Alembic Pharma Panelav facility gets 4 USFDA observations

Published On 2022-10-19 06:30 GMT   |   Update On 2022-10-19 06:30 GMT
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Vadodara: Drugmaker, Alembic Pharma, has recently announced that the United States Food and Drug Administration (USFDA) has issued a Form 483 with 4 procedural observations after an inspection of the company's Oncology Injectable Formulation Facility located at Panelav, Gujarat.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. 

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The inspection was held from 4th October, 2022 to 14th October, 2022.

"We would like to inform that the United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals' Oncology Injectable Formulation Facility located at Panelav from 4th October, 2022 to 14th October, 2022," the company stated in a recent BSE filing.
"None of the observations are related to data integrity and management believes that they are addressable. The Company is preparing the response to the observations, which will be submitted to the USFDA within stipulated period," Alembic added.
"The Company is committed to maintain the highest quality standards and compliance at all times," the company further added.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat. Alembic Pharmaceuticals Limited is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.

Manufacturing facilities, which cater to the International Generics markets are located at Panelav, Karkhadi, and Jarod in Gujarat. The company's APIs are manufactured at the Panelav and Karkhadi facilities.

Read also: Alembic Pharma subsidiary bags USFDA nod for Adapalene, Benzoyl peroxide topical gel

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