This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA
Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of US $512 million for twelve months ending Sep 2022 according to IQVIA
Nifedipine Extended-Release Tablets have an estimated market size of US $56 million for twelve months ending September 2022
Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.
Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients
Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
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