Cipla partners with MSN Laboratories for marketing and distribution of generic Xeloda® (Capecitabine Tabs 150mg and 500mg)
Cipla USA, Inc., (“Cipla”) a subsidiary of Cipla Limited, today announced that it has secured rights from MSN Laboratories Private Limited to market & distribute Capecitabine 150mg and 500mg tablets in the United States of America. The product is available immediately. The Capecitabine 150mg and 500mg tablet is an AB-rated generic therapeutic equivalent version of Genentech’s Xeloda®. Capecitabine tablets are indicated as a single agent for adjuvant treatment in patients with Dukes C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred, and also indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. As per IQVIA (IMS Health), Xeloda® and its generic equivalents had sales of approximately $178M for the 12-month period ending June 2018 in the United States.
Novadoz Receives Marketing Approval for Generic Versions of Rosuvastatin, Capecitabine, & Moxifloxacin.
Novadoz Pharmaceuticals, the U.S sales & marketing affiliate of MSN Group (MSN) from Hyderabad, India has received approval to market the company’s first products, Rosuvastatin, Capecitabine, and Moxifloxacin tablets.
MSN received FDA approval for the cholesterol-reducing drug Rosuvastatin Calcium on November 22, 2017. The usage of statin classes of cholesterol reducing agents has increased steadily over the last five years. Moxifloxacin Hydrochloride 400mg, an anti-infective was granted approval by the FDA on September 22, 2017.
MSN’s most recent FDA approval came on July 2, 2018 for Capecitabine 150mg & 500mg tablets. Capecitabine is an oncolytic class of drug, indicated for the treatment of breast cancer. Capecitabine unit sales are trending at 30.1 mil tablets per year, and are increasing at a rate of 5.5% annually.
Commenting on the U.S product launches, Dr MSN Reddy, Chairman - MSN Group commented "This is a major milestone for MSN Group as we are moving up the value chain. Based on our vertical integration model we are hopeful to bring more affordable medicine to the US Market in the near future."
Seshu Akula, President, North America Generics, for Novadoz quotes "The recent approvals for Rosuvastatin, Capecitabine, and Moxifloxacin mark a significant event for the commercialization of MSN Group entrance into the finished dosage business in the U.S Market. Novadoz will benefit from the company’s vertical integration of API & intermediates, expertise in product formulation, along with the company’s ability to manufacture high barrier of entry finished dosage forms. The company expects 12 more ANDA approvals in the next twelve months. Additionally, we will file 20 to 25 ANDAs per year for the next five years providing Novadoz with a deep and extensive product pipeline."
MSN Labs is engaged in the development and manufacturing of API (active pharmaceutical ingredients), and is currently the number two-ranked company in the U.S market for that sector. In addition, the company manufactures finished dosage oral solids, liquids, & injectable products in sixty-five markets throughout the world.
MSN laboratories received final USFDA approval for Capecitabine
MSN Laboratories Pvt. Ltd., received final USFDA approval for the Abbreviated New Drug Application (ANDA) molecule Capecitabine tablet in strengths 150mg and 500mg. It was originally developed by Roche and marketed under the brand name drug Xaloda. It is indicated for the treatment of breast cancer in postmenopausal women.
As per the IQVIA report, the product has USD794.2 million annual sales worldwide and USD 214.2 million for the US market for the year ended December 2017.
The group is backward integrated on the API for this product. MSN group has filed more than 50 ANDAs, 7 of which are approved and one product is currently being marketed in the US.
MSN Life Sciences Private Limited (Unit-II) gets FDA clearance for the second time
Pharma Major MSN Laboratories Pvt. Ltd., today in their official statement mentioned that the US Food and Drug Administration (USFDA) conducted an audit from July 2 to July 5, 2018 at MSN Life Sciences Private Limited, Unit-II (API facility) at Chendampet, Medak. The USFDA has mentioned in their report that the facility is in-line with the regulatory norms with no observations for plant concerns.
