Hospira gets approval from USFDA for Andhra Plant
Pfizer acquired firm Hospira to manufacture finished dosage drugs
Hospira, a generic injectables firm is ready to operate its manufacturing plant in Vishakapatnam-for speciality injections. The decision comes in the wake of an approval from the US Food and Drug Administration post site inspection by the authority. Hospira is stated to have made an investment of $375-450 million to set up the plant.
The US regulator, in the meanwhile, has issued a Form 483, bringing into the notice of the company management of certain objectionable conditions, which has been observed during the site inspection. As implied on the FDA website, observations made in the Form 483 may include violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
In February 2015, Pfizer Inc and Hospira Inc had joined hands to become the world’s leading provider of injectable drugs and infusion technologies and a global leader in biosimilars.
Hospira, a generic injectables firm is ready to operate its manufacturing plant in Vishakapatnam-for speciality injections. The decision comes in the wake of an approval from the US Food and Drug Administration post site inspection by the authority. Hospira is stated to have made an investment of $375-450 million to set up the plant.
The US regulator, in the meanwhile, has issued a Form 483, bringing into the notice of the company management of certain objectionable conditions, which has been observed during the site inspection. As implied on the FDA website, observations made in the Form 483 may include violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
In February 2015, Pfizer Inc and Hospira Inc had joined hands to become the world’s leading provider of injectable drugs and infusion technologies and a global leader in biosimilars.
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