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Quarterly results:Alembic reports revenue for Q1 FY23 Rs. 1262 Cr.

 

Financial Highlights

India Branded Business Ex of Covid related products grew by impressive 20%.

International Generics Business de-grew by 3% to Rs. 549 Cr.

 

Vadodara, August 4th, 2022

Alembic Pharmaceuticals Limited reported its consolidated financial results for the quarter ending 30th June, 2022

Mr. Shaunak Amin, Managing Director, Alembic Pharmaceuticals Limited said “India Branded Business continues to deliver robust numbers in Q1. India Business will witness market outperforming growth across most of the products and therapy areas in current year.”

 

Mr. Pranav Amin, Managing Director, Alembic Pharmaceuticals Limited said “It was tough quarter with significant price erosion in the US market, we also charged off a non-recurring expense of Rs. 115 Cr.”

 

Profit before tax for the quarter is Rs. 47 Cr. before charging off the above non-recurring expense.

 

Operational Highlights

International Generics

7 ANDA filed in Q1 FY23. Cumulative ANDA filings at 237.

8 ANDA approvals received in Q1 FY23 Cumulative ANDA approvals 167.

US Generics at Rs. 367 Cr. in the Q1 FY23.

Ex-US International Formulations at Rs.182 Cr. in the Q1 FY23.

 

India Branded Business

India Branded Business at Rs. 480 Cr. in the Q1 FY23.

Ex of Covid related products, growth of India Branded Business is 20%.

 

API

API business at Rs. 233 Cr. in the Q1 FY23.

1 DMFs were filed in the quarter.

 

 

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 5500+ 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)

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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 Pharmaceuticals announces its wholly owned subsidiary, Aleor Dermaceuticals Limited receives USFDA Final Approval for Lidocaine and Prilocaine Cream USP, 2.5%/2.5%.

Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly owned
subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US
Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for
Lidocaine and Prilocaine Cream USP, 2.5%/2.5%. The approved ANDA is therapeutically
equivalent to the reference listed drug product (RLD) EMLA Cream, 2.5%/2.5%, of Teva
Branded Pharmaceutical Products R&D, Inc. Lidocaine 2.5% and Prilocaine 2.5% cream (a
eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on normal intact skin for local analgesia and genital mucous membranes for
superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine 2.5% and
Prilocaine 2.5% cream is not recommended in any clinical situation when penetration or
migration beyond the tympanic membrane into the middle ear is possible because of the
ototoxic effects observed in animal studies
Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US$29
million for twelve months ending Dec. 2021 according to IQVIA.

Alembic has received a cumulative total of 163 ANDA approvals (140 final approvals and 23
tentative approvals) from USFDA.
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 https://www.alembicpharmaceuticals.com/;

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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 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)

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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)

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Alembic Pharmaceuticals Q3 Net Profit up 38% to Rs 234 crores

Vadodara, January 22nd, 2020
Alembic Pharmaceuticals Limited reported its consolidated financial results for the quarter ending 31st December 2019.
Financial Highlights 
Revenue for the quarter up 19% to Rs 1209 crores from Rs. 1018 crores 
Net Profit for the quarter up 38% to Rs 234 crores from Rs 170 crores 
Mr. Pranav Amin, Managing Director, Alembic Pharmaceuticals Limited said “It was a good quarter for the company led by strong growth in the International Markets. We launched 7 products in the US market during the quarter.” 
Operational Highlights 
International Business
International formulations grew 48% to Rs 664 crores in the quarter. 
US Generics grew 61% to Rs 515 crores in the quarter.
Ex-US Sales grew 15% to Rs 149 crores in the quarter.
8 ANDA approvals received during the quarter and total tally stand at 110.
6 ANDA filings during the quarter; Cumulative ANDA filings at 176 
India Formulations Business
The India formulations business was Rs 368 crores for the quarter as against Rs 365 crores last year.
API Business
The API business grew 2% to Rs 553 crores as against Rs 540 crores .
2 DMF were filled in the quarter.