News about Quality / GMP

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 |  648

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 |  410

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 |  456

Unichem Labs bags ANDA approval from US FDA

Unichem's Ghaziabad plant will commercialise the product

Quality / GMP | 17/10/2022 | By Sudeep Soparkar |  771

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 |  386

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 |  328

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 |  672

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 |  364

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 |  378

Lupin gets EIR from US FDA for its Ankleshwar facility

The inspection of the facility was conducted from August 16-19, 2022

Quality / GMP | 03/10/2022 | By Sudeep Soparkar |  743