About MayMag Biologics
Redefining Sterile Pharmaceutical Manufacturing
We are a 506(e)-registered, FDA-compliant industrial biologics manufacturer headquartered in Dallas, Texas — built to solve the world's most critical drug shortage challenges at scale.
Our Mission
To manufacture and distribute high-quality, affordable sterile biologics and biosimilar drugs that address global shortages — with uncompromising compliance, precision, and speed.
Our Story
MayMag Biologics was founded with a singular purpose: to bridge the gap between global demand for life-saving injectable drugs and the manufacturing capacity needed to meet it. Originally operating as Tirzepatide Pharm Corp (dba Zeptide Pharma), we rebranded as MayMag Biologics to reflect our expanded scope and end-to-end sterile manufacturing capabilities.
From our FDA-registered, cGMP-compliant facility in Dallas, Texas, we manufacture insulin analogs, GLP-1/GIP receptor agonists, biosimilar diabetic drugs, sterile glaucoma medications, and a growing portfolio of balance and wellness injectables — all under 506(e) industrial outsourcing designation.
We do not serve retail 503B hospital and clinic compounding markets. Our focus is large-scale industrial production for pharmaceutical distributors, private-label partners, and global healthcare supply chains.
Regulatory Credentials
FDA 506(e) Registration
Registered industrial outsourcing facility under the Drug Quality and Security Act (DQSA)
cGMP Compliance
Full compliance with 21 CFR Parts 210–211 current Good Manufacturing Practice regulations
GMP Certificate of Compliance
Certificate No. INGM/AN-27354/130977/0626 issued by UAMLS — covering Insulin Analogs, GLP-1s, Injectable Biologics, 503B & 506E Sterile Drugs, and Clinical IND
ISO 13485 Certified
Quality management system certified to ISO 13485 for medical device and pharmaceutical manufacturing
USP Chapter 797 Compliant
Sterile compounding operations meet USP 797 standards for pharmaceutical compounding
USP Chapter 800 Compliant
Hazardous drug handling meets USP 800 standards for personnel and environmental safety
What Drives Us
Compliance First
Every batch, every process, every decision is anchored in regulatory rigor. We treat compliance not as a checkbox but as the foundation of patient safety.
Scientific Precision
Our formulation scientists and manufacturing engineers apply exacting standards to every product — from API sourcing through sterile fill-finish and final release.
Global Impact
We manufacture at scale to address FDA drug shortage lists and supply pharmaceutical distributors across North America, Europe, and emerging markets.
Partner-Centric
We operate as a true manufacturing partner — transparent, responsive, and committed to long-term supply reliability for every client we serve.
Ready to Partner with Us?
Whether you need private-label manufacturing, bulk API supply, or a reliable 506(e) production partner, we want to hear from you.
Contact Our Team