Glenmark Pharmaceuticals receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules

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  • July 7, 2021

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, a generic version of Nexium Delayed-Release Capsules, 20 mg...

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Health Canada Drafts Policies for Special Access to Medicines Program

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  • July 7, 2021

Health Canada’s Special Access Program (SAP) administers the “SaleFootnote of New Drug for Emergency Treatment” in Part C Division 8 of the Food and Drug Regulations (FDR). These regulations provide authorities that allow drugs unauthorizedFootnote for sale in Canada to...

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Lupin receives EIR for Pharmacovigilance inspection from the U.S. FDA

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  • July 7, 2021

Pharma major Lupin Limited (Lupin) today announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for the Post-marketing Adverse Drug Experience (PADE) inspection, indicating successful closure of the inspection....

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New Roche test aids clinicians in accelerating tuberculosis diagnosis and treatment by detecting ant

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  • July 7, 2021

Roche has announced the CE-IVD launch of the cobas® MTB-RIF/INH test to detect resistance to antibiotics within tuberculosis DNA. This assay is part of the mycobacteria test menu that includes the cobas® MTB and cobas® MAI tests for use on...

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Accuprec co-sponsors IMPULSE 2019 event

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  • July 7, 2021

Ahir Medicos Education & Charitable Trust & Gujarat Ahir Doctors Association has organised IMPULSE 2019 at Palm Greens Club. Total 1400 medical students & medical practitioners attended the event. Accuprec Research Labs Pvt. Ltd, Nagecha Hospital Rajkot & Dr. Kanjibhai...

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Inter-Ministerial meeting for celebration of International Day of Yoga held

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  • July 7, 2021

Inter-Ministerial meeting for forthcoming celebration of International Day of Yoga-2019 was held under the chairmanship of Shri Rajesh Kotecha, Secretary, Ministry of Ayush. Discussion was held with Senior Officers from various ministries of Govt. of India, Eminent experts & Head...

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Workshop on Artificial Bio Organs held in Visakhapatnam

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  • July 7, 2021

In order to strengthen Indo-Australian Cooperation and achieve development of 3D printing industry in both the countries, Andhra Pradesh MedTech Zone (AMTZ) has recently organized a one-day workshop on Organ Bio Printing at the Kalam Convention Center, AMTZ Campus in...

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Biography to tell untold story of Sun Pharma founder Dilip Sanghvi

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  • July 7, 2021

The life and times of reticent billionaire, Dilip Sanghavi, founder of Sun Pharma, one of the India's largest drug makers, will be unravelled in an upcoming book by journalist-author Soma Das, publisher Penguin Random House announced Saturday. Based on interviews...

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Stem cells provide information about neuron resilience in ALS

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  • July 7, 2021

A descriptive illustration of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s Disease. Courtesy of ALS Foundation website. Researchers at Karolinska Institutet in Sweden have developed a stem cell based model in order to study the resilience and vulnerability...

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Shilpa Medicare Limited gets USFDA approval for Two injections

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  • July 7, 2021

“Shilpa Medicare Limited formulation division has received U.S Food and Drug Administration final approval for its ANDA, Docetaxel Injection USP, 20 mg/mL, 80 mg/4 mL (20 mg/mL), and 160 mg/8 mL (20 mg/mL) on 16.05.2019. Docetaxel Injection USP, 20 mg/mL,...

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FDCA GLP audit @ Accuprec

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  • July 7, 2021

FDCA GLP audit was completed at Accuprec Research Labs Pvt. Ltd. The audit was held for renewal of FDCA - GLP. Total 4 members team of FDCA visited Accuprec premise for audit purpose & gave their valuable suggestions for continuous...

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New high-tech laboratory at IICT in Hyderabad

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  • July 7, 2021

A high-tech laboratory aimed at developing pharma and drug intermediates, which are nothing but chemical compounds used as raw materials for production of bulk drugs, was inaugurated at the city-based Indian Institute of Chemical Technology (IICT). The new laboratory, Dr...

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CDSCO releases Risk classification of newly notified Medical Devices, IVDs; Details

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  • July 7, 2021

Through a recent notification, country’s central medical device regulator, the Central Drugs Standards Control Organization (CDSCO) has issued a risk classification of newly notified medical devices and IVDs on the basis of their intended use under the provisions of the...

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Thermo Fisher Scientific to Acquire Manufacturing Site in Ireland

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  • July 7, 2021

Thermo Fisher Scientific Inc.has entered into a definitive agreement to acquire a drug substance manufacturing site in Cork, Ireland, from GlaxoSmithKline plc for approximately €90 million in cash. The Cork site will expand capacity to meet customer demand for the...

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Glenmark Pharmaceuticals receives ANDA approval for Solifenacin Succinate Tablets

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  • July 7, 2021

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Solifenacin Succinate Tablets, 5 mg and 10 mg, a generic version of Vesicare Tablets, 5 mg and 10 mg1...

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