FAQ — MayMag Biologics Biosimilar Manufacturing

Question 1

What is MayMag Biologics and what does it do?

Accepted Answer

MayMag Biologics (formerly Tirzepatide Pharma / Zeptide Pharma) is a US-based 506(e) industrial pharmaceutical manufacturer specialising in large-scale production of FDA-shortlisted generic drugs and biosimilar biologics. We are not a retail 503b compounder for hospitals or clinics — we manufacture at commercial scale for distributors. We rank as the No. 5 top insulin pen manufacturer in the USA.

Question 2

What is the difference between a 506(e) manufacturer and a 503b compounder?

Accepted Answer

A 503b outsourcing facility compounds drugs for patient-specific or hospital use in smaller batches. A 506(e) manufacturer like MayMag Biologics operates at industrial scale, producing large commercial quantities of FDA-shortlisted generic drugs and biosimilar biologics for distribution. Our operations are subject to full cGMP requirements and FDA oversight equivalent to a traditional pharmaceutical manufacturer.

Question 3

Why is MayMag Biologics rebranding from Tirzepatide Pharma?

Accepted Answer

Effective Q1 2027, our company — formerly known as Zeptide Pharma and operating under the name Tirzepatide Pharma — will officially rebrand as MayMag Biologics. The new name better reflects our expanded biologics portfolio beyond tirzepatide, including insulin pens, rheumatoid auto-injectors, inhalation therapeutics, and bacteriostatic water for injection.

Question 4

Where are your manufacturing facilities located?

Accepted Answer

All our facilities are located in the United States. We maintain multiple FDA-compliant, GMP-certified facilities covering both active drug substance (API) synthesis and fill-finish final steps. Being US-based means drug quality is controlled and monitored under FDA oversight, with no overseas logistics risk.

Question 5

What is an interchangeable biosimilar?

Accepted Answer

An interchangeable biosimilar is a biological medicine that has been shown to be highly similar to its FDA-approved reference product, with no clinically meaningful differences in safety or effectiveness. Crucially, an interchangeable biosimilar can be substituted for its brand-name original right at the pharmacy counter without needing permission from the prescribing doctor — just like a generic substitution for a small-molecule drug.

Question 6

Which GLP-1 biosimilars does MayMag Biologics manufacture?

Accepted Answer

Our GLP-1 biosimilar portfolio includes Tirzepatide, Semaglutide, Cagrillintide, and Retatrutide. We manufacture both the active drug substance (API) and handle fill-finish under one roof, ensuring full chain-of-custody quality control from synthesis through to the final sterile injectable product.

Question 7

How do you ensure GLP-1 product stability at large batch scale?

Accepted Answer

We have deep expertise in handling the stability requirements of large batches — from formulation through transportation — without risking product degradation. Our formulation scientists work within validated cold-chain protocols, and every batch undergoes our eight-step quality control framework before release. Multiple facility redundancy means no single point of failure in the supply chain.

Question 8

Are your GLP-1 biosimilars on the FDA shortage list?

Accepted Answer

We manufacture exclusively for FDA-shortlisted drugs and biosimilar biologics. Our production is aligned with the FDA's current shortage designations, which is the legal basis for 506(e) large-scale manufacturing. Contact us to discuss specific molecules and current availability.

Question 9

What insulin delivery devices does MayMag Biologics manufacture?

Accepted Answer

We manufacture insulin pen injectors, Epinephrine pens, and rheumatoid arthritis auto-injectors (including Adalimumab and Etanercept biosimilar auto-injectors). We hold in-house 510k auto device pen manufacturing capability, which gives us full device continuity assurance — we are not dependent on third-party device suppliers.

Question 10

What makes your auto-injector manufacturing different from competitors?

Accepted Answer

Most biosimilar manufacturers source their delivery devices from external suppliers, creating a second supply chain vulnerability. MayMag Biologics manufactures its auto-injector pens in-house under 510k clearance. We maintain clean FDA Form 483 records and zero warning letters on our device manufacturing lines, and our device supply chain is sized to meet 100% of market demand without backorder.

Question 11

Can you manufacture custom auto-injector configurations?

Accepted Answer

Yes. We offer customisable auto-injector drug delivery for commercial partners. This includes custom dose volumes, needle configurations, and labelling. Contact our CDMO partnerships team to discuss your specific requirements and to review our device customisation capabilities.

Question 12

Do you manufacture Epinephrine pens (EpiPen biosimilars)?

Accepted Answer

Yes. Epinephrine auto-injectors are part of our sterile injectable biologics portfolio. We manufacture at commercial scale with full GMP compliance and device continuity assurance. Our Epinephrine pen production is designed to address the chronic supply shortages that have affected this critical emergency medication.

Question 13

What regulatory certifications does MayMag Biologics hold?

Accepted Answer

Our facilities are cGMP compliant, FDA-registered 506(e) outsourcing facilities, ISO certified, ISO 13485 certified, and USP <797> and <800> compliant. We maintain clean FDA Form 483 records with zero warning letters across all our manufacturing lines. FDA credentials are available for download — contact us to request them.

Question 14

What does your quality control process look like?

Accepted Answer

Every batch passes through our eight-step Quality Control Assurance Framework, which covers raw material testing, in-process checks at critical manufacturing steps, environmental monitoring, sterility testing, potency assays, container closure integrity testing, final release testing, and stability programme monitoring. No batch ships without full QC sign-off.

Question 15

How can I validate your FDA credentials?

Accepted Answer

We welcome credential validation requests from prospective partners and distributors. Contact us via our enquiry form or email cdmo@tirzepatidepharm.com and our regulatory affairs team will provide the relevant FDA registration numbers, GMP certificates, and Form 483 records for your due diligence review.

Question 16

Are your products manufactured in the USA or overseas?

Accepted Answer

100% US-based. All manufacturing — from active drug substance synthesis through fill-finish — takes place in our US facilities. This is a deliberate strategic choice to eliminate the overseas supply chain vulnerabilities that have caused repeated biosimilar shortages in the American market.

Question 17

Who are your typical customers?

Accepted Answer

Our primary customers are commercial distributors, wholesalers, and large healthcare networks that require reliable, large-scale supply of biosimilar biologics and generic injectables. We do not sell directly to hospitals, clinics, or individual patients — our minimum order quantities are sized for commercial distribution.

Question 18

How do I start a partnership with MayMag Biologics?

Accepted Answer

The first step is to reach out via our contact form or email us at info@tirzepatide.us or cdmo@tirzepatidepharm.com. Our business development team will schedule an introductory call, share our current product availability and pricing, and guide you through the credential validation and supply agreement process.

Question 19

Can you guarantee no backorders?

Accepted Answer

Yes — this is a core commitment. We maintain facility redundancy and a device supply chain sized to meet 100% of your market demand without a single day of backorder. Multiple GMP-certified facilities for both API and fill-finish mean that a single facility issue does not interrupt supply. This domestic redundancy is the primary reason distributors choose MayMag Biologics over overseas alternatives.

Question 20

Do you offer CDMO services for other pharmaceutical companies?

Accepted Answer

Yes. We offer contract development and manufacturing (CDMO) services for FDA-shortlisted drugs, including custom peptide synthesis, formulation development, and industrial-scale fill-finish. Contact our CDMO partnerships team at cdmo@tirzepatidepharm.com to discuss your project requirements.

Your Questions Answered

About MayMag Biologics

GLP-1 Biosimilars

Insulin Delivery & Auto-Injectors

Quality, Compliance & Regulatory

Partnering & Ordering

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