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Alembic Pharmaceuticals receives USFDA Tentative Approval for Ivabradine Tablets, 5 mg and 7.5 mg

 

 

 

 

Alembic Pharmaceuticals receives USFDA Tentative Approval for Ivabradine Tablets, 5 mg and 7.5 mg.Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ivabradine Tablets, 5 mg and 7.5 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen). Ivabradine Tablets are indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use. Ivabradine Tablets are indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses. Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US$ 102 million for twelve months ending December 2021 according to IQVIA. Alembic has received a cumulative total of 164 ANDA approvals (140 final approvals and 24 tentative approvals) from USFDA.

 

 

 

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic’s brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients. Information about Alembic can be found at https://www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLLTD) (BSE: 533573)

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Alembic Quarterly Results: India Formulations business up 23% Net Profit Rs 169 crore

Vadodara, November 10th, 2021
Alembic Pharmaceuticals Limited reported its consolidated financial results for the quarter ending 30th September 2021.
Financial Highlights
Net Sales for the quarter at Rs 1292 crores.
Net Profit for the quarter at Rs 169 crores.
Net sales for H-1 FY21 at Rs 2618 crores.
Net profit for H-1 FY21 at Rs 334 crores.

Mr. Shaunak Amin, Managing Director, Alembic Pharmaceuticals Limited said “India Branded Formulation business has posted a strong growth rate for the second consecutive quarter. This is attributed to the consistent efforts to redefine our business strategy and customer relationships, leading to a strong operational performance, along with a market outperforming growth across all our key product segments and therapy areas.”

Operational Highlights
International Business
US Generics at Rs 348 crores in the quarter and at Rs 716 Crores for H-1.
Ex-US International Formulations at Rs 197 Crores in the quarter and at Rs 394 Crores for H-1.
5 ANDA approvals received during the quarter; 150 Cumulative ANDA approvals.
3 ANDA filings during the quarter; Cumulative ANDA filings at 214.
India Formulations Business
India Formulations Business at Rs 509 crores in the quarter and at Rs 989 crores in the H-1.
Acute & specialty segment grew faster than represented pharma market.

API Business
API business at Rs 239 crores in the quarter and at Rs 519 crores for H-1.
3 DMF were filed in the quarter.

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Alembic Pharmaceuticals announces Financial aide upto 50lakhs for deceased employees due to covid

The employees create a benevolent fund for their late colleagues

Vadodara (Gujarat) [India], May 17: When it comes to Employee welfare with Alembic Pharmaceuticals Ltd it is not just the employer but also the employees who have started a Benevolent Fund and are contributing generously for their departed team members who passed in this second wave of Covid.

The Management of the 114-year-old Alembic Pharmaceuticals Ltd has announced Financial Aid of between 15 lakhs to 50 lakhs to their deceased employees, which is over and above all other benefits applicable. Talking to the media, Mr. Pranav Amin, Managing Director of Alembic Pharmaceuticals said that, the company has always fostered the feeling of Alembic Parivaar. We are deeply saddened by the loss of some of our family members due to the Covid-19 pandemic. The company has decided to support the bereaved family members with financial assistance apart from the existing benefits. We have announced financial aid of a minimum INR 15 Lacs maximum up to INR 50 Lacs for the deceased team members’ family. While we cannot compensate for the loss suffered by the families, we hope that this benefit will help them to rebuild their lives. As we remain committed to the safety and wellbeing of our employees and their families, I strongly urge everyone to take the utmost precaution and safeguard themselves.

Seeing the gesture initiated by the company, the employees of the Alembic group have also come forward and formed an Employee Benevolent Fund, where employees are contributing in the form of either cash or their earned leaves for the team members they have lost. Employees have contributed towards the benevolent fund for individual employees who have passed away due to Covid-19. Employees are generously supporting all, irrespective of whether they know the deceased member or not and irrespective of the professional level of their colleague. These contributions are voluntary and discreet. The funds are accumulated and directly transferred to the legal heirs.

Talking to the media, the HR spokesperson confirmed that the organisation has added a Covid-19 cover for all employees, in addition to the existing mediclaim policy, the cost for which is borne by the company. Also, in the unfortunate event of an employee losing his life, the company’s Financial Aid is a major solace, which is in addition to the EDLI of around 7L, gratuity which is calculated up to the retirement date of 58years, contributions from the Benevolent Fund, plus other statutory benefits.

To give a broad idea, the bereaved family of a junior employee on an annual salary of around 3L will also receive as per the above benefits offered, anything between 25 – 30 L.

This is a testing time for everyone. Many of the staff have been personally impacted by the pandemic and/or have had their family members getting impacted.

Some of the staff has even had to bear personal losses/ loss of colleagues.

During such times, it is only natural to occasionally feel a little low. Due to the same Alembic has engaged a clinical psychologist, whom all Alembians can reach out to, should the employees feel the need. The psychologist has special experience in supporting individuals with stress, anxiety, depression, grief and bereavement-related concerns. The psychologist has been requested by the company to keep the discussions and calls confidential. The psychologist shouldn’t share name or any details with the company management too. The psychologist can be contacted all 7 days of the week between 08 am to 9 pm.

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Alembic Pharmaceuticals recieves USFDA approval for Opthalmic Solution.

Drug firm Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, used to treat certain types of glaucoma and other causes of high pressure inside the eye.

The approved product is therapeutically equivalent to the reference listed drug product (RLD) Cosopt Ophthalmic Solution, 2 per cent and 0.5 per cent, of Akorn Operating Company LLC.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2 per cent and 0.5 per cent, Alembic Pharmaceuticals said in a regulatory filing.

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.

Quoting IQVIA data, Alembic Pharma said Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2 per cent and 0.5 per cent has an estimated market size of USD 80 million for twelve months ending December 2020.

Alembic now has a total of 143 ANDA approvals (125 final approvals and 18 tentative approvals) from

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Alembic Global Holding SA receives USFDA Final Approval for Treprostinil Injection

Alembic Pharmaceuticals announces its wholly-owned subsidiary, Alembic Global Holding SA receives USFDA Final Approval for Treprostinil Injection, 20 mg/20 mL (1 mg/mL), 50 mg/20 mL (2.5 mg/mL), 100 mg/20 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL), Multiple-Dose Vials.

Alembic Pharmaceuticals Limited today announced that its wholly-owned subsidiary Alembic Global Holding SA has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Treprostinil Injection, 20 mg/20 mL (1 mg/mL), 50 mg/20 mL (2.5 mg/mL), 100 mg/20 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL), Multiple-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Remodulin Injection, 20 mg/20 mL (1mg/mL), 50 mg/20 mL (2.5 mg/mL), 100 mg/20 mL (5 mg/mL), and 200 mg/20 mL (10mg/mL), of United Therapeutics Corp. (United). Treprostinil Injection is indicated for the treatment of pulmonary arterial hypertension (PAH;WHO Group 1) to diminish symptoms associated with exercise. In patients with PAH requiring transition from epoprostenol, Treprostinil Injection is indicated to diminish the rate of clinical deterioration. Alembic had previously received tentative approval for this ANDA.

Treprostinil Injection has an estimated market size of US$ 17 million for twelve months ending December 2020 according to IQVIA.

Alembic now has a total of 138 ANDA approvals (121 final approvals and 17 tentative approvals) from USFDA, including this first injectable ANDA approval.

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic’s brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients.

Information about Alembic can be found at http://www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLLTD) (BSE: 533573)