Analyses of GMP actions by USFDA on the manufacturer facing the action and likely impact (beneficial) of the same to other competing manufacturers. This report is Event based.
Unichem Laboratories Ltd. announced that, its Goa facility (Plot No. 10 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa, India) received ‘Form 483’ with five observations. This is 1 of 2 USFDA approved facilities owned by the company. Unichem manufactures 33 of the total 58 formulation products manufactured for the US market. This facility manufactures Oral Solids.
The report analyses the impact of the observations on Unichem as well as competitors of products in its Goa Facility.
Granules India Ltd. announced that, its Gagillapur
facility (Gagillapur Village,
Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District, Telangana, India)
received ‘Form 483’ with six observations. Granules India manufactures 21 of
the total 54 formulation products manufactured for the US market. This facility
manufactures Oral Solids.
Baxter’s IV fluid plant at North Carolina (65 Pitts Station Rd, Marion, North Carolina) was damaged by a severe tornado last month and as a result manufacturing operations are shut down. While Baxter has already started the restoration and rebuilding of the facility, but the resolution timeline is not clear.
This report analyses the impact of disruption at Baxter's facility on the marketed drugs.
Indoco Remedies in its press release announced that, its Goa Plant
II & III (Goa Plant-II & III, L-32,33,34, Verna
Industrial Area, Verna, Goa, India) received ‘Form 483’ with seven observations. This is 1 of the 2
USFDA approved facilities owned by the company. Indoco manufactures 24 of the
total 27 formulation products manufactured for the US market in this facility.
This facility manufactures Oral Solids, Injectable and Ophthalmic products.
This report analyses the impact on its marketed products.