Posted on Leave a comment

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)

Posted on Leave a comment

Lupin gets USFDA nod for generic product

Drug firm Lupin on Saturday said it has received approval from the US health regulator to market Sevelamer Carbonate for Oral Suspension, used in the control of serum phosphorus with chronic kidney disease (CKD) on dialysis.

 


The company has received approval from the United States Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) Sevelamer Carbonate for Oral Suspension in the American market, Lupin said in a statement.

This product will be manufactured at the company’s Goa facility, it added.

As per IQVIA MAT September 2021 data, Sevelamer Carbonate for Oral Suspension had estimated annual sales of USD 51.7 million in the US.

Posted on Leave a comment

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.

Posted on Leave a comment

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

Posted on Leave a comment

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)

Posted on Leave a comment

Profit before Tax up 36% to Rs 406 crores for the quarter

Net Profit up 35% to Rs 333 crores

Vadodara, October 22nd, 2020

Alembic Pharmaceuticals Limited reported its consolidated financial results for the quarter ending 30th September 2020.

Financial Highlights

  • Net Sales for the quarter up 17% to Rs 1457 crores from Rs. 1241 crores.
  • Net Profit for the quarter up 35% to Rs 333 crores from Rs 246 crores.
  • Net sales for H-1 FY21 up 28% to Rs 2798 crores against Rs 2190 crores.
  • Net profit for H-1 FY21 up 72% to Rs 635 crores from Rs 370 crores.

Mr. Pranav Amin, Managing Director, Alembic Pharmaceuticals Limited said “It was a strong quarter for the company led by growth in the domestic business. The International as well as API Business also continued to perform well.”

Operational Highlights

International Business

  • International formulations grew 21% to Rs 779 crores in the quarter and 41% to Rs 1550 crores for H-1.
  • US Generics grew 8% to Rs 582 crores in the quarter and 33% to Rs 1177 Crores for H-1.
  • Ex-US International Formulations grew 84% to Rs 197 crores in the quarter and 73% to Rs 373 Crores for H-1.
  • 6 ANDA approvals received during the quarter; 131 Cumulative ANDA approvals.
  • 7 ANDA filings during the quarter; Cumulative ANDA filings at 198.

India Formulations Business

  • India formulations business grew 6% to Rs 415 crores in the quarter and was Rs 721 crores for H-1.

 

API Business

  • API business grew 29% to Rs 263 crores in the quarter and 40% to Rs 528 crores for H-1.
  • 2 DMF were filed in the quarter.

 

Summary of Total Revenue is as under:

                                        (Rs in Crores)

Particulars Q2 FY21 Q2 FY20 % Change H-1 FY21 H-1 FY19 % Change
Formulation
  USA

Ex- US

582

197

539

107

8%

84%

1177

373

883

216

33%

73%

  India 415 391 6% 721 715 1%
API 263 204 29% 528 376 40%
Total 1457 1241 17% 2798 2190 28%

Summary of Profit is as under:                                                        (Rs in Crores)

Particulars Q2 FY21 Q2 FY20 % Change H1 FY21 H1 FY20 % Change
EBITDA Pre R&D 628 505 24% 1177 836 41%
EBITDA Pre R&D % 43% 41%   42% 38%  
EBITDA Post R&D 455 342 33% 871 542 61%
EBITDA Post R&D % 31% 28%   31% 25%  
Profit Before Tax 406 299 36% 775 458 69%
Net Profit after Tax 333 246 35% 635 370 72%

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 US FDA. 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 the company can be found at   www.alembicpharmaceuticals.com; (reuters:ALEM.NS) (bloomberg:ALPM) (nse:APLLTD) (bse:533573)

Posted on Leave a comment

Alembic Pharmaceuticals achieves 23% growth in net profit of quarter in comparison to last year.

Press Release

Vadodara, 24th October, 2019

Alembic Pharmaceuticals Limited reported its consolidated financial results for the quarter ending 30th September 2019.

Financial Highlights

·         Net Sales for the quarter up 10% to Rs 1241 crores from Rs. 1127 crores last year.

·         Net Profit for the quarter up 23% to Rs 246 crores from Rs 200 crores last year.

·         Net sales for H-1 FY20 up 10% to Rs 2190 crores against Rs 1990 crores last year.

·         Net profit for H-1 FY20 up 27% to Rs 370 crores from Rs 291 Crores last year.

Mr. Pranav Amin, Managing Director, Alembic Pharmaceuticals Limited said  

“It was a good quarter for the company led by growth in the US market and the API business. We launched 7 products in the US market in Q2. We continue to invest in R&D to build up a product pipeline.”

Operational Highlights

International Business

·         International formulations grew 10% to Rs 646 crores in the quarter and 17% to Rs 1099 crores for H-1.

·         US Generics grew 25% to Rs 539 crores in the quarter and 35% to Rs 884 Crores for H-1.

·         6 ANDA approvals received during the quarter; 102 Cumulative ANDA approvals.

·         5 ANDA filings during the quarter; Cumulative ANDA filings at 170.

·         EIR’s for all the plants in place.

India Formulations Business

·         India formulations business for the quarter was Rs 391 crores as against Rs 385 crores for the last year.

API Business

·         API business grew 31% to Rs 204 crores as against Rs 155 crores for the last year.

·         2 DMF were filed in the quarter and total tally of DMF stand at 102.

Summary of Total Revenue is as under:   

                                     (Rs in Crores)

Particulars

Q2 FY20

Q2 FY19

% Change

H1 FY20

H1 FY19

% Change

Formulation

USA 

539

431

25%

884

656

35%

Ex-USA                            

107

156

-31%

215

283

-24%

India

391

385

2%

715

716

0%

API

204

155

31%

376

335

12%

Total

1241

1127

10%

2190

1990

10%

                                         


The Profit break-up is as under:               

                                                                                                                 (Rs in Crores)

Particulars

Q2 FY20

Q2 FY19

% Change

H1 FY20

H1 FY19

% Change

EBITDA Pre R&D

505

443

14%

869

710

22%

EBITDA Pre R&D %

41%

39%

40%

36%

EBITDA Post R&D

342

305

12%

575

456

26%

EBITDA Post R&D %

28%

27%

26%

23%

Profit Before Tax before exceptional items

299

270

10%

491

392

25%

Net Profit after Tax

246

200

23%

370

291

27%

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 US FDA. 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 the company can be found at www.alembicpharmaceuticals.com; (reuters: ALEM.NS) (bloomberg: ALPM) (nse: APLLTD) (bse: 533573)