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

USFDA issues Form 483 with 3 three observations to Gland Pharma...

Tue, Feb 25, 2025

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&C) Act and related Acts.

Zydus Lifesciences gets USFDA nod to produce prostrate cancer drug

Zydus Lifesciences gets USFDA nod to produce prostrate cancer dru...

Wed, Oct 02, 2024

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

Alembic Pharma gets US health regulator FDA's nod for scalp...

Mon, Aug 26, 2024

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

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

Indoco Remedies gets USFDA nod to market Lofexidine tablets with...

Wed, Aug 21, 2024

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 gets USFDA nod for generic Glycopyrrolate oral solution

Granules India gets USFDA nod for generic Glycopyrrolate oral sol...

Tue, Aug 20, 2024

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.

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

USFDA classifies Zydus Lifesciences Jarod unit as 'official...

Thu, Jul 18, 2024

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.

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

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

Thu, Jul 04, 2024

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

Alembic Pharma gets tentative nod from USFDA for Ivosidenib tablets

Alembic Pharma gets tentative nod from USFDA for Ivosidenib table...

Thu, Jul 04, 2024

The tentative approval by the US Food & 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.

Zydus Lifesciences gets tentative approval from USFDA for BP lowering drug

Zydus Lifesciences gets tentative approval from USFDA for BP lowe...

Thu, Jul 04, 2024

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 nod from USFDA for blood pressure lowering drug

Zydus Lifesciences gets tentative nod from USFDA for blood pressu...

Fri, Jun 14, 2024

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.

Indoco Remedies gets nod to market generic diabetes drug from USFDA

Indoco Remedies gets nod to market generic diabetes drug from USF...

Thu, Jun 06, 2024

Indoco Remedies on Thursday said it has received approval from the US health regulator to market a generic diabetes medication.

Cipla gets USFDA nod to market Lanreotide injection

Cipla gets USFDA nod to market Lanreotide injection

Wed, May 22, 2024

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

Glenmark gets USFDA nod for generic ophthalmic solution

Glenmark gets USFDA nod for generic ophthalmic solution

Fri, May 17, 2024

Glenmark Pharma news: 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.

USFDA pulls up Natco Pharma for manufacturing lapses at Telangana plant

USFDA pulls up Natco Pharma for manufacturing lapses at Telangana...

Sun, Apr 21, 2024

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. The USFDA inspected the facility from October 9 to 18, 2023.

Lupin, Glenmark recall drugs in US market: USFDA

Lupin, Glenmark recall drugs in US market: USFDA

Wed, Apr 10, 2024

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.

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

Shivalik Rasayan shares skyrocket 10% despite 7 observations from...

Wed, Apr 10, 2024

Shivalik Rasayan share price: 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.

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

Aurobindo Pharma shares gain after drug maker wins US regulator a...

Wed, Mar 20, 2024

Aurobindo Pharma share price: 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 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.

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

Cipla shares trade within inches of record high; check out latest...

Sat, Mar 02, 2024

Cipla share price NSE, BSE: 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.

USFDA pulls up Intas Pharma for manufacturing lapses at Ahmedabad plant

USFDA pulls up Intas Pharma for manufacturing lapses at Ahmedabad...

Sun, Dec 10, 2023

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.

Aurobindo unit gets USFDA nod to market generic asthma medication

Aurobindo unit gets USFDA nod to market generic asthma medication...

Thu, Nov 30, 2023

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

Aurobindo Pharma shares slip 3% as company's US arm recalls different drugs due to manufacturing lapses

Aurobindo Pharma shares slip 3% as company's US arm recalls...

Tue, Aug 22, 2023

The stock came under pressure after reports said that Aurobindo Pharma, along with Alembic Pharmaceuticals, is recalling different products in the US market due to manufacturing lapses.

Alembic, Aurobindo recall drugs in US market

Alembic, Aurobindo recall drugs in US market

Tue, Aug 22, 2023

As per the US health regulator's latest Enforcement Report, the US-based subsidiary of Alembic Pharmaceuticals is recalling 82,400 bottles of Tobramycin Ophthalmic Solution in the American market.

USFDA issues warning letter to Intas Pharma for Sanand plant

USFDA issues warning letter to Intas Pharma for Sanand plant

Sun, Aug 06, 2023

The US health regulator also pointed out the company's failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards.

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