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“We have launched ezetimibe, the first and only generic version of Zetia (Merck) in the United States for the treatment of high cholesterol,”……….http://health.economictimes.indiatimes.com/news/pharma/glenmark-launches-generic-version-of-zetia-in-us-market/55951453
http://www.glenmarkpharma.com/
Glenmark Launches First and Only Generic Version of Zetia® in the United States
Mumbai, India; December 12, 2016: Glenmark Pharmaceuticals Inc., USA today announced the availability of ezetimibe, the first and only generic version of ZETIA® (Merck) in the United States for the treatment of high cholesterol. The availability of ezetimibe is the result of a licensing partnership with Par Pharmaceutical, an Endo International plc operating company, with whom Glenmark will share profits. Glenmark and its partner, Endo will be entitled to 180 days of generic drug exclusivity for ezetimibe as provided for under section 505(j)(5)(B)(iv) of the FD&C Act.
Ezetimibe is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-
C), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in patients with primary
(heterozygous familial and non-familial) hyperlipidemia.
According to IMS Health data for the 12-month period ending October 2016, annual U.S. sales of Zetia®
10 mg were approximately $2.3 billion.
“Glenmark has a deep heritage of bringing safe, effective and affordable medicines to patients around
the world,” said Robert Matsuk, President of North America and Global API at Glenmark
Pharmaceuticals Ltd. “Our partnership with Par to bring the first generic version of ZETIA® to market
only underscores our joint commitment to bridging the gap between patients and the medicines they
need most.”
“We, along with our partners at Glenmark, are proud to be able to offer patients managing their
cholesterol levels the first generic version of ZETIA®,” said Tony Pera, President of Par Pharmaceutical.
“Par remains committed to providing patients access to high quality and affordable medicines.”
Glenmark’s current portfolio consists of 111 products authorized for distribution in the U.S. marketplace
and 64 ANDA’s pending approval with the U.S. Food and Drug Administration. In addition to these
internal filings, Glenmark continues to identify and explore external development partnerships to
supplement and accelerate the growth of its existing pipeline and portfolio.
About Glenmark Pharmaceuticals Ltd.:
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization headquartered at Mumbai, India. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2016). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is primarily focused in the areas of Inflammation [asthma/COPD, rheumatoid arthritis etc.] and Pain [neuropathic pain and inflammatory pain]. The company has a significant presence in the branded generics markets across emerging economies including India. GPL along with its subsidiaries operate 17 manufacturing facilities across four countries and has five R&D centers. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries including the US, EU, South America and India………http://www.glenmarkpharma.com/
About Endo International plc:
Endo International plc (NASDAQ / TSX: ENDP) is a global specialty pharmaceutical company focused on improving patients’ lives while creating shareholder value. Endo develops, manufactures, markets and distributes quality branded and generic pharmaceutical products as well as over-the-counter medications though its operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at http://www.endo.com
OLD CLIP
Dec 08, 2016, 08.16 PM | Source: CNBC-TV18 Glenmark to launch cholesterol drug Zetia in US on Dec 12 Glenmark was the first to file for the generic version of Zetia and it means that after the launch on December 12, only Glenmark and Merck will sell generic Zetia in the US market for the next 6 months. Glenmark is launching cholesterol drug Zetia with 6 months exclusivity in the US on December 12. The company has partnered with Par Pharma on the drug and has a 50:50 profit sharing agreement with Par on Zetia. Glenmark was the first to file for the generic version of Zetia and it means that after the launch on December 12, only Glenmark and Merck will sell generic Zetia in the US market for the next 6 months. Total revenue estimated to be generated is around USD 400-500 million and post profit sharing with Par, Glenmark should make around USD 200-250 million.
////////////Glenmark, Launches, First, Only, Generic Version, Zetia®, United States, ezetimibe, par pharmaceutical, cholesterol, Endo International plc
Indian Ministry for Chemicals and Fertilizers on Thursday conferred 1st India Pharma awards to 12 Indian drug companies under various categories to motivate Indian Pharma and medical devices industries.
As per reports, Union Minister for Chemicals and Fertilizers Ananth Kumar conferred 1st India Pharma awards in Bengaluru on Thursday evening.
Speaking on the occasion, Ananth Kumar said that the Pharma Industry in the country is growing at a higher rate than GDP and needs to be complimented for this.
“Indian government would like domestic Pharma industry to be global leaders,” he said, adding that the government and the Pharma entrepreneurs will work together as team Pharma India, with the aim of serving millions of ailing people. He also assured full support to the industry.
