News about Quality / GMP

Strides flagship facility in Bengaluru receives US FDA inspection closure

The company's flagship facility was inspected by the US FDA between December 5 and 9, 2022, and a form 483 listing three inspectional observations was issued

Quality / GMP | 24/02/2023 | By Sudeep Soparkar |  811

Andhra University, US FDA to conduct workshop on pharma cGMP

The workshop will be held in Visakhapatnam on February 23 and 24

Quality / GMP | 23/02/2023 | By Sudeep Soparkar |  655

Piramal Pharma gets EIR for Lexington, Kentucky facility

The inspection has been successfully completed<br />

Quality / GMP | 20/02/2023 | By Sudeep Soparkar |  730

US FDA gives tentative approval to Zydus Lifesciences for Bosentan tabs, oral suspension

The drug will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad

Quality / GMP | 16/02/2023 | By Sudeep Soparkar |  504

Zydus Lifesciences bags tentative US FDA approval for diabetes drug Canagliflozin

The drug will be manufactured at the group's formulation manufacturing facility at Moraiya

Quality / GMP | 16/02/2023 | By Sudeep Soparkar |  493

Aurobindo Pharma gets VAI classification from USFDA for Telangana facility

An API intermediate facility situated at Gundlamachnoor Village, Sangareddy District, Telangana, was inspected by the US FDA from November 10 to November 18, 2022

Quality / GMP | 15/02/2023 | By Sudeep Soparkar |  904

NATCO submits ANDA with US FDA for Olaparib tabs in US

Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic and prostate cancer.

Quality / GMP | 15/02/2023 | By Sudeep Soparkar |  1030

Solara Active Pharma Sciences' Cuddalore facility completes EU GMP Inspection

The inspection was carried out jointly by the State Institute for Drug Control (SUKL), Ministry of Health of the Czech Republic and National Authority of Medicines and Health Products (INFARMED), Portugal from February 7 to 9, 2023
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Quality / GMP | 15/02/2023 | By Sudeep Soparkar |  611

Sun Pharma recalls more than 34,000 bottles of generic medication in US

The lot was manufactured at the Mumbai-based drugmaker's Halol-based manufacturing facility in Gujarat that has failed dissolution testing

Quality / GMP | 13/02/2023 | By Sudeep Soparkar |  884

Lupin bags US FDA approval for Glycopyrrolate injection

This is the first approval from Lupin’s injectable facility in Nagpur

Quality / GMP | 13/02/2023 | By Sudeep Soparkar |  564