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STERILE DRUG LICENSING
Hospital pricing part of wider value chain: Max MDAbhay Soi, chairman of Max Healthcare, commented on scrutiny regarding hospital pricing in India. He stated that hospitals should be evalua...- Centre may seek legal view on licensing of sterile drugsThe government is actively exploring a proposal to expand central licensing authority over all sterile drug products following a recent Sup...
- Aragen steps up investment in complex drug modalities; plans 500 KL new CDMO capacityAragen Life Sciences is increasing investments in complex drug modalities and manufacturing. The company plans to add significant small-mol...
- Fake drugs: Karnataka cancels 16 licenses, suspends 8 including that of Pfizer depotKarnataka's FDA raided a farmhouse, seizing spurious drugs and machinery valued at Rs 5.05 crore. The operation allegedly repackaged and re...
- Government to ease BA-BE study norms for domestic generic drug approvals, cut import licence timelinesPharmaceutical companies will soon find it easier to conduct drug studies. Applicants can start eligible trials after intimating the drug r...
- Drugs Panel to weigh bringing all sterile drug products under central licensing amid contamination concernsA proposal will soon be considered to centralize licensing for all sterile drug products. This move aims to tighten regulations on medicine...
- Drug regulator cracks down hard on non-compliant cough syrup makersAuthorities are cracking down on hundreds of cough syrup manufacturers failing quality checks. This action follows tragic deaths linked to ...
- Health Canada sounds alarm on counterfeit Ozempic and Mounjaro as fake drugs surge across Canada, posing serious health risksHealth Canada is issuing a stern warning to Canadians regarding fake versions of popular diabetes and weight-loss medications, including Oz...
- Zydus Lifesciences inks licensing, commercialisation pact with RK PharmaZydus Lifesciences has partnered with RK Pharma Inc of the US. They will collaborate on a new sterile injectable oncology supportive care p...
- Rx dose of quality control medsImplementing the new GMP standard by 36 drug controllers in states and UTs is crucial, along with ensuring transparency and regulator accou...
- Saptagir Laboratories signs deal with Jubilant Generics to manufacture 'Remdesivir'Remdesivir is an experimental antiviral drug developed by Gilead Sciences, Inc. as a course of treatment for Covid-19. Gilead entered into ...
- Government lab starts testing Oxford’s vaccine candidate to determine its sterilityThe Central Drugs Laboratory in Kasauli, Himachal Pradesh, is testing the first batch of the vaccine candidate to determine its sterility —...
- Awaiting critical Remdesivir safety data from companies: DCGIApart from BDR, all have entered into voluntary licensing agreements with Gilead Science, US-based patent holder of this drug. Gilead said ...
- Strides Arcolab gets FDA approval for Oxaliplatin injectionOnco Therapies Ltd, a wholly owned subsidiary of Strides Arcolab today announced that it has received final ANDA approval for Oxaliplatin i...
- Aurobindo Pharma granted 23 registrations by MCC South AfricaCity based generic drug maker Aurobindo Pharma said Medicines Control Council (MCC) of South Africa has granted 23 registrations to manufac...
- US FDA warns Merck to clean up violations at plantThe Food and Drug Administration has ordered Merck & Co to correct numerous manufacturing deficiencies at its main vaccine plant, the lates...
- Strides Arcolab gets approval for Fosphenytoin injectionStrides Arcolab has received its third abbreviated new drug application approval, for Fosphenytoin Injection 50mg/mL in 2 ml and 10 ml vial...
- Strides Arcolab receives USFDA approval for Tobramycin, Tazo PipStrides Arcolab has received second abbreviated new drug application approval for Tobramycin 40 mg/ml.
- Kemwell looks for buyouts in Baltic, taps PEs for new unitBangalore-based pharmaceutical company Kemwell is learnt to be in talks with private equity players for raising funds for a new biologic fa...
- Enforce medical devices standards strictlyA year ago, the Drugs Controller General Of India’s office, the frontline regulatory outfit of the Central Drug Standard Control Organisati...
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