Reliance Life Sciences Receives Approval from US FDA

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.

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