The drug major said its R&D centre -- Integrated Product Development Organisation -- in Bachupally, Hyderabad, underwent a Good Manufacturing Practice and pre-approval inspection by the US Food and Drug Administration (USFDA) in December 2023.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), CellCept for oral suspension, 200 mg/m; of Roche Palo Alto, LLC, it added. The approval bolsters the company's Mycophenolate Mofetil portfolio, which already includes numerous products.
Strides Pharma Science informed in a regulatory filing that the US Food and Drug Administration (USFDA) has closed the inspection conducted between February 20-24, 2023 and has classified the facility from official action indicated (OAI) to voluntary action indicated (VAI).
The company has received an EIR with Voluntary Action Indicated (VAI) status from USFDA for its facility for solid dosages (Plant I) located in Verna, Goa, Indoco Remedies said in a regulatory filing. As per USFDA, a VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
Metronidazole is an antibiotic used on the skin to treat a certain skin disorder -- rosacea, a type of adult acne. The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad.
In November last year, USFDA had issued Form-483 with eight observations each for product and raw material production centres at Lupin's Mandideep-based manufacturing facility. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The Food and Drug Administration's proposed recommendation follows criticism for the accelerated approval pathway, as well as an independent federal review into it after the controversial nod for Biogen Inc's Alzheimer's treatment Aduhelm.
Emergent is seeking the Food and Drug Administration's (FDA)approval for the prescription-free sale of Narcan, its nasal spray form of the drug naloxone. Narcan is already cleared for the treatment of opioid overdose in the country.
Commenting on the audit, GPI Executive Director Priyanka Chigurupati said, "We are glad to have completed yet another audit with minor observations that we will respond to within the stipulated time period".
The significant violations included failure to evaluate the potential effect that changes may have on the quality of intermediates and API, the USFDA stated.
The action follows the recent inspection of the facility by the US Food and Drug Administration (USFDA) in August 2021, the drugmaker said in a regulatory filing.
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