MSN Laboratories to setup a facility at Myanmar
MSN Laboratories Private Limited (MSN) enters into a joint venture with Mega Lifesciences Public Company Limited to construct a manufacturing facility located in Zone B at Thilawa Special Economic Zone, Myanmar. The facility will soon manufacture Active Pharmaceutical Ingredients and finished drugs for therapeutic segments including Oncology (Cancer and Tumor), Diabetes and Cardiac ailments in Myanmar. The total capital expenditure agreed for the construction of the new facility will be 35.5 million USD.
The Joint Venture plans to License and market the products manufactured at the Myanmar manufacturing facility mainly across ASEAN, Africa, Latin America and CIS regions. Mega Lifesciences’s strong presence will aid MSN’s Pharma manufacturing & research competence in developing good quality medicines at affordable prices, further strengthen its commitment to emerging market.
MSN Laboratories announces tentative approval of Solifenacin Succinate Tablets in the U.S. Market
MSN Laboratories Private Limited (MSN), today announced receiving a tentative approval for its Abbreviated New Drug Application (ANDA) for Solifenacin Succinate Tablets, with the U.S. Food and Drug Administration (USFDA).Novadoz the subsidiary of MSN will be marketing the product in the US Market. The tablet will be a therapeutically equivalent to the reference listed drug (RLD), Vesicare Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc.
The tablet will provide a therapeutic remedy for overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The Solifenacin Succinate Tablets brand and generic had U.S. sales of approximately $991 million ending in July 2018 according to IQVIA
MSN Laboratories announces tentative approval of Eplerenone Tablets in the U.S. Market
MSN Laboratories Private Limited (MSN), today announced receiving a tentative approval for its Abbreviated New Drug Application (ANDA) for Eplerenone Tablets, with the U.S. Food and Drug Administration (USFDA). Breckenridge Pharmaceutical, Inc. will be marketing the product in the US Market. The tablet will be a therapeutically equivalent to the reference listed drug (RLD), Inspra Tablets, 25 mg and 50 mg, of G.D. Searle, LLC.
The tablet will provide a therapeutic remedy to treat congestive heart failure after a heart attack and can also be used to treat hypertension. The Eplerenone Tablets brand and generic had U.S. sales of approximately $35 million MAT ending in July 2018 according to IQVIA.
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.