Alkem
Laboratories’ manufacturing facility located at Amaliya, Daman, India,
underwent a U.S. FDA inspection from April 20, 2026 to May 1, 2026 concluded
with the issuance of 7 form 483 observations. The inspected site is one of
Alkem’s largest U.S.-focused manufacturing facilities and plays a critical role
in supplying multiple high-volume generic products to the U.S. market.
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Facility Profile: The Amaliya, Daman facility manufactures 68 generic products
for the U.S. market, including tablets, capsules, oral suspensions, solutions,
ER/DR formulations, syrups, granules, and nasal sprays.
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Top Generic
Products Manufactured: Amlodipine
Besylate, Quetiapine Fumarate, Gabapentin, Aripiprazole, Cephalexin.
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Products Likely
Exposed to Shortages (Based on Market
Share >20%, Sales >$3Mn & No Backup Manufacturing): 6 products are exposed
to shortages in the event of an escalation of the GMP issue.
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Revenue
Contribution: The Daman facility
contributes significantly in annual U.S. generic sales, accounting for large
portion of Alkem Laboratories’ total U.S. generic revenue.
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Backup Coverage: A significant portion of the sales from this facility are
supported through alternate manufacturing sites.
·
Financial Impact: Due to the facility’s high contribution to Alkem’s U.S.
generics business and significant non-backed-up product exposure, prolonged
remediation timelines or regulatory escalation could affect future ANDA
approvals, increase compliance-related expenses, and create supply risk for
high market share products.
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Inspection History:
The facility showed improved compliance
after a 2018 VAI classification, with subsequent NAI outcomes. However, the
latest Form 483 indicates renewed FDA scrutiny at the site.
The Form 483 observations indicate potential compliance concerns related to
manufacturing practices, quality systems, or product safety; however, the
company has committed to addressing all observations within the stipulated
timeline. While no major enforcement action has been initiated, timely
remediation will be important to avoid potential impact on current supply and
future approvals. The recent EU GMP certification from the Malta Medicines
Authority also suggests that the facility maintains acceptable compliance
standards under European regulations.