The relatively new facility was established in 2014 and has filed around 50 drug master filings with the USFDA till date. This will be the second time the facility has cleared the FDA inspection without any observations. Apart for USFDA the facility is also approved by TGA, Australia.
MSN Laboratories is awarded with "Strategic Business Partner - 2016" by Abbott - Samanvay 2016 - Business Partners Meet
MSN Laboratories wins Pharmexcil Patent Award 2016.
MSN Laboratories wins Pharmexcil Patent Award in the category Bulk Drugs/API - Silver in Pharmexcil 8th Edition of Patent Awards 2015-16. We are proud to receive this honour for our contribution to India's Pharmaceutical Exports during the year 2015-16.
MSN Laboratories has been featured in the "INDIA INNOVATION AWARDS 2015 - TOP 50 list" by Thomson Reuters
Thomson Reuters India Innovation Awards honors the most innovative academic institutions and commercial enterprises headquartered in India for their spirit of innovation in R&D as it relates to Indian patent publications.
Thomson Reuters has identified the top 50 Indian Innovators. In addition, Six awards were presented, two each in the following sectors: Corporate Hi-Tech, Corporate Pharma, and Academic & Government.
MSN Laboratories Wins National Intellectual Property(IP) Award 2016
National Intellectual Property (IP) Awards: 2016 was recently held in New Delhi. Constituted jointly by the Confederation of Indian Industry (CII) and the Indian Patents Office (IPO), the National Intellectual Property Awards are given every year since 2009 recognising the use of IPRs as a strategic tool in commerce and industry.
MSN Laboratories wins National Intellectual Property (IP) Award 2016 in the top Indian private company (MSME) category for patents. We are extremely happy to win IP award for the second time.
MSN Laboratories Wins Pharmaexcil’s Patent Award 2015.
MSN Laboratories wins TV5 Business Leader Award 2015
MSN Laboratories has been awarded TV5 Business Leader award 2015 in the Pharmaceutical (Medium Scale) category.
The award was received by Dr. MSN Reddy (CMD) from Sri Bandaru Dattatreya, Union Minister for Labour and Employment, Sri KT Rama Rao, Telangana State Minister for Information Technology and Sri K E Krishna Murthy, Andhra Pradesh Deputy Chief Minister at Hyderabad International Convention Centre (HICC) on 25th April’15.
TV5 Business Leader award is considered as one of the prestigious awards in South India. TV5, the leader of Telugu News Channels and pioneer in Business News rewards the Businesses that exhibit world-class leadership, outstanding business acumen, best practices and exemplary vision, creating a legacy for others to emulate.
MSN Laboratories is honored to have won this award which exemplify our growth and commitment to provide quality medicines.
Swachh Clinic Campaign
In line with the campaign initiated by our honorable Prime Minister Sri NarenderModi of Swachh BharatAbhiyan, we at MSN Labs have taken it forward to one of the most elite community i.e Doctors. We want to spread the message of Swachh Bharat through doctors to all his patients & staff therefore we have named the campaign Swachh Clinic Campaign where we are taking part of making the doctor’s clinic and surrounding Neat & Clean.
In this Abhiyan we are presenting patient awareness posters, leaflets etc. where doctor is posting message to his patients to keep the surrounding neat & clean. Through this we are trying to get attention of some people of the society and sensitizing them to be responsible to keep his surroundings clean. We will be doing various activities towards Swachhta on every month throughout the year and will try to engage more no of people to be involved and participate towards clean India.
We also invite all our employees of entire MSN Group to support and participates in this abhiyan and make this mission successful in making India clean.
It is yet another step of MSN Labs towards corporate social responsibility.
Swachh Bharat Abhiyan
MSN Laboratories wins EMC Transformer Award 2014
Its gives us immense pleasure to inform that " MSN Laboratories is awarded by Data Storage Giant " EMC" with the " EMC Transformer Award 2014 " at the CIO forum, Delhi on 9 Oct 2014 .
MSN stand " First " among many IT and Non IT giant nominees who competed for this Award.
