News about Quality / GMP

Jubilant Generics Roorkee facility receives USFDA's communication on classification report

Jubilant Generics Roorkee facility receives USFDA's communication on classification report

As per the filing, the company currently supplies one product to the US market that contributes low single-digit revenue to Jubilant Pharmova revenues

Quality / GMP | 31/10/2022 | By Sudeep Soparkar 1662

US FDA conducts pre approval inspection at Laurus Labs' facility

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 1400

Lupin gets Form 483 for Pune's biotech facility

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 946

US FDA issues four observations to Alembic Pharma's Panelav plant in Gujarat

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 689

US FDA grants tentative approval for Zydus' for Valbenazine and Roflumilast tabs

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 720

Unichem Labs bags ANDA approval from US FDA

Unichem Labs bags ANDA approval from US FDA

Unichem's Ghaziabad plant will commercialise the product

Quality / GMP | 17/10/2022 | By Sudeep Soparkar 1029

EDQM conducts GMP inspection at Biocon's API site in Bengaluru

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 523

Zydus Lifesciences-led arm bags US FDA approval for Brivaracetam tabs

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 410

US FDA issues EIR to Suven Pharma's subsidiary

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 849

Lupin bags ANDA from US FDA for Darunavir tabs

Lupin bags ANDA from US FDA for Darunavir tabs

The drugs will be manufactured in Nagpur facility

Quality / GMP | 04/10/2022 | By Sudeep Soparkar 420

 
 

 

 

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