Insulin auto-pen injection manufacturing line at MayMag Biologics GMP facility

506(e) Contract Manufacturer · GMP Certified · Dallas, Texas

Weekly Insulin & Long-Acting Insulin Auto-Pen Injections

MayMag Biologics manufactures biosimilar insulin auto-pen injections under contract for metabolic disease — addressing critical drug shortages with GMP-certified domestic production.

Leading CDMO for Insulin Biosimilar Auto-Pen Manufacturing

MayMag Biologics is a registered 506(e) outsourcing facility and contract development and manufacturing organization (CDMO) specializing in insulin biosimilar auto-pen injections for metabolic disease. Our GMP-certified facilities in Dallas and Garland, Texas, produce once-weekly, ultra-long-acting, basal, and rapid-acting insulin formulations in collaboration with FDA-approved biosimilar API manufacturers.

As insulin shortages continue to affect millions of patients with Type 1 and Type 2 diabetes globally, MayMag Biologics provides a domestic manufacturing solution that reduces healthcare costs, strengthens supply chain resilience, and delivers biosimilar-quality insulin products at commercial scale.

Insulin Formulations

Weekly · 42h · 24h · Rapid

506(e)

Outsourcing Facility

FDA Registered

GMP

Certified Facilities

Dallas & Garland, TX

U-100/U-200

Concentrations Available

Auto-pen & vial formats

Insulin Auto-Pen Products in Shortage — Contract Manufactured by MayMag Biologics

Each product is manufactured as a biosimilar in collaboration with FDA-approved API partners, under GMP-certified conditions at our 506(e) registered facilities.

In Shortage

MayMag Biologics

Insulin Icodec

700 Units/mL (U-700)

Once Weekly · Subcutaneous

Rx Only

Dose

70 U

Starting

Auto-Pen Injector · For Subcutaneous Use Only

Product & Contract Manufacturing

A novel ultra-concentrated once-weekly basal insulin (U-700) designed to maintain stable glycemic control with a single subcutaneous injection per week.

MayMag Biologics manufactures Insulin Icodec biosimilars under 506(e) outsourcing facility registration, providing GMP-compliant fill-finish, auto-pen assembly, and cold-chain packaging for pharmaceutical partners.

Once-Weekly Basal InsulinAwiqli (reference brand)

Insulin Icodec

Dosage Form

Pre-filled auto-pen injection, 3 mL cartridge

Concentration

700 Units/mL (U-700)

Typical Dose

Once weekly; starting dose typically 70 Units (0.1 mL) per week, adjusted to fasting glucose target

Onset of Action

Gradual onset over 24–48 hours

Duration of Action

7 days (once-weekly dosing)

Half-Life

~196 hours (approximately 8 days)

Indication

Glycemic control in adults with Type 1 and Type 2 diabetes mellitus

Mechanism of Action & Clinical Use

Long-acting basal insulin analogue with albumin-binding modification enabling once-weekly subcutaneous administration. Provides steady-state basal insulin coverage throughout the week, reducing injection burden from daily to weekly.

Biosimilar Manufacturing

Manufactured under contract in collaboration with approved biosimilar API manufacturers. Biosimilar insulin icodec offers equivalent glycemic efficacy to the reference product at significantly reduced cost, improving access for patients and healthcare systems globally.

In Shortage

MayMag Biologics

Insulin Degludec

100 Units/mL (U-100) and 200 Units/mL (U-200)

Once Daily · Subcutaneous

Rx Only

Dose

10 U

Starting

Auto-Pen Injector · For Subcutaneous Use Only

Product & Contract Manufacturing

An ultra-long-acting basal insulin analog with a half-life exceeding 25 hours, available in U-100 and U-200 concentrations for flexible once-daily dosing in adults and pediatric patients.

Our Garland, TX GMP facility produces Insulin Degludec biosimilar drug product in prefilled auto-pen format, with full analytical release testing, stability programs, and regulatory documentation support.

Indication

Glycemic control in adults, adolescents, and children aged 1 year and older with Type 1 and Type 2 diabetes mellitus.

Mechanism of Action

Ultra-long-acting basal insulin analogue that forms soluble multi-hexamer chains after subcutaneous injection, creating a subcutaneous depot that slowly releases monomers into circulation. The extended duration of action (up to 42 hours) provides flexible dosing and a flat, stable pharmacokinetic profile with low day-to-day variability.

Biosimilar Manufacturing

Biosimilar insulin degludec is manufactured under contract with approved API partners. The biosimilar formulation delivers equivalent pharmacokinetic and pharmacodynamic profiles to Tresiba at substantially reduced cost, supporting broader patient access.

Ultra-Long-Acting Basal Insulin (up to 42 hours)Tresiba (reference brand)

Insulin Degludec

Dosage Form

Pre-filled FlexTouch auto-pen injection, 3 mL cartridge

Concentration

100 Units/mL (U-100) and 200 Units/mL (U-200)

Typical Dose

Once daily at any time of day; starting dose 10 Units/day for Type 2 diabetes, individualized for Type 1

Onset of Action

Gradual onset; steady state reached after 2–3 days

Duration of Action

Up to 42 hours — the longest-acting basal insulin available

Half-Life

~25 hours

In Shortage

MayMag Biologics

Insulin Detemir / Insulin Glargine

100 Units/mL (U-100)

Once or Twice Daily · Subcutaneous

Rx Only

Dose

10 U

Starting

Auto-Pen Injector · For Subcutaneous Use Only

Product & Contract Manufacturing

Established 24-hour basal insulin analogs offering predictable, peakless glycemic control; available as biosimilar formulations in U-100 concentration for once or twice-daily subcutaneous administration.

