GMP manufacturing
FDA-Registered GMP Production Facilities
Our Dallas and Garland facilities operate under current Good Manufacturing Practice regulations, ensuring every product meets the highest standards of quality, safety, and consistency.
Regulatory Certifications
FDA 503B Outsourcing Facility
Registered with the US Food & Drug Administration as a 503B outsourcing facility, authorised to produce compounded drugs at commercial scale without patient-specific prescriptions.
USP <797> Sterile Compounding
Full compliance with United States Pharmacopeia Chapter <797> governing sterile compounding, including environmental monitoring, personnel training, and beyond-use dating.
USP <800> Hazardous Drugs
Certified handling of hazardous pharmaceutical compounds under USP <800>, with dedicated negative-pressure rooms, CSTD use, and validated decontamination procedures.
DEA Schedule II–V Licence
Licensed by the Drug Enforcement Administration for the manufacture, storage, and distribution of Schedule II through V controlled substances.
GMP Production Workflow
Raw Material Receipt & Testing
All incoming APIs and excipients undergo identity, purity, and potency testing against USP and in-house specifications before release to production.
Batch Record Issuance
Master batch records are reviewed and approved by QA before each production run. Electronic batch records ensure 21 CFR Part 11 compliance.
Cleanroom Manufacturing
Aseptic processing in ISO 5–7 classified cleanrooms with continuous environmental monitoring, personnel gowning qualification, and media fill validation.
In-Process Controls
Defined in-process tests at critical steps including pH, osmolality, particulate matter, fill weight, and container closure integrity.
QC Release Testing
Finished product testing per USP monographs and in-house specifications. Sterility, endotoxin, potency, and identity testing before any product is released.
Stability Programme
Ongoing ICH-aligned stability studies for all products, with real-time and accelerated conditions. Data supports shelf-life assignment and regulatory submissions.
Our Facilities
Dallas Facility
Dallas, TX
Sterile fill-finish, lyophilisation, QC laboratory
Garland Facility
Garland, TX
Peptide synthesis, API processing, cold chain storage
Audit-ready documentation on request
Request facility qualification packages, SOPs, and quality agreements for your due diligence.
Request Documentation