The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of US $282 million in the US
Carbamazepine Tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia
The product will be manufactured at Lupin's facility in Goa, India.
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)
The product will be manufactured at Lupin’s facility in Goa, India.
Ivermectin Cream is a used for the treatment of inflammatory lesions of rosacea.
he US FDA has issued six observations pursuant to the completion of the audit.
The company has responded to the warning letter and carried out the committed corrections.
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