Drug Approval | November 10, 2024
Granules India’s Unit V facility secures USFDA EIR with NAI status
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
Granules now has a total of 67 ANDA approvals from the USFDA
Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients
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This facility manufactures APIs & formulations of oncology and non-oncology products.
Granules India has reported total income of Rs. 1156.23 crores during the period ended December 31, 2023
Sales in the US region grew well, partially offset by the decline in the LATAM and European regions
API, PFI, and Finished dosages contribute 30%, 15%, and 55% of revenue from operations respectively for Q1FY24
The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
The facility is over 79,000 square feet and is equipped with packaging lines
The company's long-term strategy is on science, technology and innovation and the company's strategy relating to this is on track
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