510(k) Guidance Shifts Away Substantial Equivalence in Favor of Performance Testing and Criteria

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  • July 7, 2021

FDA issued the Safety and Performance Based Pathway Guidance document, superseding the draft guidance document of April 1, 2018. It applies to CDRH and the Center for Biologics Evaluation and Research (CBER). This new pathway represents a considerable change for...

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Sun Pharma Launches Ready-to-Infuse INFUGEM in the U.S.

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  • July 7, 2021

Sun Pharmaceutical Industries Ltd. has announced that INFUGEM™ (gemcitabine in sodium chloride injection), for intravenous use, is now commercially available in the U.S. INFUGEM, the first chemotherapy product that comes in a premixed, ready-to-infuse formulation, was approved by the U.S....

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Lupin receives FDA approval for Testosterone Gel

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  • July 7, 2021

Pharma major Lupin Limited (Lupin) announced that it has received approval for its Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation), from the United States Food and Drug Administration (FDA) to market a generic version of AbbVie, Inc’s (AbbVie) AndroGel...

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Gujarat Industrial Hackathon-2019 Grand Finale

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  • July 7, 2021

Dr. Jaimin Vasa, President, GCCI & member of BoA at Accuprec Research Labs was the Guest Speaker at the Gujarat Industrial Hackathon-2019 - Grand Finale, organized by Higher & Technical Education Department Government of Gujarat On 6th April 2019 at...

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Alcohol warning labels will be now compulsory in India

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  • July 7, 2021

Alcoholic beverages produced after 1st of April, 2019, must have two compulsory warning messages on the labels - ‘Consumption Of Alcohol Is Injurious To Health’ and ‘Be Safe – Don’t Drink and Drive’. https://www.fssai.gov.in/dam/jcr:2c7fb26e-21f7-4e5e-b02d-47a7a32c2730/Notice_Website_Food_License_10_04_2019.pdf

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ICRA: Indian Pharma sector growth to moderate at 8-10% CAGR over FY’2018-21 period

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  • July 7, 2021

The growth trajectory for the Indian pharmaceutical industry is likely to be moderate at 8-10% over FY2018 to FY2021, on the back of healthy demand from the domestic market given increasing spend on healthcare along with improving access. The growth...

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Cipla launches Niveoli, India’s first extrafine ICS-LABA combination HFA inhaler

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  • July 7, 2021

Cipla Limited has announced the launch of Niveoli, India’s first extra-fine particle beclomethasone-formoterol combination hydrofluoroalkane (HFA) inhaler for adults, targeting drug delivery to the small airways. Niveoli is a proprietary Cipla inhaler, and the latest offering from Cipla in respiratory...

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Accuprec BoA Chairman & member mentored MSME officials on IPR

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  • July 7, 2021

National level training program on Intellectual Property Rights (IPR) for senior officers of MSME, Government of India was Organized by CII At EDII. Chief Guest was Mr. Kamal Singh, Head, MSME office, Gujarat, while Guests of honour was Mr. Padmin...

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First Management Forum at DPSRU, New Delhi

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  • July 7, 2021

Delhi Pharmaceutical Sciences & Research University (the first Pharmacy University in India) organized the first management forum on the theme ‘Emerging Dimensions in Hospital Healthcare System’ in its campus on 4th April 2019. This event was organized under the inspirational...

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India’s 1st ever BA-BE Congress on ‘New Paradigms in Generic Drug Development’ organised

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  • July 7, 2021

DIA - Pharmazone organised Bioequivalence Bioavailability Congress on ‘Development of Complex Generics - Challenges and Solutions’ at Renaissance Ahmedabad Hotel. India's 1st ever BA-BE Congress was participated by more than 100 delegates from All over India including Mumbai, Chennai, Delhi,...

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India & Bolivia sign MoU on Traditional Medicine & Homoeopathy

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  • July 7, 2021

The Union Cabinet chaired by Prime Minister Narendra Modi has given ex-post facto approval to the Memorandum of Understanding (MoU) between India and Bolivia in the Field of Traditional Systems of Medicine and Homoeopathy. The MoU was signed in Bolivia...

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Spreading Awareness regarding Haemophilia

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  • July 7, 2021

Haemophilia is an inherited condition that causes bleeding for a long time after injury or surgery and painful swelling of the joints either after injury or even without injury. Let's stay aware and contact a doctor when required. Awareness regarding...

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“Atta” should be mentioned as “Whole Wheat Flour” & Maida as “Refined Wheat Flour,” on Food

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  • July 7, 2021

he Food Safety and Standards Authority of India (FSSAI) has directed packaged- food companies to ensure that they label ‘atta’ as whole wheat flour and ‘maida’ as refined wheat flour. This direction came after the regulator observed that food business...

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Zydus Announces Phase 3 Trial of Desidustat in Non-Dialysis Dependent Chronic Kidney Disease (CKD) P

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  • July 7, 2021

Zydus Cadila, an innovation-driven, global pharmaceutical company, announced the Phase III trials of Desidustat, an Investigational New Drug targeted at treating anemia in non-dialysis dependent chronic kidney disease (NDD-CKD) patients. This Phase III study will be a multicenter (50- 60...

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World Liver Day

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  • July 7, 2021

Liver is one of the most important organs of the body. A healthy lifestyle is important to maintain healthy liver. The Liver is one of the key organs in our body. This World Liver Day, Accuprec staff members took pledge...

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