News about Quality / GMP

Lupin Bioresearch Centre completes US FDA inspection with no observations

Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies

Quality / GMP | 14/03/2023 | By Sudeep Soparkar |  866

Shilpa Medicare gets two minor observations from US FDA at Hyderabad facility

The observations were noticed at Unit VII, Analytical Services Division

Quality / GMP | 13/03/2023 | By Sudeep Soparkar |  1471

Alembic Pharma derma facility in Karakhadi completes successful US FDA inspection

The inspection was completed with no observations

Quality / GMP | 13/03/2023 | By Sudeep Soparkar |  1389

US FDA completes inspection of Lupins Vizag facility with no observations

The inspection was conducted from March 6 to March 10, 2023

Quality / GMP | 13/03/2023 | By Sudeep Soparkar |  364

US FDA assigns VAI classification to Jubilant Pharmova's API facility at Nanjangud

This facility complies concerning current good manufacturing practices

Quality / GMP | 11/03/2023 | By Sudeep Soparkar |  844

Glenmark, Cediprof in agreement for US FDA-approved mixed amphetamines tabs

Glenmark expects to commence distribution of the product in the US during the second half of 2023
<br />

Quality / GMP | 11/03/2023 | By Sudeep Soparkar |  1008

Aurobindo's subsidiary Eugia Pharma Specialities receives final approval from US FDA

Aurobindo's subsidiary Eugia Pharma Specialities receives final approval from US FDA to manufacture, market cancer drug Lenalidomide caps

Quality / GMP | 11/03/2023 | By Sudeep Soparkar |  1603

Arrests made at Noida-based pharma Marion Biotech for cough syrup deaths

The officials were arrested on charges of manufacturing and sale of adulterated drugs

Quality / GMP | 06/03/2023 | By Sudeep Soparkar |  808

Zydus receives US FDA approval for Olmesartan Medoxomil and Hydrochlorothiazide tabs

The company also receives approval for Apixaban Tablets, 2.5 mg and 5 mg

Quality / GMP | 02/03/2023 | By Sudeep Soparkar |  931

Granules India receives ANDA Approval for Losartan Potassium tabs

Granules now have a total of 54 ANDA approvals from the US FDA
<br />

Quality / GMP | 27/02/2023 | By Sudeep Soparkar |  838