US FDA has issued an Establishment Inspection Report (EIR) for Alkem Labs's Ankaleshwar API Facility which was inspected in December 2016. The inspection has now been closed by the US FDA.
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Divi's Laboratories Limited got Import Alert 66-40 issued by US-FDA on products manufactured at the company’s Unit-II at Yisakhapatnam, Andhra Pradesh
The choice of President Donald Trump to head the US Food and Drug Administration is among the strongest advocates of lowering drug costs by quickly approving cheap generics, an initiative aimed directly at profit centers Of large companies.
The Department of Biotechnology (DBT), India and the Netherlands Organization for Scientific Research (NWO) / the Netherlands Organization for Health Research and Development (ZonMw) will soon jointly initiate research on Health care. This program provides funding opportunities for joint research cooperation between Dutch and Indian research groups.
Three strategic issues to be addressed under this program. First, how can technology support people's health and well-being in order to help them function and participate in society outside of organized care? The point is to focus on health rather than on health care. By focusing on prevention, health and wellness, you reduce the need for professional health care. Second, how can technology make it easier for people to get closer to home? In many cases, it is more cost effective and better for patients to provide care outside of health care facilities. Chronic care should not be managed in hospitals. Rehabilitation should take place closer to home or even at home. Third, how can technology enable more effective and personalized care? Technology allows us to do more with less. The technology can allow for early and individualized diagnosis and prognosis, less invasive treatment and change work processes all together.
The purpose of this joint research program is to stimulate a sustainable Indian-Dutch research collaboration by funding joint research projects in the field of medical devices with the explicit objective of contributing to more sustainable health care in India or Netherlands. It also aims to develop innovative technologies for a sustainable health system.
In addition to providing solutions to the above questions, another objective is to stimulate the Dutch and Indian research fields of medical devices on the minimally invasive techniques.
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Meropenem Injection 500 mg/vial and 1 g/vial. Aurobindo’s Meropenem injection is a generic equivalent of AstraZeneca Pharmaceuticals’ Merrem® Injection. The product will be launched immediately.
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Abacavir Sulfate and Lamivudine tablets, 600 mg/300 mg. Aurobindo’s Abacavir Sulfate and Lamivudine tablets are the AB rated generic equivalent of VIIV Healthcare Company’s Epzicom tablets.
Parliament passed a bill that aims to decriminalize the suicide attempt of people with mental illness and provides for the right to better health care for people with mental illness.
National drug pricing authority NPPA has identified 634 cases where non-compliance with the notified price ceilings is suspected, Parliament has been informed.
Niti Aayog has developed two bills to regulate and promote Indian medicine systems that include ayurveda, yoga and naturopathy and homeopathy.The bill of the National Commission for Indian Systems of Medicine (NCISM), 2017 will cover Ayurveda, Unani, Siddha and Sowa-Rigpa, yoga and naturopathy. The draft of the National Commission for Homeopathy Act of 2017 will also cover biochemical remedies.
The European Medicines Agency (EMA) said the suspension was ordered for all drugs for which bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India. Comment from Micro Therapeutic Research Labs could not be obtained.