cGMP FDA

FDA-Registered 503B Outsourcing Facility & cGMP CDMO

Xseer Pharmaceuticals® is a U.S.-based manufacturing partner bridging healthcare demand and pharmaceutical innovation with uncompromising cGMP compliance.

  • For Clinics & Hospitals: We supply premium, rigorously tested 503B sterile injectables—ensuring a reliable, direct-to-facility supply of "office-use" therapeutics and core wellness protocols.
  • For Biotech & Pharma: Our CDMO services provide end-to-end support—delivering formulation, analytical testing, and commercial-scale manufacturing for sterile injectables, peptides, and other complex formulations.
Sterile Drug Products
Formulation Development
Chewable Innovation
Non-Sterile Products
Clinical Packaging
IV Therapies
Sterile Cosmetic Injection
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Uncompromising Quality & Process Control

At Xseer Pharmaceuticals, compliance is the foundation of our operations. Driven by dedicated Quality Unit oversight and a comprehensive in-house analytical laboratory, we manufacture and supply drug products at scale under strict federal standards. We uphold the highest levels of batch traceability, validated sterility testing and assurance, and aseptic processing—ensuring our partners receive exceptionally safe therapeutics and remain fully inspection-ready.

Advanced In-House Testing Services

Supporting 503A, 503B, and CDMO release and stability testing. By utilizing state-of-the-art rapid detection technology, we eliminate third-party lab delays to deliver faster, safer, and fully compliant therapeutics.

  • BACT/ALERT® 3D: Real Time and Automated Microbial Detection Systems
  • SCANRDI®: rapid microbial detection delivers sterility results in 4 hours or less
  • Charles River Lab EndoSafe MCS: Precision automated endotoxin screening.

Resource Hub

Optimizing Metabolic Protocols: The Synergistic Role of Levocarnitine, L-Arginine, and Active B12

Optimizing Metabolic Protocols: The Synergistic Role of Levocarnitine, L-Arginine, and Active B12

Medical weight management continues to evolve as practitioners seek safe, effective adjunctive therapies to support patients beyond standard diet and exercise r...

Read more Clinical & Technical Insights
Overcoming Formulation Challenges in Sterile Peptide Injectables and Complex Therapeutics

Overcoming Formulation Challenges in Sterile Peptide Injectables and Complex Therapeutics

Peptide therapeutics and complex coenzymes represent one of the fastest-growing sectors in modern medicine. By bridging the gap between small-molecule drugs and...

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FDA Proposes Exclusion of GLP-1s from the 503B Bulks List: Implications for Outsourcing Facilities

FDA Proposes Exclusion of GLP-1s from the 503B Bulks List: Implications for Outsourcing Facilities

The U.S. Food and Drug Administration (FDA) continues to refine the regulatory framework governing compounded medications, introducing significant implications...

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Partner With a CDMO You Can Trust

From formulation to finished product, Xseer is committed to delivering regulatory clarity, technical excellence, and reliable execution.

cGMP

CURRENT GOOD
MANUFACTURING PRACTICE

FDA

FDA 503B
REGISTERED FACILITY