The FDC is also effective in treating symptoms like watery eyes, runny nose, sneezing and other discomforts
Drug firms Glenmark Pharmaceuticals and FDC Ltd are recalling products in the US market due to manufacturing issues, according to the US Food and Drug Administration (USFDA). In its latest Enforcement Report, the US health regulator said a US-based subsidiary of Mumbai-headquartered Glenmark Pharmaceuticals is recalling a certain number of a generic hypertension medication in the US market. New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling Carvediol tablets in strengths of 25 mg and 12.5 mg in the US, the US health regulator stated. The company is recalling the product as "N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit". The company initiated the Class II recall on January 22 this year. USFDA said FDC Ltd is recalling 1,18,104 bottles of a medication for the treatment of glaucoma. The drug firm is recalling the affected lot of Timolol Maleate ophthalmic solution USP produced at its Aurangabad-based plant, it added
EBITDA for Q3FY25 was impacted by lower sales in export formulation biz, price reduction in the Electral range of products, driven by NLEM price revisions changes in the product mix, and higher cost.
The list of FDCs banned includes antibiotics, anti-allergics, painkillers, multivitamins, and combination doses for fever and hypertension, among others
Piramal Enterprises, KRBL, FDC and IndiaMART InterMESH turned ex-date for share buyback on Friday, falling in the range of 2 per cent to 4 per cent on the BSE in intra-day deals.
Since April, the stock price of FDC has appreciated 48 per cent as compared to 11.2 per cent rise in the S&P BSE Sensex
One of the key FDCs banned by the Centre includes a commonly used medication - Nimesulide and paracetamol combination - which is used to relieve pain and fever
The Ministry of Health and Family Welfare released the first NLEM in 1996. It contained 279 medicines. The list was subsequently revised in 2003 and had 354 medicines
Glenmark Pharmaceuticals on Thursday said it has launched a novel fixed-dose combination (FDC) drug in the country for patients with uncontrolled asthma. The Mumbai-based drug major has launched - Indacaterol + Mometasone FDC under the brand name Indamet. The drug will be available in three strengths with a fixed dose of Indacaterol 150 mcg and variable doses of Mometasone 80 mcg, 160 mcg and 320 mcg to be taken once daily. "Respiratory is a key focus area for Glenmark, and the company leads from the front in providing access to the latest treatment options to patients. "We are proud to introduce this novel fixed-dose combination Indamet, which is the first of its kind in India, offering an affordable treatment option to both adults and adolescents 12 years of age and older suffering from uncontrolled asthma," Glenmark Pharmaceuticals Group Vice President & Head (India Formulations) Alok Malik said in a statement. The drug maker is the first company in India to market the FDC of .
The company's board will meet on February 9, 2022 to consider the proposal for buyback of equity shares of the company through tender offer route.
The momentum indicator for FDC has reversed from the overbought territory which hints of further positive momentum in the counter
The price per tablet is Rs 55 for both the variants
In the past two months, FDC has outperformed the market by surging 25 per cent, after reporting a healthy September quarter earnings (Q2FY20)
FDC rallied 11% to Rs 319, while V-Mart surged 7% to Rs 1,960 on the BSE in intra-day trade.
The stock hit a 52-week high of Rs 280, up 10%, extending its previous days 6% surge, after the board approved buyback proposal at a price of Rs 350 per equity share through tender offer.
The stock was up 7% to Rs 256 on BSE ahead of board meeting today to consider share buyback proposal and unaudited financial results for the quarter ended December 2017.
The stock was up 6% to RS 195 on the BSE.
USFDA carried out the audit in relation to cGMP norms and the ANDA filed by the company for dorzolamide ophthalmic solution from the unit
Controversy arose after Centre banned 344 fixed dose combination drugs