The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22
The company will respond to these observations within the stipulated time period.
None of the observations are related to data integrity and management believes that they are addressable
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline
Inspection outcome reinforces company's compliance track record and strengthens its ability to serve regulated markets including the United States
18-year veteran Saharsh will position the CDMO as a premier global API process development and commercial manufacturing specialist
The inspection is now closed, and no regulatory action has been recommended
Inspection included drug device combinations covering our recent filing in nasal sprays domain
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