Pharmaceuticals manufacturer Alkem Laboratories said its bioequivalence center at Taloja in Maharashtra has successfully undergone a US FDA inspection without attracting any adverse remarks.
“US FDA had conducted a remote and virtual Bio-Analytical inspection of the Company’s Bioequivalence Center located at Taloja, Maharashtra from 26th July, 2021 to 28th July, 2021. At the end of the inspection, no Form 483 was issued,” the company said today.
Bioequivalence refers to testing whether two drugs or preparations are similar or the same in their effects in the target living organism. India has around 100 such facilities, though not all of them may be approved by the US FDA.
Technically speaking, two pharmaceutical products are bioequivalent if “they are pharmaceutically equivalent and their bioavailabilities (rate and extent of availability) after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, can be expected to be essentially the same. “
Such substances can then be sold as an equivalent generic replacement for a branded product in the market, usually at a fraction of the cost.
The Alkem Bioequivalence Center has 112 beds and a bio-analytical laboratory. It conducts bioequivalence and bioavailability studies on volunteers to prove the safety and effectiveness of developed formulations.
The facility has cleared cleared multiple inspections by DCGI, USFDA, UK-MHRA, NPRA (Malaysian agency) and ISP-Chile.
Alkem has received many product approvals from various regulatory bodies based on the results of bioequivalence studies at this facility.
FORM 483
Generally, US FDA issues a Form 483 if it notices any discrepancy during its inspection of a company’s testing or manufacturing facility.
Such deviations are considered to be a violation of the US Food Drug and Cosmetic (FD&C) Act and related provisions.
Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.