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Torn notebook recording deficiencies, lack of batch manufacturing records, use of unofficial notebooks, lack of audit trails on operation of computer systems, product mix-ups due to manufacturing deficiencies are some of the violations found by USFDA at Cadila Healthcare Ltd's two plants.
BioQ Pharma and Cipla the signed of a strategic distribution, supply and development agreement for the registration and commercialization of BioQ Pharma's Ropivacaine infusion pharmaceutical in India.
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BioQ Pharma Incorporated, a specialty pharmaceutical company focused on the development and commercialization of single-use, large-volume ready-to-use infusible pharmaceuticals, and Cipla Limited, “Cipla,” a global pharmaceutical company that uses cutting edge technology and innovation to meet the everyday needs of all patients, announced the signing of a strategic distribution, supply and development agreement for the registration and commercialization of BioQ Pharma's Ropivacaine infusion pharmaceutical in India.
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF)
Pharma Major Lupin Limited (Lupin) announced that its US subsidiary Lupin Pharmaceutical Inc. has launched its Tri-Lo-Marzia™ Tablets (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg) having received approval from the United States Food and Drug Administration (FDA) to market a generic equivalent of Janssen Pharmaceuticals Inc. (Janssen) Ortho Tri-Cyclen® Lo Tablets, (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg).
For security purposes and to avoid spam health ministry decided that the applicants have to pre-register themselves on online licensing portal - the “SUGAM”. This portal is intended for those who desire to file applications for various services rendered by Central Drugs Standard Control Organization (CDSCO).
Novartis announced today a collaboration with Qualcomm Incorporated through its subsidiary, Qualcomm Life, Inc., in digital innovation with the Breezhaler(TM) inhaler device to treat COPD. Under this collaboration, Qualcomm Life will provide the technology solution for the connectivity of the next generation of the Breezhaler(TM) inhaler, a device used for Novartis' portfolio of COPD treatments of Onbrez(TM) Breezhaler Seebri(TM) Breezhaler, and Ultibro(TM) Breezhaler, the leading LABA/LAMA treatment.
Using a medication prescribed to treat conditions including depression, obsessive-compulsive disorder, anxiety and post-traumatic stress disorder during the first trimester of pregnancy may increase newborns' risk of heart defects, says a study.
Increased sugar levels in blood change the behaviour of blood vessels making them contract more strongly than normal which could result in higher blood pressure and increase the risk of heart attack complications, a study says.
A gene that is known to suppress the growth and spread of many types of cancer has the opposite effect in some forms of colorectal cancer, says a study led by an Indian-origin scientist.
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