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US FDA bans import from Dr Reddy’s Mexico plant
Having put Dr Reddy’s Laboratories on notice a month back over non-compliance with the good manufacturing practices in Mexico, the US Food and Drug Administration has banned products made at the plant – blocking the sale of products from this facility to the US. In the Warning letter issued last month, the FDA had specified four deviations at Mexico unit. It had asked Dr. Reddy's to determine their cause and prevent them from recurring. The company manufactures intermediates and active pharmaceutical ingredients at this plant. However, the financial impact from this ban is negligible as contribution from the Mexico plant to the overall sales is negligible. The ban remains in effect till the FDA is satisfied with the corrective measures.
Cadila's injectable plant got USFDA Warning letter in pre approval inspection
Cadila has got a warning letter for one of its newly setup facility at Bavla for sterile Injectable. It was a Pre approval inspection by US FDA. There were two objections raised in this warning letter.
n One was in Microbiology area for recording the data and
n Second was in monitoring of microbiological contaminants.
These objections are very minor in nature and can be corrected easily. Current business is not impacted as this plant does not generate any revenues for the company. It was a pre approval inspection for the sterile injectable plant. Cadila has 15 days to notify to the USFDA the steps it has taken to correct the violations.
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