Alvogen, Inc.
Overview
Alvogen, Inc. is a global pharmaceutical company that specializes in the development, manufacturing, and marketing of generic, brand, and over-the-counter products. The company has a broad global footprint and focuses on delivering high-quality medications with a diverse portfolio across many therapeutic areas.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Alvogen, Inc. is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
Alvogen, Inc. holds 1 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- PYRIMETHAMINEActive2019-05-28
FDA compliance signals
25 FDA enforcement records linked to this company.
- recall — Class II2026-01-21
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
- recall — Class I2025-02-26
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
- recall — Class II2023-03-08
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
- recall — Class II2021-07-14
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
- 4832021-06-10
Failure to comply with REMS Implementation System
- 4832020-09-11
Late submission of 15-day report
- 4832020-09-11
Failure to develop written procedures
- 4832020-09-11
Interval
- recall — Class II2019-08-21
Failed dissolution specifications
- recall — Class II2019-08-21
Failed dissolution specifications
- recall — Class I2019-05-15
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
- recall — Class II2017-07-12
Lack of Assurance of Sterility
- recall — Class II2017-07-12
Lack of Assurance of Sterility
- recall — Class II2017-07-12
Lack of Assurance of Sterility
- recall — Class III2017-04-12
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
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