Anuh Pharma successfully clears USFDA inspection

Published On 2019-09-25 04:00 GMT   |   Update On 2019-09-25 04:00 GMT

"We are pleased to inform you that a successful accomplishment at Anuh Pharma Ltd. was inspected by USFDA (United States Food and Drug Administration) from 16th September 2019 to 20th September 2019 and the same was successful and No 483 Observations were made, " Anuh Pharma said in a BSE filing.


New Delhi: Drug firm Anuh Pharma Ltd has recently announced that the US health regulator has successfully inspected the firm and observations were issued by the United States Food and Drug Administration (USFDA).


The inspection for Anuh Pharma was conducted from September 16, 2019, to September 2o, 2019.


"We are pleased to inform you that a successful accomplishment at Anuh Pharma Ltd. was inspected by USFDA (United States Food and Drug Administration) from 16th September 2019 to 20th September 2019 and the same was successful and No 483 Observations were made, " Anuh Pharma said in a BSE filing.


Form 483 is issued by the USFDA to notify a company’s management of any objectionable condition at its manufacturing facility. The form is issued after completing the inspection.


Anuh Pharma is engaged in the manufacturing of pharmaceuticals, medicinal, chemical and botanical products and operates through Bulk drugs and Chemicals segment. It manufactures active pharmaceutical ingredients (APIs). It also sells bulk drugs and chemicals and produces Macrolides, such as Ertythromycin Base and Ertythromycin Estolate; Higher Macrolides, such as Roxithromycin, Azithromycin and Clarithromycin; Quinolones, such as Levofloxacin Hemihydrate and Ofloxacin; Chloramphenicol, such as Chloramphenicol and Chloramphenicol Palmitate; anti-Tuberculosis (TB) Drug, such as Pyrazinamide, and corticosteroids, such as Betamethasone Sodium Phosphate, Betamethasone Valerate, Betamethasone Dipropionate, Mometasone Furoate, Prednisolone Acetate, Betamethasone Acetate and Clobetasol Propionate.


Its manufacturing operations are located at Tarapur in Maharashtra.


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