DPT Laboratories, Ltd.
Overview
DPT Laboratories, Ltd. is a contract development and manufacturing organization specializing in semi-solid and liquid dosage forms. The company offers comprehensive services from pharmaceutical development to commercial manufacturing. As a subsidiary of the CMIC Group, DPT serves clients across various therapeutic areas, leveraging decades of industry expertise.
Therapeutic areas
API / Drug Master Files
DPT Laboratories, Ltd. holds 40 active (58 total) FDA Type II Drug Master Files — 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.
- BRIVARACETAMActive2025-03-31
- LOSARTAN POTASSIUM USPActive2024-09-26
- RIVAROXABAN USPActive2024-09-19
- IRBESARTAN USPActive2023-11-07
- TICAGRELORActive2022-01-27
- BSPG CANNABIDIOL (CBD) APIActive2021-05-13
- ORLISTATActive2021-04-30
- LACOSAMIDEActive2021-03-09
- VIGABATRIN USPActive2017-07-29
- PREGABALIN (ALTERNATIVE PROCESS)Active2016-08-01
- LEVETIRACETAM (PROCESS B)Active2016-01-08
- MESALAMINE USPActive2015-11-06
- OLMESARTAN MEDOXOMIL USPActive2014-01-28
- VALSARTAN USPActive2011-03-29
- TRITYL LOSARTANActive2010-09-15
Showing 15 of 58 Drug Master Files.
FDA compliance signals
15 FDA enforcement records linked to this company.
- 4832026-02-10
Control procedures to monitor and validate performance
- 4832026-02-10
Absence of Written Procedures
- 4832018-12-14
Authority lacking to review records, investigate errors
- 4832018-12-14
Written records kept in individual logs
- 4832018-12-14
Identification of Equipment and Lines
- 4832016-08-26
Cleaning / Sanitizing / Maintenance
- 4832016-08-26
SOPs not followed / documented
- 4832016-08-26
Procedures to be written and followed
- 4832014-04-25
Label storage access limited to authorized personnel
- 4832014-04-25
Written procedures not followed
- 4832014-04-25
Complete test data included in records
- 4832014-04-25
Protective Apparel Not Worn
- 4832014-04-25
No written record of investigation
- 4832014-04-25
Scientifically sound laboratory controls
- 4832014-04-25
Written procedures describing in detail
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 14 days.