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USFDA pulls up Intas Pharma for manufacturing lapses at Ahmedabad plant

USFDA pulls up Intas Pharma for manufacturing lapses at Ahmedabad plant

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 different drugs due to manufacturing lapses

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.

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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.

Aurobindo Pharma arm gets USFDA nod for Plerixafor injection

Aurobindo Pharma arm gets USFDA nod for Plerixafor injection

Tue, Jul 25, 2023

The approval granted by the US Food & Drug Administration (USFDA) is to manufacture and market Plerixafor Injection of strengths 24 mg/1.2 mL (20 mg/mL), single-dose vial, Aurobindo Pharma said in a regulatory filing.

Lupin plant gets 10 observations from US regulator; shares under pressure

Lupin plant gets 10 observations from US regulator; shares under pressure

Fri, Mar 31, 2023

The US Food and Drug Administration (USFDA) inspected Lupin's Pithampur plant from March 21 to March 29, 2023, and ended the inspection by issuing a Form-483 with ten observations, the drugmaker said in a filing. Lupin shares have been a top loser in the pharma pack today.

Sun Pharma recalls over 34,000 bottles of generic drug in US amid manufacturing issues

Sun Pharma recalls over 34,000 bottles of generic drug in US amid manufacturing issues

Sun, Feb 12, 2023

Sun Pharma had produced the lot at its Halol-based manufacturing facility in Gujarat. The affected lot was later distributed in the market by its US-based unit.

Sun Pharma's Halol worries persist as US drug regulator pulls up pharma major for lapses

Sun Pharma's Halol worries persist as US drug regulator pulls up pharma major for lapses

Sun, Jan 15, 2023

In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products.

Glenmark Pharma gets USFDA nod for generic drug

Glenmark Pharma gets USFDA nod for generic drug

Mon, Dec 19, 2022

For the 12-month period ended October 2022, the Cardene capsules 20 mg and 30 mg achieved annual sales of approximately USD 10.9 million, the company said citing IQVIATM sales data.

Value Pick: Brokerages bullish on Alembic Pharma stock; up to 30% upside on back of new launches, steady growth potential

Value Pick: Brokerages bullish on Alembic Pharma stock; up to 30% upside on back of new launches, steady growth potential

Wed, Apr 13, 2022

On Tuesday, Alembic Pharma arm got US FDA final nod for Lidocaine & Prilocaine cream USP, which is used to cause numbness before medical procedures.

Zydus Cadila gets USFDA nod to market Pimavanserin tablets

Zydus Cadila gets USFDA nod to market Pimavanserin tablets

Wed, Dec 22, 2021

Drug firm Zydus Cadila on Wednesday said it has received approval from the US health regulator to market Pimavanserin tablets, used in the treatment of certain mental disorders, in the American market.

Cipla receives USFDA nod to market Lanreotide injection in American market

Cipla receives USFDA nod to market Lanreotide injection in American market

Sun, Dec 19, 2021

Drug major Cipla on Sunday said it has received approval from the US health regulator to market the Lanreotide injection, used for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors, in the American market

Alembic Pharmaceuticals' joint venture Aleor gets USFDA approval to market Mupirocin cream

Alembic Pharmaceuticals' joint venture Aleor gets USFDA approval to market Mupirocin cream

Wed, Nov 17, 2021

The approved abbreviated new drug application (ANDA) for Mupirocin cream is therapeutically equivalent to the reference listed drug product (RLD), Bactroban cream (2 per cent) of SmithKline Beecham (Cork) Ltd, Ireland, the company said.

Dr Reddy's gets FDA nod for generic Revlimid; Enjoys 180 days exclusivity

Dr Reddy's gets FDA nod for generic Revlimid; Enjoys 180 days exclusivity

Tue, Oct 19, 2021

Dr. Reddy's Laboratories Ltd. has announced the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide capsules, from the U.S. Food and Drug Administration (USFDA).

Drug makers Granules India, Jubilant Cadista recall products in US market, enforcement report of USFDA says

Drug makers Granules India, Jubilant Cadista recall products in US market, enforcement report of USFDA says

Sun, Sep 12, 2021

As per the latest Enforcement Report by US Food and Drug Administration (USFDA), the US-based unit of Granules India is recalling over 1.14 crore Naproxen Sodium tablets, a non-steroidal anti-inflammatory drug used to treat pain, menstrual cramps, inflammatory diseases such as rheumatoid arthritis, gout and fever

COVID-19: USFDA approved! Aurabeat launches anti-viral air purifier in India - Check price, features and more

COVID-19: USFDA approved! Aurabeat launches anti-viral air purifier in India - Check price, features and more

Tue, Aug 10, 2021

Hong Kong-based Aurabeat on Tuesday said it has launched its United States Food and Drug Administration (USFDA)-approved air purifier in India priced in the range of Rs 17,000 to Rs 74,000 for different models, used for SARS-COV-2 disinfection.

Lupin gets warning letter from USFDA for Somerset facility

Lupin gets warning letter from USFDA for Somerset facility

Sun, Jun 13, 2021

Drug firm Lupin on Sunday said it has received a warning letter from the US health regulator for its Somerset facility in the US. The United States Food and Drug Administration (USFDA) had inspected the company's Somerset, New Jersey, facility from September 10, 2020, to November 5, 2020, Lupin said in a regulatory filing

Strides Pharma Science receives EIR for Bengaluru facility from USFDA

Strides Pharma Science receives EIR for Bengaluru facility from USFDA

Mon, Mar 30, 2020

"The flagship facility in Bengaluru is the largest manufacturing facility for the company with capabilities to produce finished dosage formulation products across multiple dosage formats including tablet, capsules, ointments, creams and liquids," it added.

USFDA inspection at Aurobindo Pharma's Unit IV

USFDA inspection at Aurobindo Pharma's Unit IV

Fri, Feb 21, 2020

The Company received a communication that the inspection conducted by the US Food and Drug Administration (USFDA) at our aforesaid Unit IV, from November 4, 2019, to November 13, 2019, is still open and under review

Zydus receives tentative approval from USFDA for Tofacitinib tablets

Zydus receives tentative approval from USFDA for Tofacitinib tablets

Sat, Apr 06, 2019

Tofacitinib is used alone or with other medications to treat moderate to severe forms of rheumatoid arthritis, the company said in a BSE filing.

USFDA classifies Lupin's Somerset facility as 'Official Action Indicated'

USFDA classifies Lupin's Somerset facility as 'Official Action Indicated'

Sun, Mar 17, 2019

Drug major Lupin Saturday said it has been cautioned by the US health regulator that its Somerset (New Jersey) facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed.

Aurobindo Pharma to recall 80 lots of blood pressure medicine Valsartan in the U.S.

Aurobindo Pharma to recall 80 lots of blood pressure medicine Valsartan in the U.S.

Thu, Jan 03, 2019

The impurity N-Nitrosodiethylamine (NDEA) was detected in quantities above the acceptable limit in certain tablets containing valsartan, the FDA said.

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