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News about Quality / GMP
US FDA conducts pre approval inspection at Laurus Labs' facility
The inspection was conducted at Visakhapatnam facility
Quality / GMP | 31/10/2022 | By Sudeep Soparkar | 1326
Lupin gets Form 483 for Pune's biotech facility
The inspection concluded with the issuance of Form 483 with seventeen observations
Quality / GMP | 21/10/2022 | By Sudeep Soparkar | 914
US FDA issues four observations to Alembic Pharma's Panelav plant in Gujarat
The facility was inspected from October 4 to October 14, 2022
Quality / GMP | 19/10/2022 | By Sudeep Soparkar | 607
US FDA grants tentative approval for Zydus' for Valbenazine and Roflumilast tabs
Both medicines will be produced at the group's formulation manufacturing plant in Ahmedabad Special Economic Zone
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Quality / GMP | 17/10/2022 | By Sudeep Soparkar | 631
Unichem Labs bags ANDA approval from US FDA
Unichem's Ghaziabad plant will commercialise the product
Quality / GMP | 17/10/2022 | By Sudeep Soparkar | 979
EDQM conducts GMP inspection at Biocon's API site in Bengaluru
As per the filing, the inspection was held between September 12-14, 2022 and issued a list of deficiencies on October 5, 2022
Quality / GMP | 10/10/2022 | By Sudeep Soparkar | 495
Zydus Lifesciences-led arm bags US FDA approval for Brivaracetam tabs
The medicine would be produced at the group's formulation manufacturing plant in Ahmedabad Special Economic Zone
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Quality / GMP | 06/10/2022 | By Sudeep Soparkar | 391
US FDA issues EIR to Suven Pharma's subsidiary
The pre-approval inspection was conducted between July 25 to July 29, 2022
Quality / GMP | 04/10/2022 | By Sudeep Soparkar | 806
Quality / GMP | 04/10/2022 | By Sudeep Soparkar | 407
Zydus Lifesciences bags US FDA approval for Sildenafil for Oral Suspension
The drug will be manufactured at the group’s formulation manufacturing facility at Baddi, Himachal Pradesh
Quality / GMP | 03/10/2022 | By Sudeep Soparkar | 475
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