco 180 days of Competitive Generic Therapy (CGT) exclusivity.

Granules India announced that its subsidiary, Granules Pharmaceuticals Inc, has received approval from the US FDA for a generic version of Glycopyrrolate Oral Solution, 1 mg/5 mL. This anticholinergic medication is indicated for pediatric patients aged 3 to 16 years with neurological conditions associated with drooling.

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USFDA News- Zee Business provides latest news on USFDA, USFDA news Today, Top News on USFDA, update on USFDA Stay updated with business news, breaking news headlines.

USFDA

USFDA issues Form 483 with 3 three observations to Gland Pharma's Visakhapatnam unit

Zydus Lifesciences gets USFDA nod to produce prostrate cancer drug

Alembic Pharma gets US health regulator FDA's nod for scalp psoriasis treatment drug

Indoco Remedies gets USFDA nod to market Lofexidine tablets with 180 days exclusivity

Granules India gets USFDA nod for generic Glycopyrrolate oral solution

USFDA classifies Zydus Lifesciences Jarod unit as 'official action indicated'

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Top News

Nestle India share gains over 10% in two sessions post Q4; should investors book profit?

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HCLTech share price nosedives 10% after Q4 results; should you buy the dip?

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