Strides Pharma Science has received a warning letter from the United States Food & Drug Administration (USFDA) relating to Puducherry facility. Puducherry site currently produces 6 ANDAs which will not get impacted by the current development. However, the 10 ANDAs pending approval from the site will get deferred till the site is reclassified.
The company is committed to the highest standards of quality and compliance and will work collaboratively with the FDA to resolve all issues addressed in the warning letter. The company retains its growth guidance for the US market.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.
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| Lupin | 2324.25 |
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