The awards constituted by Department of Pharmaceuticals were given to outstanding Pharma Industries to motivate Indian Pharma and medical devices industries. The winner of the awards are:
CATEGORY OF AWARD NAME OF THE COMPANY
OVERALL INDIA PHARMA EXCELLENCE AWARD CADILA HEALTHCARE LIMITED
INDIA PHARMA LEADER AWARD GLENN SALDANA, CHAIRMAN & MANAGING DIRECTOR, GLENMARK PHARMACEUTICALS LIMITED
INDIA PHARMA COMPANY OF THE YEAR AWARD LUPIN LIMITED
INDIA PHARMA BULK DRUG COMPANY OF THE YEAR AWARD SMS PHARMACEUTICALS LTD
INDIA PHARMA INNOVATION OF THE YEAR AWARD CADILA HEATHCARE LIMITED
INDIA PHARMA RESEARCH AND DEVELOPMENT ACHIEVEMENT AWARD SUN PHARMACEUTICALS INDUSTRIES LTD
INDIA PHARMA CORPORATE SOCIAL RESPONSIBILITY PROGRAMME OF THE YEAR AWARD ABBOTT INDIA LIMTED
INDIA PHARMA MEDICAL DEVICES COMPANY OF THE YEAR AWARD HARSORIA HEALTHCARE PVT LTD
INDIA PHARMA EXPORT COMPANY OF THE YEAR AWARD CAMUS PHARMA PVT LTD
INDIA PHARMA BULK DRUG EXPORT COMPANY OF THE YEAR SMS PHARMACEUTICALS LTD
INDIA PHARMA MEDICAL DEVICES EXPORT COMPANY OF THE YEAR AWARD SCOPE MEDICAL DEVICES PVT LTD
SPECIAL AWARD: PHARMA PSU COMPANY OF THE YEAR AWARD KARNATAKA ANTIBIOTICS AND PHARMACEUTICALS LIMITED, A PSU UNDER DEPARTMENT OF PHARMACEUTICALS
CLIP
pib.nic.in/newsite/PrintRelease.aspx?relid=134291
Jan 8, 2016 – OVERALL INDIA PHARMA EXCELLENCE AWARD. CADILA HEALTHCARE LIMITED. INDIA PHARMA LEADER AWARD. SHRI GLENN …
Press Information Bureau
Government of India
Ministry of Chemicals and Fertilizers
08-January-2016 12:49 IST
India Pharma Awards given by Minister of Chemicals and Fertilizers
The Union Minister for Chemicals and Fertilizers, Shri Ananth Kumar gave away the 1st India Pharma awards in Bengaluru on Thursday evening. The awards constituted by Department of Pharmaceuticals were given to outstanding Pharma Industries to motivate Indian Pharma and medical devices industries. The winner of the awards are:
| CATEGORY OF AWARD | NAME OF THE COMPANY |
| OVERALL INDIA PHARMA EXCELLENCE AWARD | CADILA HEALTHCARE LIMITED |
| INDIA PHARMA LEADER AWARD | SHRI GLENN SALDANA, CHAIRMAN & MANAGING DIRECTOR, GLENMARK PHARMACEUTICALS LIMITED |
| INDIA PHARMA COMPANY OF THE YEAR AWARD | LUPIN LIMITED |
| INDIA PHARMA BULK DRUG COMPANY OF THE YEAR AWARD | SMS PHARMACEUTICALS LTD |
| INDIA PHARMA INNOVATION OF THE YEAR AWARD | CADILA HEATHCARE LIMITED |
| INDIA PHARMA RESEARCH AND DEVELOPMENT ACHIEVEMENT AWARD | SUN PHARMACEUTICALS INDUSTRIES LTD |
| INDIA PHARMA CORPORATE SOCIAL RESPONSIBILITY PROGRAMME OF THE YEAR AWARD | ABBOTT INDIA LIMTED |
| INDIA PHARMA MEDICAL DEVICES COMPANY OF THE YEAR AWARD | HARSORIA HEALTHCARE PVT LTD |
| INDIA PHARMA EXPORT COMPANY OF THE YEAR AWARD | CAMUS PHARMA PVT LTD |
| INDIA PHARMA BULK DRUG EXPORT COMPANY OF THE YEAR | SMS PHARMACEUTICALS LTD |
| INDIA PHARMA MEDICAL DEVICES EXPORT COMPANY OF THE YEAR AWARD | SCOPE MEDICAL DEVICES PVT LTD |
| SPECIAL AWARD: PHARMA PSU COMPANY OF THE YEAR AWARD | KARNATAKA ANTIBIOTICS AND PHARMACEUTICALS LIMITED, A PSU UNDER DEPARTMENT OF PHARMACEUTICALS |
Speaking on the occasion the Shri Ananth Kumar said that the Pharma Industry in the country is growing at a higher rate than GDP and needs to be complimented for this. He said that the government would like domestic Pharma industry to be global leaders. He said that the government and the Pharma entrepreneurs will work together as team Pharma India, with the aim of serving millions of ailing people. Shri Ananth Kumar assured full support to the industry.
