Zeptide Pharma: Leading the Manufacturing of GLP-1 and GIP Therapeutics
Zeptide Pharma continues to set the industry standard as a premier B2B Contract Development and Manufacturing Organization (CDMO) for metabolic and endocrine therapies. With 25 years of pharmaceutical expertise, Zeptide is a leading manufacturer of approved GLP-1 (Glucagon-like peptide-1) and GIP (Glucose-dependent insulinotropic polypeptide) medications ready for commercial distribution.
To meet diverse patient needs and global supply chain demands, our high-volume manufacturing lines are optimized to produce these critical medications in three distinct delivery formats: next-generation once-a-week oral tablets, patient-friendly auto-injector pens, and traditional sterile vials.
Multi-Format Commercial Capabilities
Zeptide Pharma’s state-of-the-art facilities are designed to handle the complex formulation and fill-finish requirements of peptide-based therapeutics:
- Next-Generation Oral GLP-1/GIP: We are at the forefront of oral peptide delivery, manufacturing tablets that improve patient compliance by eliminating needle anxiety and simplifying logistics by removing strict cold-chain requirements.
- Auto-Injector Pens: Utilizing advanced robotic isolator technology (RABS) and high-speed automated assembly, we produce ready-to-use auto-injectors that ensure precise dosing and ease of use for patients managing chronic conditions.
- Sterile Vials: For clinical settings and specific dosage requirements, our ISO 5 cleanrooms provide nitrogen-blanketed, precision fill-finish operations for sterile vials.
Comprehensive Quality Control and Batch Testing
Because GLP-1 and GIP medications require exact precision to maintain structural integrity and therapeutic efficacy, Zeptide Pharma subjects every single batch to a rigorous, multi-stage Quality Control (QC) process. No product is released for commercial distribution until it passes the following comprehensive testing protocols:
- Raw Material and API Qualification: Before compounding begins, all active pharmaceutical ingredients (APIs) and excipients undergo strict identity, purity, and bioburden testing to ensure they meet exact compendial standards.
- High-Performance Liquid Chromatography (HPLC): Each batch undergoes advanced chromatographic testing to verify the precise concentration (potency) of the GLP-1/GIP peptides and to confirm the absolute absence of impurities or degradation products.
- Sterility and Endotoxin Testing: For all injectable formats (pens and vials), samples are subjected to stringent bacterial endotoxin testing (LAL) and 14-day sterility incubation to guarantee the product is completely free of microbial contamination.
- Container Closure Integrity Testing (CCIT): To ensure the sterile barrier is maintained throughout the product's shelf life, vials and pen cartridges undergo deterministic leak testing. We utilize High-Voltage Leak Detection (HVLD) and vacuum decay methods to identify micro-fissures invisible to the human eye.
- Automated Visual Inspection (AVI): Every single sterile unit passes through an AI-powered, 360-degree high-speed camera system. This system inspects for particulate matter, correct fill volumes, and cosmetic defects in the glass or closures.
- Dissolution Testing (Oral Formulations): For oral GLP-1 and GIP tablets, batches undergo dissolution and disintegration testing to ensure the active ingredients will be released and absorbed at the correct rate within the digestive tract.
- Electronic Batch Record (EBR) Review: Zeptide utilizes a paperless, 21 CFR Part 11 compliant Manufacturing Execution System (MES). The Quality Assurance team reviews the complete digital footprint of the batch—including environmental monitoring data from the SCADA system—before issuing the final Certificate of Analysis (CoA) and authorizing commercial release.
By integrating advanced manufacturing technology with uncompromising quality control, Zeptide Pharma ensures that pharmaceutical brands and government partners receive GLP-1 and GIP medications of the highest possible safety, efficacy, and commercial readiness.
To establish a Professional Partnership:
Contact MayMag Biologics (Formerly Tirzepatide Pharma / Zeptide Pharma)
Partner with a premier USA-based, FDA-registered 503B/506E CDMO and IND facility. As a leading sterile API manufacturer and large-scale industrial supplier, we provide comprehensive manufacturing solutions for a wide range of critical care and specialized therapeutics, including:
- Diabetic Care & Biosimilars: Insulin 70/30 pens, glargine, and advanced biosimilars.
- Injectables & Auto-Pens: Auto-injector medications and epinephrine delivery systems.
- Specialized Treatments: Weight-loss therapies, nasal sprays, and ophthalmic products.
- Essential Preparations: Sterile and bacteriostatic waters.
