Alkem got EIR from the US FDA
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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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.
BeyondSpring Inc. a global clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, today announced that the Company’s Chief Medical Officer and Head of Business Development, Ramon Mohanlal, M.D., Ph.D., M.B.A., will present clinically and statistically significant data on BeyondSpring’s lead asset, Plinabulin, for the prevention of chemotherapy-induced Neutropenia at this year’s BIO-Europe Spring meeting in Barcelona, Spain.
the Chinese government approved a blueprint called “Healthy China 2030”, pledging to build a healthy China in the next 15 years. By 2030, the size of the healthcare market is expected to reach $2.3 trillion. This initiative is in line with China’s determination to deepen the supply-side structural reforms in 2017 by substantially driving down overcapacity, and increasing efficient supply which call for stricter standards in healthcare industry. The next 15 years will see a surge of investment and changes in the industry.
A question from the Parliament " regarding the influence of vaccine-makers on the immunisation plan" raised the issue of funding the Indian Academy of Pediatrics (IPA), the body representing more than 23,000 pediatricians in India. A look at its finances shows how much depends on the IPA on the financing of the pharmaceutical industry, especially the vaccine manufacturers.