Archive for the ‘Reliance Life Sciences’ Category

Reliance Life Sciences Receives Approval from US FDA

January 12, 2016

The United States (US) drug regulatory body has given permission to Reliance Life Sciences for its Active Pharmaceutical Ingredient (API) manufacturing facility. The facility is situated at DhirubhaiAmbani Life Sciences Center at Navi Mumbai.

On one hand Reliance Life Sciences managed to get approval, while on the other a number of Indian generic drug makers are finding it increasingly difficult to deal with regulatory action from the US Food and Drug Administration (FDA).The US is the biggest pharmaceutical market in the world.

Drugs made by Reliance Life Sciences

Reliance Life Sciences makes cytotoxic APIs, which are used to make medicines for treating cancer. Last week,the US FDA sent an Establishment Inspection Report to Reliance Life Sciences stating that it has approved the facility and the quality systems of manufacturing. The facility will now be able to supply its products to the US market. In August, last year, officials from US FDA had come to inspect the facility. The US FDA has given its nod for two of the next-generation oncology molecules, namely temozolomide, and pemetrexed.

Temozolomide is helpful in the treatment of a type of brain tumor, glioblastoma multiforme, while pemetrexed is used to treat patients with non-small cell lung cancer. A spokesperson of Reliance Life Sciences said that the organization has been constantly working to meet international quality standards pertaining toproducts, infrastructure, people, facilities, processes, and information technology. Considering the present progress, the company will soon become a fully electronic-enabled organization. The Navi Mumbai plant had already received a nod from the European Union.

About Reliance Life Sciences

Reliance Life Sciences is a part of the Promoter Group of the MukeshAmbani-led, Reliance Industries. It has developed business in the fields of biopharmaceuticals, medicine, regenerative medicine, and pharmaceuticals, among others. It is one of the most diverse and integrated initiatives of biotechnology across the globe.

The DhirubhaiAmbani Life Sciences center at Navi Mumbai is setup in sprawling 20 acre complex. It also has a facility in Bangalore, which undertakes clinical pharmacology and clinical data management. Overall, Reliance Life Sciences has more than 800 employees. Many of these have PhDs or are post-graduates in Science. 26% of its employees are women. The average age of the employees at Reliance Life Sciences is 33 years.

Reliance Jio’s 4G Service

The telecom arm of Reliance Industries, Reliance Jio, whose operations are being advised by Chairman MukeshAmbani’sright-hand man Manoj Modi, will roll out its network for testing and feedback to the public in January, itself. It will offer invites and SIM cards to customers who buy its 4G-enabled LYF branded smart phones.

The company will sell the LYF branded handsets along with the 4G service across 500 cities in the country. It may start selling the phones from 14th January and offer heavy discounts on them. Additionally, the company will also offer 20 GB of free data bundled with the phone.

Reliance Jio has a stock of lakhs of LYF mobile phones, which were shipped to its warehouses from November, last year.In the initial stage, it will launch 4 LYF phones – Earth 1, Water 1, Water 2, and Water 3.

Summary

Reliance Life Sciences received approval from the US FDA for its Active Pharmaceutical Ingredient manufacturing facility at Navi Mumbai.

Reliance Life Sciences and TAKE Solutions Enter Into a Strategic Alliance

June 4, 2010

TAKE Solutions Ltd. (BSE: 532890), leaders in Life Sciences and Supply Chain Management (SCM) products, announced that the company has entered into strategic partnership with Reliance Life Sciences to supply its unique and innovative PharmaReady eCTD, SPL and PPM modules. The seamless integration of TAKE Solutions’ technologically advanced products will not only support Reliance Life Sciences in strengthening product development services; but these customized IT solutions will also add a cutting-edge finesse to the present line of business. With its strong background and industry knowledge, TAKE’s Warehousing & Clinical Systems Development and Integration tools will deliver a full spectrum of Information Management Services, leveraging on industry data standards to streamline the clinical information lifecycle. “We were looking out for a submission solution that can address our current and future requirement of our organization that enables our regulatory submissions. Also, in addition to software solutions, we wanted to partner with an organization that understands our business dynamics, and could work with Reliance Life Sciences to enhance the business process and solution set over the time to come. After a detailed market search, and understanding of the solutions available, TAKE Solutions emerged as a definite choice for us as the solution set offered us flexibility and options for customization, while meeting the core requirements. Also, TAKE Solutions as an organization has the right credentials, industry expertise and resource strength that we were looking for.” said Mr. Gopal Rangaraj, Vice President IT, Reliance Life Sciences Pvt. Ltd. “We are extremely pleased to partner with Reliance Life Sciences. Our engagement with such a credible and commended Life Sciences solution major is evidence of TAKE Solutions’ comprehensive understanding of the business, the challenges and proven track record of providing intelligent and innovative clinical regulatory solutions,” said, Mr. Ramesh L, Vice President – Sales, Life Sciences APAC, TAKE Solutions Ltd. Notes to EditorAbout Reliance Life Sciences Reliance Life Sciences, is a new millennium initiative of the Reliance Group. Reliance Group is the largest private sector enterprise in India, participating in businesses in the energy and materials value chain, with group revenues of USD 30 billion. The flagship company, Reliance Industries Limited, is a Fortune Global 500 company, and ranks 103rd amongst the world’s top companies in terms of revenues. Reliance Life Sciences is developing business opportunities in the domains of medical, plant and industrial biotechnology. From a domain perspective, these opportunities cover Biopharmaceuticals, Pharmaceuticals, Clinical Research Services, Regenerative Medicine, Molecular Medicine, Novel Therapeutics, BioFuels, Plant Tissue Culture, Plant Metabolic Engineering and Industrial Biotechnology. From an integration perspective, these opportunities encompass Repositories, Research, Process Development, Pre-clinical Studies, Clinica; Trials, Commercial-scale Manufacture and Marketing, all of which are carried out in-house. About TAKE Solutions TAKE Solutions is a leading software and services provider with domain expertise in Life Sciences (LS) and Supply Chain Management (SCM). With intellectual property assets embedded within its technology solutions, and with a set of best practices executed by skilled domain and technology professionals, TAKE is constantly looking at opportunities to drive efficiencies for its clients’ businesses. Headquartered in Chennai, TAKE primarily drives its SCM Domain Excellence Centre and Global Delivery Centre from India. Company has strong presence in the USA with Life Sciences Domain Excellence centres located in Princeton, New Jersey. The Company conducts business today with more than 390 customers worldwide. TAKE has been recognized as India’s 10th fastest growing technology company by Deloitte Technology Fast 50 India 2008 and has also been assessed at Level 5 of the Capability Maturity Model Integration (CMMI) & Level 3 of the People Capability Maturity Model, Software Engineering Institute, Carnegie Mellon University, USA. TAKE is also a Microsoft Gold Certified Partner, a Charter Member of the Microsoft BioIT Alliance, and along with its subsidiary (ACI), is a Registered CDISC Solution Provider, with recognized industry leadership in Microsoft-based Solutions, Regulated Life Sciences, and Supply Chain Management.

Source:http://news-views.in/reliance-life-sciences-and-take-solutions-enter-into-a-strategic-alliance/