MayMag Biologics 506e FDA-Registered Pharma: Sterile Biologics Compounding, Outsourcing, and cGMP Manufacturing
A detailed company profile of MayMag Biologics covering FDA 506(e) registration, cGMP compliance, dual DFW facilities, service categories, and certifications for sterile biologics and biosimilar manufacturing.
Company Basics
| Field | Value |
|---|---|
| Company Name | MayMag Biologics (formerly Tirzepatide Pharma) |
| Website | peptidences.com |
| Phone | 469-334-3372 |
| Address | Dallas, Texas 75201 |
| Year Founded | 2005 |
Company Overview
MayMag Biologics is a Dallas, Texas-based FDA-registered 506(e) outsourcing facility and contract development and manufacturing organization (CDMO) specializing in sterile biologics, FDA-shortlisted drugs, auto-pen fill-finish, peptide API synthesis, sterile injectable compounding, biosimilar drug manufacturing, bacteriostatic water for injection (BWFI), and auto-injection device production.
Operating under cGMP standards (21 CFR Parts 210–211), ISO 13485 certification, and USP Chapter 797 and 800 compliance, MayMag Biologics provides pharmaceutical sponsors, research institutions, compounding pharmacies, and specialty distributors with a fully domestic U.S. supply chain for complex drug products — eliminating dependence on overseas API manufacturers.
Core manufacturing capabilities include:
- Solid-phase peptide synthesis (SPPS) for GLP-1 agonists including tirzepatide and semaglutide analogs
- Large-volume sterile injectable fill-finish
- Biosimilar compounding for insulin analogs and GLP-1/GIP dual agonists
- Bacteriostatic water for injection (BWFI) in multi-dose vials
- Epinephrine auto-injectors, insulin pens, and rheumatoid arthritis autoinjectors
- MDI/DPI inhalation therapeutics
MayMag Biologics operates dual cGMP-certified facilities in the Dallas–Fort Worth metroplex (Dallas and Garland, Texas) and serves clients nationwide.
Service Categories
- Contract Pharmaceutical Manufacturing Services
- Peptide Synthesis Services — Custom Sterile Drug Product Manufacturing
- Biological Drug Manufacturing / Biosimilar CDMO
- Bacteriostatic Water for Injection Manufacturing
- Auto-Injector Device Manufacturing
- Inhalation Drug Product Manufacturing (MDI/DPI)
- API (Active Pharmaceutical Ingredient) Manufacturing
- Fill-Finish Contract Manufacturing
- cGMP Contract Manufacturing
Certifications
| Certification | Status |
|---|---|
| FDA Registered | Confirmed |
| cGMP Compliant (21 CFR Parts 210-211) | Confirmed |
| ISO 13485 GMP Certified | Confirmed |
| USP 797 Compliant | Confirmed |
| USP 800 Compliant | Confirmed |
Facility Locations
| Location | Details |
|---|---|
| Primary | Dallas, Texas (cGMP sterile manufacturing) |
| Secondary | Garland, Texas (API synthesis and QC) |
For RFQ and partnership inquiries, visit peptidences.com/contact.
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