References
Click to access First%20India%20Pharma%20Awards%202015.pdf
http://pib.nic.in/newsite/PrintRelease.aspx?relid=134291
http://www.glenmarkpharma.com/common/pdf/Glenn_Saldanha-Profile.pdf
Click to access First%20India%20Pharma%20Awards%202015%20%20Final.pdf
Click to access First%20India%20Pharma%20Awards%202015.pdf
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Melogliptin
Phase III
A DP-IV inhibitor potentially for treatment of type II diabetes.
EMD-675992; GRC-8200
CAS No. 868771-57-7
SEE..http://apisynthesisint.blogspot.in/2015/12/melogliptin.html
See more at: http://organicsynthesisinternational.blogspot.in/p/gliptin-series-22.html
DISCLAIMER…….The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent
/////////
Enrollment Begins of First Patient in Phase II Vatelizumab Trial in Relapsing Remitting Multiple Sclerosis
Glenmark outlicensed Vatelizumab (GBR 500) to Sanofi for all indications in 2011
Mumbai – India, November 4, 2014: Glenmark announced today enrollment of the first patient in a multicenter Phase II clinical trial to evaluate Genzyme’s investigational infusion therapy vatelizumab in patients with relapsing remitting multiple sclerosis (RRMS). The trial, called EMPIRE, is designed to assess the efficacy of vatelizumab vs. placebo in RRMS patients. The safety, tolerability and pharmacokinetics of vatelizumab will also be assessed.
read at
The mechanism of action of vatelizumab, which is developed in a collaboration between Glenmark Pharmaceuticals and Genzyme, is not yet fully understood. However, the researchers believe that it will be able to block VLA-2 on activated immune cells, which may enable the interference with collagen-binding in areas of inflammation, as well as leading to the reduction of inflammatory cascade associated with MS.
“We are excited about the commencement of this trial and are pleased with the continued progress of our partnership with Sanofi/Genzyme,” said the President of Biologics and Chief Scientific Officer of Glenmark Pharmaceuticals Ltd., Michael Buschle. EMPIRE, which will be conducted for 12 weeks, is a global phase 2a/2b double-blind, randomized, placebo-controlled study that will study the efficacy, safety, and dose-response of vatelizumab in 168 patients with active RRMS at55 sites in ten different countries.
Vatelizumab is an immunomodulator. It binds to integrin alpha 2.[1]
| Company | Glenmark Pharmaceuticals Ltd. |
| Description | mAb against integrin alpha(2) (VLA-2; CD49B) |
| Molecular Target | Integrin alpha(2) (VLA-2) (CD49B) |
| Mechanism of Action | Antibody |
| Therapeutic Modality | Biologic: Antibody |
| Latest Stage of Development | Phase I/II |
| Standard Indication | Inflammatory bowel disease (IBD) |
| Indication Details | Treat inflammatory bowel disease (IBD); Treat ulcerative colitis (UC) |
| Regulatory Designation | |
| Partner |
Glenmark bags two accolades at Pharmexcil Awards 2014
read
read at
http://www.glenmarkpharma.co.za/blog/glenmarks-bags-2-gold-accolades-at-pharmexcil-awards-2014
MUMBAI, India, Sep 17, 2014
- Glenmark's first in class TRPA1 antagonist, GRC 17536, has shown positive data in a Phase 2a proof of concept study in patients with painful diabetic neuropathy
Glenmark Pharmaceuticals today announced that its first in class Transient Receptor Potential Ankyrin 1 (TRPA1) antagonist, GRC 17536 has shown positive data in a Phase 2a double blind, placebo controlled, multi-centre, proof of concept study conducted on 138 patients in Europe and India.
A statistically significant and clinically relevant response was seen in a prospectively-identified, substantial sub-group of patients with moderate to severe pain who had relatively intact sensory responses as detected by a standardized testing methodology. GRC 17536 was well-tolerated with no evidence of CNS or other drug related side effects.
Patrick Keohane, Chief Medical Officer, Glenmark stated “Diabetic neuropathy remains a difficult to manage chronic clinical condition with limited therapeutic options. These initial efficacy and safety data with GRC 17536, a peripherally acting novel therapeutic, are encouraging, and Glenmark intends to be ready to file for a Phase 2b dose range finding study in patients with neuropathic pain before the end of this financial year. This announcement also reaffirms our position globally in the development of novel pain therapies”.
Commenting on this result, Dr. Michael Buschle, Chief Scientific Officer & President – Biologics, Glenmark Pharmaceuticals mentioned, “This is very promising and GRC 17536 may be useful for several indications which we will pursue”.
The Glenmark TRPA1 program includes indications in pain as well as respiratory. Inhaled doses of GRC 17536 are also being tested in a Phase 2A proof of concept study in patients with Chronic Cough.
