MayMag Biologics, formerly known as Tirzepatide Pharma, today announced a comprehensive expansion of its contract development and manufacturing operations. Operating as a premier Dallas, Texas pharmaceutical manufacturer, MayMag Biologics combines the agility of a 506e outsourcing facility with the comprehensive scale of a cGMP contract manufacturer, delivering high-quality, domestic solutions for complex biologics, peptides, and sterile fill-finish operations.

As demand surges globally for metabolic therapies, complex biologics, and reliable supply chains, MayMag Biologics stands out as a unique, single-source partner serving pharmaceutical developers, healthcare providers, and clinical institutions across North America and worldwide.

End-to-End Capabilities: From API to Finished Auto-Injectors

MayMag Biologics offers an integrated suite of development and commercial manufacturing services across multiple critical therapeutic categories:

GLP-1 & Peptide Excellence: As a registered 506(e) outsourcing facility, MayMag Biologics manufactures GLP-1 agonists including tirzepatide and semaglutide analogs at clinical and commercial scale. Our solid-phase peptide synthesis (SPPS) capabilities support both domestic pharmaceutical sponsors and international partners seeking a reliable U.S.-based API source.

Sterile Fill-Finish Manufacturing: Our state-of-the-art sterile manufacturing suites support prefilled syringes, multi-dose vials, lyophilized drug products, and auto-injector pen assembly. All operations comply with USP Chapter 797 and 800 standards and 21 CFR Parts 210–211.

Biosimilar Drug Manufacturing: MayMag Biologics provides biosimilar CDMO services for insulin analogs, GLP-1/GIP dual agonists, and anti-inflammatory biologics — addressing critical national drug shortages under FDA 506(e) outsourcing facility designation.

Auto-Injection Device Manufacturing: From epinephrine auto-injectors (EpiPen-equivalent) to insulin pens and rheumatoid arthritis autoinjectors, our automated assembly lines address critical domestic supply chain gaps for life-saving emergency medications.

Bacteriostatic Water for Injection (BWFI): We manufacture BWFI in multi-dose vials for use as a diluent in peptide and protein drug reconstitution, operating under full cGMP compliance and USP sterility standards.

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

MayMag Biologics operates under the most rigorous regulatory standards in the industry:

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

Dual-Facility Operations in Dallas–Fort Worth

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

• 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.

A Domestic Alternative for a Global Challenge

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.