Company Description

MayMag Biologics is a Dallas, Texas-based FDA-registered 506(e) outsourcing facility and full-service contract development and manufacturing organization (CDMO) specializing in peptide API synthesis, sterile injectable compounding, biosimilar drug manufacturing, bacteriostatic water for injection (BWFI), and auto-injection device production.

As a registered 506(e) outsourcing facility under the Drug Quality and Security Act (DQSA), MayMag Biologics operates under direct FDA oversight — distinct from traditional state-regulated compounding pharmacies. This designation enables large-scale sterile drug manufacturing for commercial distributors, hospital systems, and pharmaceutical sponsors nationwide.

Core Manufacturing Capabilities

Insulin Fill-Finish, Glargine, Epinephrine Pens, and Peptide API Synthesis

MayMag Biologics performs solid-phase peptide synthesis (SPPS) for GLP-1 agonists including tirzepatide, semaglutide analogs, and custom peptide sequences at clinical and commercial scale. Our peptide manufacturing capabilities serve pharmaceutical sponsors seeking a domestic U.S. alternative to offshore API suppliers.

Biosimilar Drug Manufacturing

Our biosimilar CDMO services include compounded formulations of insulin analogs, GLP-1/GIP dual agonists, and anti-inflammatory biologics. We manufacture biosimilar products addressing critical national drug shortages under FDA 506(e) outsourcing facility designation.

Sterile Injectable Manufacturing

MayMag Biologics provides fill-finish manufacturing for sterile injectables including prefilled syringes, multi-dose vials, and lyophilized drug products. All sterile manufacturing operations comply with USP Chapter 797 and 800 standards and 21 CFR Parts 210–211.

Bacteriostatic Water for Injection (BWFI)

We manufacture bacteriostatic water for injection (BWFI) in multi-dose vials for use as a diluent in peptide and protein drug reconstitution. BWFI production operates under full cGMP compliance and USP sterility standards.

Auto-Injection Device Manufacturing

MayMag Biologics manufactures epinephrine auto-injectors (EpiPen-equivalent), insulin pens, and rheumatoid arthritis autoinjectors. Our automated auto-injection pen manufacturing line addresses critical domestic supply chain gaps for life-saving emergency medications.

Inhalation Therapeutics

Our inhalation drug product capabilities include metered-dose inhaler (MDI) and dry powder inhaler (DPI) formulation development and fill-finish manufacturing for respiratory therapeutics.

Regulatory Credentials

• FDA-registered 506(e) outsourcing facility (DQSA)
• cGMP compliant — 21 CFR Parts 210–211
• GMP Certified
• ISO 13485 certified
• USP Chapter 797 compliant (sterile compounding)
• USP Chapter 800 compliant (hazardous drug handling)

Facilities

MayMag Biologics operates dual cGMP-certified facilities in the Dallas–Fort Worth metroplex:

Location	Function
Dallas, Texas	Primary sterile manufacturing and fill-finish operations
Garland, Texas	Peptide API synthesis, quality control, and analytical testing

Both facilities are FDA-inspected and operate under continuous quality management systems with full batch record documentation, environmental monitoring, and third-party audit readiness.

Why MayMag Biologics

The U.S. pharmaceutical industry's dependence on overseas API supply chains has created significant risk for patients, sponsors, and healthcare systems. MayMag Biologics was founded to provide a fully domestic, FDA-inspected alternative — combining the regulatory rigor of a 506(e) outsourcing facility with the agility and responsiveness of a specialized CDMO.

For partnership and RFQ inquiries, visit peptidences.com/contact.