News about Quality / GMP

US FDA conducts Pre-Approval Inspection of oral oncology manufacturing facility in Gujarat

The company has been issued a Form 483 with 1 observation, which is procedural

Quality / GMP | 20/03/2023 | By Sudeep Soparkar |  882

Sai Life Sciences unveils GMP Kilo Lab in Alderley Park, Manchester, UK

The new GMP Kilo Lab will enable Sai Life Sciences to offer drug substances and intermediates supplies ranging from gram to kilogram quantities

Quality / GMP | 16/03/2023 | By Sudeep Soparkar |  814

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 |  901

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 |  1605

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 |  1503

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 |  477

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 |  923

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
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Quality / GMP | 11/03/2023 | By Sudeep Soparkar |  1116

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 |  1777

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 |  876