This award is presented for the Latest Hybrid IT Technologies adapted in our Organization with respect to
the DATA STORAGE AND ARCHIVAL systems, enabling IT as a "Strategic Lever" .
MSN Formulation Facility receives PICS approval (12 Mar 2014)
We are happy inform that the Formulations facility of MSN Laboratories has been certified by PIC/S.
This certification has given us an opportunity to serve people across 44 more countries with state-of-the-art medicines at affordable prices.
MSN successfully completes the audit from FMHACA of Ethiopia. (30 Dec 2013)
The Formulation Division of MSN Laboratories Private Limited successfully completed the audit from Ethiopia on 29 Dec 2013.
MSN labs to invest Rs.150 cr for API, formulations & CRAMS unit in Hyderabad
MSN Laboratories Ltd, a fast growing active pharmaceutical ingredients and formulations company of India is planning to invest Rs.150 crore for setting up an API, formulations and CRAMS (Contract Research and Manufacturing Services) unit in Hyderabad
Started small with a single unit in the year 2003, today the Hyderabad based MSN Group has established 8 units across India of which 6 are manufacturing units catering to APIs, 1 unit for formulations and 1 research and development centre. Out of the 6 manufacturing units 3 units are US FDA certified while the remaining 3 are catering to ROW (Rest of the World) and Indian markets
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CPhI India Pharma Award 2012
MSN Laboratories Limited has been awarded CPhI India Award 2012 for "Innovation in Cost". It recognizes our contribution (1st-in-India generics of Bosentan, Lacosamide, Silodosin, etc. at very affordable prices) to Healthcare in India.
MSN Laboratories successfully completes USFDA audit for the 3rd successive time
Hyderabad based MSN Laboratories has successfully completed US FDA Audit. The group has 55 DMFs for the US market. Out of which 29 DMFs are from this facility.
Commenting on the development, Dr MSN Reddy, chairman & managing director, MSN Group, said, that the 3rd consecutive audit that has been successfully completed by the MSN Group. Achieving this for the 2nd time for the same unit has reiterated our belief and commitment towards quality.
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MSN Labs wins the FAPCCI Outstanding Export Performance Award
Pharmexcil's Outstanding Export Performance Awards
The Outstanding Export Performance Awards and Patent Awards for 2009-10, instituted by the Pharmaceuticals Export Promotion Council (Pharmexcil), were presented to leading pharma companies in a ceremony organized by the Pharmaexcil, as part of Pharma CEOs conclave in Hyderabad last week.
Twelve pharma majors have bagged the Outstanding Export Performance Awards-2009-10 and 24 companies have won Patent Awards for the same year.
The awards were presented by the Chief Minister of Andhra Pradesh, K Rosaiah. Giving away the awards, he said that his government has launched investor friendly industrial policy in the state giving major thrust for pharma and biotechnology sectors.
MSN Laboratories Awarded Emerging India SME 2010
We were awarded the Emerging India SME Award 2010 by ICICI/CRISIL/CNBC_TV18 in Macau (Hongkong) on 10th November 2010.
MSN Laboratories: A master in the making
In less than a decade, MSN Laboratories has consolidated its place as one of the fast growing pharma companies in India. Sachin Jagdale analyses the growth trajectory of the company It has barely been a decade since MSN Laboratories' inception, but the company's achievements would make even the industry veterans give them a standing ovation.
It is never an easy thing to start your own company, and to survive the grueling competition, is even more difficult; but when has a smooth sea made a good mariner: MSN Reddy, Chairman and Managing Director, MSN Laboratories, strongly believes in this philosophy.
MSN Group is one of the fastest growing manufacturers of active pharmaceutical ingredients (APIs) and finished dosages in India. Established in the year 2003, MSN group comprises four API manufacturing plants, one finished dosage facility and a dedicated technology development centre.
MSN Labs A master in the making
MSN Laboratories to set up a new R&D centre in Hyderabad
Hyderabad-based Rs 390 crore formulation and contract research and manufacturing services provider, MSN Laboratories, is setting up a new R&D centre in Hyderabad with an investment of over Rs 40 crore.