Note on TRPA1
TRPA1 is an ion channel expressed on peripheral and spinal sensory neurons and it mediates pain signal transmission. It functions as a cellular sensor for detecting painful mechanical, biochemical and thermal stimuli that cause sensory nerve hyperactivity during chronic pathologies including chronic pain, inflammation, itch and cough. TRPA1 receptor is shown to induce pain hypersensitivity in animal models of diabetic neuropathic pain and its blockade attenuates pain hypersensitivity as well as later loss of the nerve fibers and their function. GRC 17536 is a potent, selective and first in class antagonist of TRPA1 receptor. Preclinical studies have demonstrated its effectiveness in animal models of neuropathic and inflammatory pain including the peripheral diabetic neuropathic pain, osteoarthritic pain, postoperative pain and chemotherapy induced pain which supports potential utility of TRPA1 blockade in therapeutic pain management.
About Glenmark Pharmaceuticals Ltd
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company and ranked among the top 80 Pharma & Biotech companies of the world in terms of revenues as per SCRIP 100 Rankings. Glenmark is a leading player in the discovery of new molecules both NCEs and NBEs. Glenmark has several molecules in various stages of clinical development and primarily focused in the areas of Inflammation, Pain and Oncology. The company has significant presence in branded formulations across emerging economies including India. Its subsidiary, Glenmark Generics Limited services the requirements of the US and Western Europe markets.
Glenmark Pharmaceuticals to set up a new manufacturing facility in the US
• The facility will be situated in Monroe, North Carolina, USA
• The facility will manufacture oral solids, injectables and topicals over a five year period
Mumbai, India; July 17, 2014: Glenmark Pharmaceuticals Ltd; a research-driven, global, integrated pharmaceutical company plans to set up a new manufacturing facility in the US. The company plans to set up this manufacturing facility at Monroe Corporate Center, North Carolina, USA. The facility will be spread over 100,000 sq. feet (around 15 acre plot) and the company will first begin work on an oral solid unit and thereafter set up manufacturing units for injectables and topicals.
GLEN SALDANHA
CEO GLENMARK
NEW DELHI: Glenmark Pharmaceuticals plans to set up its first manufacturing facility in the US at an estimated investment of over Rs 500 crore to cater to the North American market.
The proposed facility would house three units to produce oral solids, injectables and topicals and begin production by the end of the current fiscal.
“The US is a key strategic market for Glenmark and it is important for us to have a manufacturing base here to serve our growing business in the country,” Glenmark Pharmaceuticals Chairman and MD Glenn Saldanha said in a statement.
The plan to set up a manufacturing facility in the US underlines the fast paced growth the company has witnessed in a short span of eight years in the US market, he added.
The company will first begin work on an oral solid unit and thereafter set up manufacturing units for injectables and topicals, the Mumbai-based firm said.
“Over the next five years, we will make significant investments in this proposed facility and set up three units which will produce oral solids, injectables and topicals,” Saldanha said.
According to industry sources, the company plans to invest over Rs 500 crore on the facility.
With the setting up of a new facility in the US the company would further enhance its manufacturing footprint making it truly global in every sense of the term, he added.
The proposed facility at Monroe, North Carolina, will cater only to the US market and is the company’s first manufacturing facility in North America adding to its list of 14 plants in four countries – India, Brazil, Argentina and Czech Republic.
The company, which operates in North America through its subsidiary Glenmark Generics Inc, has a fast growing business with a robust portfolio of over 90 products authorised for distribution in the US in niche segments like dermatology, hormones, controlled substances and oncology.
Glenmark has nearly 70 abbreviated new drug applications (ANDAs) pending for approval with the US Food and Drug Administration.
link is https://newdrugapprovals.org/
All about Drugs, live, by DR ANTHONY MELVIN CRASTO, Worlddrugtracker, Helping millions, 7 million hits on google, pushing boundaries, one lakh plus connections worldwide, 3 lakh plus VIEWS on this blog in 193 countries
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Glenmark Generics receives final ANDA approval for Telmisartan Tablets
Mumbai, India, July 8, 2014
Glenmark Generics Inc., USA a subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Telmisartan Tablets. Glenmark will commence distribution of the product immediately.
Telmisartan Tablets are Glenmark’s generic version of Boehringer Ingelheim’s Micardis®. Telmisartan is indicated for the treatment of hypertension.
The approval is for the 20mg, 40mg and 80mg tablets. For the 12 month period ending March 2014, Telmisartan garnered annual sales of USD 250 Million according to IMS Health.
Telmisartan, which is the generic version of Boehringer Ingelheim’s Micardis, garnered annual sales of $ 250 million for the 12 month period ending March 2014
New Drug Approvals 