Morepen Laboratories Ltd. has received the prestigious ISO-13485 certification from BSI (British Standards Institution, U.K.) for its State-of-the-art medical devices manufacturing facility at Baddi (Himachal Pradesh). The certification has been awarded for the manufacturing, distribution and after sales service of all point-of-care diagnostic medical devices and their accessories manufactured at the company’s facility in Baddi. The Manufacturing facility and its management systems were rigorously audited by experts and the company has been awarded the certification based on the comprehensive audit procedures undertaken by the notified body.
Morepen Labs USFDA approved plant at Baddi, Himachal Pradesh
The ISO-13485 standard is an international standard which specifies requirements for Quality Management Systems (QMS) that are to be used by an organization involved in one or more stages of the life-cycle of a medical device. This certification is recognized by most regulators across the globe including those in the United Kingdom and the European Union. Compliance with this standard ensures the consistent production, delivery and after sales service of medical devices that are safe for their intended purpose.
Speaking on the development, Mr. Sushil Suri, Chairman and Managing Director, Morepen Laboratories Ltd., said, “This ISO-13485 certification opens new vistas for Morepen to export its diagnostic devices to various countries across the globe and also to seek CE (Conformit Europene) Certification for the European Union. Having complied with all the important technical and regulatory guidelines for the Quality Management Systems as per ISO-13485, the company is confident of securing CE certification for its products as a next step.”
With the grant of ISO-13485 Certification, Morepen Labs’ diagnostic devices are expected to become the preferred choice for customers seeking high quality products manufactured as per best industry practices, Mr. Suri claimed.
Morepen has got state-of-the-art facilities in Baddi (HP) for manufacturing of Medical Devices including Blood Glucose meters, Blood Glucose Testing Strips, Blood Pressure Monitors, Thermometers, Pulse Oximeters, Stethoscopes etc. It is one of the largest manufacturers for Point-of-care diagnostic devices in India by unit volumes, especially for Blood Glucose Monitors with over 3.30 million active users of Glucose monitors in the SAARC region. Having sold over 425 million Blood Glucose Testing Strips, the company enjoys a leadership in the segment and is well positioned to take a lead in home diagnostic products being marketed and promoted under its brand Dr. Morepen Home Health.
Morepen has recently launched a wide range of essential products being required to combat the growing menace of Coronavirus disease and to prevent further spread of this disease in the country. These include non-contact Infrared Thermometers, alcohol-based Hand Sanitizers, Hand Wash, Hand Rubs and 2-Ply/3-Ply Face Masks, all under its umbrella brand – Dr. Morepen.
The Company has also recently received license to manufacture Hydroxychloroquine (HCQ) from State Drug Controller (HP) for its Baddi plant in Himachal Pradesh and is working towards commercializing the production of HCQ in both API as well as tablets form. HCQ is a prescription based drug commonly being recommended to Corona patients under treatment for the disease. India is taking a lead in supplying HCQ to the rest of the world including USA. India is the largest producer of HCQ and will continue to retain its leadership position in this time of crisis.
About Morepen Laboratories Ltd. (www.morepen.com)
Morepen Laboratories Ltd. is a 35 year old, around Rs. 850 Cr. pharmaceutical and healthcare products company. The company went public in the year 1993 and is currently listed at both the Bombay Stock Exchange as well as the National Stock Exchange.
Morepen is engaged in the manufacturing and sale of APIs/Bulk Drugs, Home Diagnostics, Formulations and OTC products. The company’s state-of-the-art manufacturing facility at Baddi (Himachal Pradesh) comprises a scientifically integrated complex of 10 plants, each with a specific product profile.
The USFDA approved plant at Masulkhana is for manufacture of Loratadine, an anti-allergy drug – internationally known as Claritin. Desloratadine and the new blockbuster drug Montelukast is also manufactured at this FDA approved site. The large and spread out manufacturing facility at Baddi has EU GMP & WHO GMP Standards and manufactures latest and much in demand APIs like Atorvastatin, Rosuvastatin, Fexofenadine and others for regulated markets of Europe, USA and also for non-regulated markets across the globe.
Morepen markets over 100 branded formulations under six major therapeutic segments in the domestic market. The company’s manufacturing facilities are backed by a strong dedicated team of research and development (R&D) professionals who ensure stringent quality standards. In Home – Diagnostics business, Morepen has a formidable presence in Blood Glucose Monitors and Blood Pressure Monitors, in the domestic markets. The company’s OTC brands are being promoted under its wholly owned subsidiary Dr. Morepen Limited. Dr. Morepen’s famous OTC product line, including Burnol, Lemolate, Sat-Isabgol, Pain-X and others, has a significant presence in the domestic market.