FDA-Approved CMO for Biologic Drug-Device Combinations and 506e Outsourcing Facility for FDA Drug Shortage Lists and Sterile Biologic Injections by MayMag - FDA Registered 506e Pharma

 

What sets MayMag Biologis(Formerly Tirzepatide Pharam) apart from other 506e pharmas? 

  • We are local, based in the United States, with drug quality controlled and monitored.
  • We have the scale, facility redundancy, and device supply chain to meet 100% of your market demand without a single day of backorder, with multiple FDA-compliant, GMP-certified facilities for both the active drug substance and the "fill-finish" final step. 
  • We understand how to handle the stability requirements of large batches, from formulation through transportation, without risking product degradation
  •  MayMag maintains device continuity assurance with in-house 510k auto device pen manufacturing, clean FDA Form 483 records, and zero warning letters.

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Operating as an advanced Investigational New Drug (IND) facility, Zeptide Pharma stands at the forefront of pharmaceutical innovation, actively developing biosimilar generics and cutting-edge Oral GLP-1 therapeutics. Our robust manufacturing infrastructure is engineered for scale, seamlessly producing insulin pens, nasal sprays, advanced weight-loss treatments, and specialized ophthalmology products for international markets.

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Our Core Specialties

  • Targeted Therapeutics: Peptides (Sterile & RUOs), Insulin analogs, and repurposed insulin.
  • Pharmaceutical Manufacturing: Generic Medicines (OSDs) and specialized Derma-Products.
  • Advanced Delivery Systems: Transdermal Drug Delivery and Investigational New Drugs (INDs).
  • Custom Synthesis & Purification: Expert in-house HPLC drug purification, alongside the specialized synthesis of Custom Peptides, DNA, Oligonucleotides, Wellness Peptides, RNA, and human APIs.

Dedicated B2B Partnership: Zeptide Pharma is strictly a Business-to-Business (B2B) enterprise, designed to support large-scale supply chains. We exclusively serve commercial healthcare distributors and provide specialized generic drug manufacturing services for government awardees. To maintain our operational scale and regulatory focus, we do not provide services or products directly to individuals, private clinics, or hospitals.

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Why Choose Our Pharma-Grade Oligonucleotides?

To rank as a leader in nucleic acid therapeutics, we prioritize quality and compliance at every step:

  • ISO-Certified & cGMP Compliant: Our processes adhere to strict global regulatory guidelines to ensure safety and efficacy for human clinical trials.
  • Advanced Purification: We use high-performance HPLC and Ultrafiltration to ensure maximum purity and the removal of truncated sequences.
  • Comprehensive Analytical Testing: Every batch undergoes rigorous Mass Spectrometry (MS), Capillary Electrophoresis (CE), and endotoxin testing.
  • Full Documentation Support: We provide complete Chemistry, Manufacturing, and Controls (CMC) documentation to streamline your IND (Investigational New Drug) applications.

World Health Organization Global Reach & Regulatory Excellence

We facilitate the cGMP manufacture and global supply of finished drug products to premier markets, including North America, Europe, Asia, and the Middle East. Our commitment to compliance is validated by a flawless track record of inspections from the world’s most stringent global regulatory authorities, including:

  • USFDA, MHRA (UK), & Health Canada
  • ANVISA (Brazil) & PMDA (Japan)
  • PIC/S, GMP, TFDA, and the Gulf Cooperation Council (GCC)

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