Page 3 - Alembic Pharmaceuticals

Alembic Pharma posts 45% dip in Q1 net at Rs 165 cr amid price erosion

Firm's consolidated revenues from operations also fell marginally to Rs 1,326 cr in Q1FY22, from Rs 1,341 crore a year ago

Alembic Pharmaceuticals gets USFDA nod for bipolar depression drug

Drug firm Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for Lurasidone Hydrochloride tablets, used to treat bipolar depression. The approved product is therapeutically equivalent to the reference listed drug product (RLD) Latuda tablets of Sunovion Pharmaceuticals Inc. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Lurasidone Hydrochloride tablets in the strengths of 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg, Alembic Pharmaceuticals said in a regulatory filing. Quoting IQVIA data, Alembic Pharma said Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg have an estimated market size of USD 3.7 billion for the twelve months ending December 2020. Lurasidone Hydrochloride tablets are indicated for treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Alembic Pharma said it has settled the cas

Alembic Pharma falls 6% post March quarter results

Alembic Pharma Q4FY21 operational performance was marginally below estimates, largely due to lower traction in US and Domestic Formulation (DF) sales

Alembic Pharma Q4 net up 12% to Rs 251 cr on strong API, global businesses

Net sales rise 6% to Rs 1,280 cr; API business expands by as much as 38%

Alembic Pharma's injectables plant launch may face some delay

Company saw Form 483 with observations issued by US FDA for injectables plant in February

Autos, RIL set-off losses in banks; Sensex dips 20 pts, Nifty holds 15,100

The broader markets, however, bucked the trend and ended higher today. The S&P BSE MidCap and SmallCap indices added 0.7 per cent and 0.4 per cent, respectively at close

Alembic's affiliate Rhizen bags US regulator nod for oral cancer drug

Company says a critical cancer inhibiting component in the formulation is the first new chemical entity discovered by Indian scientists to secure US FDA nod

Alembic Pharma gets five observations from USFDA for Gujarat facility

Alembic Pharmaceuticals on Monday said the US health regulator has made five observations after inspection at its facility at Karkhadi, Gujarat. "The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals' New Injectable Facility (F-3) located at Karkhadi from January 29-February 5, 2021. This was a scheduled inspection and at the end of the inspection, the USFDA issued a form 483 with 5 observations, the company said in a regulatory filing. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company's management of objectionable conditions. Alembic Pharma said none of the observations were related to data integrity and were procedural in nature. "The company is preparing the response to the observations, which will be

Alembic Pharma extends decline on mixed December quarter results

Motilal Oswal Securities said Alembic Pharma missed Q3FY21 earnings estimate, weighed by lower-than-expected sales in the US

Alembic Pharma Q3 net up 25% as US formulations business moderates

Consolidated total income rises 9% to Rs 1,316.86 crore

Alembic Pharma gets USFDA nod for pills to treat salt, water retention

Alembic Pharmaceuticals said it received approval from the US health regulator for Metolazone tablets, indicated for the treatment of salt and water retention caused by heart failure or kidney disease

Alembic Pharma gets tentative USFDA nod for breast cancer treatment drug

Drug firm Alembic Pharmaceuticals said it has received tentative approval from the US health regulator for Palbociclib capsules, used to treat a certain type of breast cancer

Samvat 2077: Investors must look for safety first, tone down expectations

Given the sharp volatility, it is preferable to stick to leaders or top-tier players across sectors as they consolidate their position and gain market share

Alembic Pharma's Q2 net profit up 35% at Rs 333 cr on strong domestic biz

Consolidated total income up 17.65 per cent at Rs 1,460.32 cr in Q2 of FY21 as against Rs 1.241.23 cr a year ago

Alembic Pharma reports 35% rise in net profit to Rs 333 cr for Sept quarter

The company had posted a net profit of Rs 246.27 crore for the corresponding period of the previous fiscal, Alembic Pharma said in a filing to BSE

Alembic Pharma JV gets USFDA nod for antifungal topical solution

Drug firm Alembic Pharmaceuticals said its joint venture firm Aleor Dermaceuticals has received final approval from the US health regulator for anti-fungal Tavaborole Topical Solution

Alembic Pharma gets USFDA nod for anti-viral drug Amantadine Hydrochloride

Drug firm Alembic Pharmaceuticals said it has received approval from the US health regulator for Amantadine Hydrochloride tablets, used for treatment of influenza A virus

Stock tips by Nilesh Jain of Anand Rathi: Buy Radico Khaitan, Shoppers Stop

The stock of Radico Khaitan has found the support of its rising trend line and has also formed a reversal candle on the daily chart

Alembic Pharma arm gets tentative USFDA nod for drug to treat hypertension

Alembic Pharmaceuticals said its subsidiary has received tentative approval from the US health regulator for Treprostinil injection indicated for the treatment of pulmonary arterial hypertension

Alembic Pharma Q1 PBT almost doubles to Rs 359 cr, income rises 40%

Company attributes the huge spike to a strong show in the international markets