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Aurobindo arm gets USFDA nod
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Aurobindo arm Eugia Steriles' new injectable unit gets 1st product nod from USFDA
Aurobindo Pharma's stepdown subsidiary, Eugia Steriles Private Ltd, has received its first product approval from the US FDA for a new injectables manufacturing facility in Andhra Pradesh. The approved product is Lidocaine Hydrochloride injection in 1% and 2% strengths. This follows an inspection by the USFDA earlier this year.
Aurobindo Pharma's stepdown subsidiary, Eugia Steriles Private Ltd, has received its first product approval from the US FDA for a new injectables manufacturing facility in Andhra Pradesh. The approved product is Lidocaine Hydrochloride injection in 1% and 2% strengths. This follows an inspection by the USFDA earlier this year.
Laurus Labs Hyd API unit completes USFDA inspection
Laurus Labs Ltd reported that its API manufacturing facility in Hyderabad completed a US FDA audit without any Form 483 observations. The inspection occurred from September 9 to 13, 2024, at the IKP Knowledge Park in Genome Valley. This result emphasizes Laurus Labs' adherence to stringent quality and safety standards.
Laurus Labs Ltd reported that its API manufacturing facility in Hyderabad completed a US FDA audit without any Form 483 observations. The inspection occurred from September 9 to 13, 2024, at the IKP Knowledge Park in Genome Valley. This result emphasizes Laurus Labs' adherence to stringent quality and safety standards.
Granules India stock crashes on USFDA concerns
The USFDA issued six observations to Granules India's Gagillapur facility in Hyderabad following an inspection. The company committed to addressing these issues promptly and will submit a response within the stipulated time frame. This inspection covered cGMP and PAI processes, leading to a significant drop in Granules India's stock price.
The USFDA issued six observations to Granules India's Gagillapur facility in Hyderabad following an inspection. The company committed to addressing these issues promptly and will submit a response within the stipulated time frame. This inspection covered cGMP and PAI processes, leading to a significant drop in Granules India's stock price.
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