The full fledge commercial operation from the new centre will begin by first quarter of 2011. The company has arranged for funds from internal accruals.
New R&D centre in Hyderabad
MSN to make generic of blockbuster heart drug
Hyderabad Based MSN Laboratories has become the first company in India to receive permission to manufacture Prasugrel, the first generic in the world for Efient.
Efient is a blood thinner, which has been launched by Daiichi Sankyo in association with Eli Lily. The drug is expected to be a blockbuster. The former sees sales of more than 500 million through annual sales of the drug in Europe.
Excellence Performance Award in Research & Development for the year 2008-2009
We are happy to inform you that we were awarded the Excellence Performance Award in Research & Development (from FAPCCI)) by the Hon'ble Chief Minister,Govt.of Andhra Pradesh Mr. K. Rosaiah on 5.April.2009 at Hyderabad.MSN Award Photo
MSN Labs setting up R&D unit in Hyderabad
Hyderabad based MSN Laboratories Limited has embarked upon a Rs 150 crore expansion plan to be executed over a period of three years. The expansion programme includes setting up a research and development (R&D) center at Pashamylaram, near here, and construction of a formulation facility at the special economic zone near Jadcherla in Mahabubnagar district.Business Standard
Outstanding Export Performance Award for the year 2008-2009
We are happy to inform you that we were awarded the 'Outstanding Export Performance Award' (from Pharmexcil) by the Honorable Minister of Commerce Mr Anand Sharma in the presence of Chief Minister of A.P and Dr Surinder Singh, DCGI on 25.Sep.2009 at Hyderabad
MSN Successfully completes USFDA, EUGMP Audits
The Hyderabad-based MSN Laboratories Limited, the flagship company of the Rs 150 crore MSN Group of Companies, has successfully completed US FDA and EU GMP audits.
Commenting on the development, Dr M S N Reddy, chairman and managing director, MSN Laboratories, said, "It is a major achievement for us. We have achieved successful recognitions and approvals within a short span of four years of operations. Crossing this audit process has reiterated our belief in quality management and continuous process of innovation. It would help us in making a foray into the US and other regulated markets in the coming years."
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Brickwork Ratings has assigned BWR A to MSN Laboratories
Bangalore: 61% increase in FY-2007. As of 31st January 2009, MSN Labs has achieved 49% increase in PAT.
MSNL s key financial ratios are favorable and improving. In FY 2008, MSNL s debt equity ratio was just 0.71 and even as of 31st Jan 2009 it is about 0.40. Company s debt service coverage ratio improved from 0.25 in FY 2007 to 1.42 in FY2008, to 1.71 as of 31st Jan 2009. Interest coverage ratio improved to 5.64 as of 31st Jan 2009 from 3.86 in FY 2008. Net worth improved to INR 167.69 Million in FY 2008 from INR 102.89 Million in FY 2007, and further improved to INR 256.55 Million as of 31st Jan 2009.
MSN Labs gets EU certification
MSN Laboratories Pvt Ltd has received food manufacturing practice (GMP) certification from the European Union for its active pharmaceutical ingredient manufacturing facility at Pashmylaram near here. The Hyderabad-based company had its first inspection of GMP certification by the EU regulatory body in April, according to a release.
MSN Labs opens Bollarum formulations facility
MSN Laboratories Limited, part of the Hyderabad-based MSN Group, has inaugurated its formulation facility at Bollarum near Hyderabad.
MSN group acquires Armour Pharmaceuticals
Hyderabad based pharmaceutical ingredients manufacturer, MSN group, has acquired Armour Pharmaceuticals Ltd, a city based pharmaceutical formulations unit. The total project cost is Rs 11 crore, according to sources with the MSN group. This includes Rs 4.5 crore for the acquisition. An amount of Rs six core will be spent to revamp Armour. "We are currently active in API segment. This acquisition would scale up our business models and help us to move up our bottom line growth," sources said.