Page 14 - Usfda

Lupin gets USFDA establishment inspection report for Pithampur facility

Drug firm Lupin on Tuesday said it has received an Establishment Inspection Report from the US health regulator for its Pithampur Unit-2 manufacturing facility. The Establishment Inspection Report (EIR) was issued after the last inspection of the facility, which manufactures oral solids and ophthalmic dosage forms, conducted from March 21-29, 2023, the Mumbai-based drug maker said in a statement. The US Food and Drug Administration (FDA) issues an EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted scrutiny. The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). According to the the USFDA, a VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. "This is a significant milestone as we build back our reputation of being best-in-class in quality and compliance. We look forward to ne

Lupin gets USFDA approval for generic version of Cyanocobalamin nasal spray

Pharma major Lupin Ltd on Monday said it has received approval from the US health regulator for its generic version of Cyanocobalamin nasal spray. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Cyanocobalamin nasal spray of strength 500 mcg/spray (one spray per device), Lupin said in a statement. Cyanocobalamin nasal spray is used to maintain normal vitamin B12 blood levels in patients with pernicious anaemia. "This product will be manufactured at Lupin's Somerset facility in the US," the company added. Cyanocobalamin nasal spray had estimated annual sales of USD 69 million in the US, Lupin said, citing IQVIA MAT March 2023 data.

Lupin receives US regulator's approval for Cyanocobalamin nasal spray

The nasal spray manufactured by Lupin is a generic version of Nascobal nasal spray

USFDA observations in 2022 focus on ancillary infra, written procedures

45% observations in 2022 around unavailability of written procedures and facility maintenance, ancillary infrastructure

Facing higher scrutiny, IPA plans monthly meetings with members on quality

Data suggests that Indian sites received fewer OAIs in the first six months of 2023

USFDA emphasises on response over perfection in inspections: Sarah McMullen

McMullen stressed the importance of a robust quality system

Spiriva approval gives earnings visibility to Lupin; valuations expensive

Lupin's shares declined 4.5 per cent in Thursday's intra-day trade

Fewer Indian pharma plants get US FDA action notice in 2023, so far

6 per cent of inspections in first 6 months of CY23 resulted in OAI status

Zydus Lifesciences gets USFDA nod for generic acne-treating drug

Zydus Lifesciences on Monday said it has received final approval from the US health regulator for its generic antibiotic Minocycline Hydrochloride extended-release tablets used for treatment of moderate to severe acne. The approval granted by the US Food and Drug Administration (USFDA) is for Minocycline Hydrochloride extended-release tablets of strengths 55 mg, 65 mg, and 115 mg, Zydus Lifesciences said in a regulatory filing. The tablet is used for treatment of moderate to severe acne in people aged 12 years and above. The product will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, the company said.

Pharma major Lupin gets establishment inspection report from USFDA

Lupin Limited received an inspection classification of "No Action Indicated" (NAI) after the inspection, which was conducted between March 6 to March 10

Ipca shares drop nearly 3% after USFDA's 11 observations about MP facility

Company says it takes quality and compliance issues with 'utmost importance'

Zydus Lifesciences gets USFDA nod to mfg generic version of Varenicline

Zydus Lifesciences on Tuesday said it has received final approval from the US health regulator to manufacture and market the generic version of Varenicline tablets indicated to treat smoking addiction. The approval by the US Food and Drug Administration (USFDA) is for Varenicline tablets of strengths 0.5 mg and 1 mg, Zydus said in a regulatory filing. The product will be launched shortly. It will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India, it added. Varenicline tablets, 0.5 mg and 1 mg had annual sales of USD 501 million in the US, the company said citing IQVIA MAT March 2023 data.

Zydus receives final approval from USFDA for esomeprazole magnesium

Esomeprazole magnesium for delayed-release oral suspension, 20 mg and 40 mg had annual sales of $42 mn in the United States

US FDA to temporarily import Chinese cancer drug to ease shortage

Cisplatin, a generic drug available for decades in the US, has faced national shortage since February after an Indian pharmaceutical company temporarily halted production for the US market

USFDA inspections of Indian sites still below pre-Covid-19 levels

On an average Indian sites have had only a 9% share of total global inspections, analysts point out

Contaminated drugs: USFDA uncovers failures in India's pharma factories

The $50 billion sector is under the spotlight after a number of recent scandals linked to smaller, privately-held Indian companies, including the deaths of dozens of children in Gambia and Uzbekistan

Caplin Point rises 10% after arm gets USFDA nod for anti-inflammatory drug

So far this calendar year (CY23), shares of Caplin Point have declined 0.4 per cent, as against 1 per cent rise in the S&P BSE Sensex

USFDA puts on hold Sun Pharma trials on dermatological drug regimen

The US health regulator has directed Sun Pharma to stop trials of a dermatological drug with a 12 mg dose regimen as its usage could lead to blood clots. The drug major on Tuesday said it had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose in one of the long-term Open Label Extension (OLE) studies. As a result, the agency has placed the investigational new drug (IND) on partial clinical hold due to the potential for thrombotic events and is requiring that subjects currently on the 12 mg dose in the OLE studies discontinue that dose, it added. There have been no thrombotic events reported to date for the 8 mg dose and USFDA has not placed the 8 mg dose on hold, the drugmaker said in a regulatory filing. "We are taking immediate steps to transition the patients in the OLE studies to the 8 mg BID dose arm in the ongoing studies," Sun Pharmaceutical Industries stated. No ...

USFDA puts partial clinical hold on Sun Pharma's dermatological drug

USFDA put a partial clinical hold on its application for an experimental dermatological drug due to the potential of thrombotic events

Pharma firm Ipca Labs' plant gets 3 observations from US drugs regulator

The observations were followed by the USFDA inspection at the site from April 18 to April 26