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
Company attributes the huge spike to a strong show in the international markets
The company reported a net profit of Rs 301 crore in Q1FY21, against Rs 124 crore in the year-ago quarter.
These companies reported an increase in revenue and/or profit before tax for the March quarter
Strong brand recall, an efficient sales force, a growing network of supportive doctors and timely product launches are the key catalysts for this business
The product was indicated for the topical treatment of acne vulgaris in patients 12 years of age and older, Alembic Pharma said
In the past four weeks, Alembic Pharma outperformed the market by surging 41 per cent as compared to Sensex's 1.1 per cent gain
The stock is close to its all-time high level of Rs 792, hit in July 2015
Last week, the stock hit a fresh 52-week high of Rs 706 on the BSE
Doxycycline hyclate tablets are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients
Alembic now has a cumulative total of 118 ANDA approvals from the USFDA
Azithromycin tablet is a macrolide antibacterial drug indicated for mild to moderate infections
This financial year should see 15-20 product launches in the US
Drug firm Alembic Pharmaceuticals on Wednesday said it has received final nod from the US health regulator for Tizanidine hydrochloride capsules, used to treat spasticity. "The company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg," the drug firm said in a regulatory filing. Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important. "The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zanaflex Capsules, 2 mg, 4 mg, and 6 mg, of Covis Pharma BV," the filing said. Tizanidine hydrochloride capsules, 2 mg, 4 mg, and 6 mg have an estimated market size of USD 28 million
Alembic said it has a cumulative total of 104 abbreviated new drug application (ANDA) approvals from USFDA
Alembic Pharmaceuticals board also constituted NCD Committee for issue and allotment of NCDs
The approved product is therapeutically equivalent to AstraZeneca Pharmaceuticals' Xylocaine ointment, 5 per cent
International formulations sales grew to Rs 5.87 billion from Rs 2.62 billion in the year-ago period, the company said
The stock has moved higher by 8% to Rs 530, bouncing back 11% from early morning low of Rs 478 on the BSE.
The stock is locked in upper circuit of 20% at Rs 522 after the company received approval from the USFDA for its ANDA Bupropion hydrochloride tablets USP, 75 mg and 100 mg.