MayMag Biologics provides contract manufacturing of Insulin Detemir and Glargine biosimilars, including formulation development, sterile fill-finish, auto-pen device assembly, and ICH-compliant stability testing.

24-Hour Basal InsulinLevemir / Lantus (reference brands)

Insulin Detemir & Insulin Glargine

Dosage Form

Pre-filled auto-pen injection, 3 mL cartridge (FlexPen / SoloStar format)

Concentration

100 Units/mL (U-100)

Typical Dose

Once or twice daily subcutaneous injection; 10 Units/day starting dose for Type 2 diabetes, individualized for Type 1

Onset of Action

1–2 hours after injection

Duration of Action

Up to 24 hours for both formulations

Half-Life

Detemir: ~5–7 hours; Glargine: ~12 hours (both provide ~24-hour duration)

Indication

Glycemic control in adults and children with Type 1 and Type 2 diabetes mellitus

Mechanism of Action & Clinical Use

Insulin detemir is a fatty-acid-acylated basal insulin that binds reversibly to albumin, extending its duration of action to approximately 24 hours. Insulin glargine forms microprecipitates at the injection site after subcutaneous administration, providing a slow, steady release of insulin monomers over 24 hours. Both provide a relatively flat, peakless pharmacokinetic profile suitable for once-daily basal dosing.

Biosimilar Manufacturing

Biosimilar insulin glargine (e.g., Semglee, Rezvoglar) and biosimilar insulin detemir are manufactured under contract with FDA-approved API partners. MayMag Biologics provides fill-finish, lyophilization, and auto-pen assembly services for both biosimilar formulations, reducing the cost of 24-hour basal insulin therapy globally.

In Shortage

MayMag Biologics

Insulin Aspart

100 Units/mL (U-100)

Mealtime · Subcutaneous

Rx Only

Dose

5 U

Starting

Auto-Pen Injector · For Subcutaneous Use Only

Product & Contract Manufacturing

A rapid-acting insulin analog with onset within 10–20 minutes, engineered for mealtime glycemic control and continuous subcutaneous insulin infusion (CSII) pump compatibility.

We offer end-to-end CDMO services for Insulin Aspart biosimilars — from API sourcing through our Gan & Lee and Biocon partnerships to sterile auto-pen fill-finish and labeled device packaging under 506(e) registration.

Indication

Glycemic control in adults and children with Type 1 and Type 2 diabetes mellitus; mealtime (prandial) insulin coverage.

Mechanism of Action

Rapid-acting insulin analogue with a single amino acid substitution (proline to aspartic acid at position B28) that reduces self-association, allowing faster absorption from the subcutaneous injection site compared to regular human insulin. Provides rapid mealtime glucose control with a shorter duration of action, reducing the risk of late postprandial hypoglycemia.

Biosimilar Manufacturing

Biosimilar insulin aspart is manufactured under contract with approved API partners. MayMag Biologics provides aseptic fill-finish and auto-pen assembly for biosimilar insulin aspart, delivering equivalent mealtime glycemic control at reduced cost.

Short-Acting Rapid Mealtime InsulinNovoLog / NovoRapid (reference brand)

Insulin Aspart

Dosage Form

Pre-filled FlexPen auto-pen injection, 3 mL cartridge

Concentration

100 Units/mL (U-100)

Typical Dose

5–10 Units per meal (individualized); inject immediately before or within 20 minutes of starting a meal; can also be used in insulin pumps (CSII)

Onset of Action

10–20 minutes after injection

Duration of Action

3–5 hours

Half-Life

~81 minutes

506(e) Contract Manufacturing

Biosimilar Insulin Manufacturing in Collaboration with Approved API Partners

MayMag Biologics manufactures all four insulin formulations as biosimilars in collaboration with FDA-approved and internationally accredited biosimilar API manufacturers. Our API partners hold regulatory approvals from the FDA, EMA, and WHO Prequalification Programme, ensuring that every biosimilar insulin product meets the same quality, safety, and efficacy standards as the reference brand.

Biosimilar insulin products manufactured by MayMag Biologics are produced under GMP-certified conditions at our Dallas and Garland, Texas facilities. Our 506(e) outsourcing facility registration ensures full FDA oversight and compliance with Current Good Manufacturing Practice (cGMP) regulations for sterile injectable biologics.

By combining domestic US manufacturing with internationally sourced biosimilar APIs, MayMag Biologics delivers insulin auto-pen products that reduce the cost of diabetes care globally — making once-weekly, ultra-long-acting, basal, and rapid-acting insulin therapies accessible to more patients and healthcare systems worldwide.

MayMag Biologics biosimilar insulin manufacturing partnership laboratory

Manufacturing Capabilities

Sterile aseptic fill-finish for insulin vials and cartridges
Auto-pen and pre-filled injector assembly (FlexPen, FlexTouch, SoloStar formats)
Lyophilization for insulin formulations requiring freeze-drying
Cold chain logistics and temperature-controlled storage
Full batch documentation, Certificate of Analysis (CoA), and regulatory submission support
506(e) outsourcing facility registration — full FDA oversight
GMP certification: UAMLS No. INGM/AN-27354/130977/0626 (valid through June 2029)

Partner with MayMag Biologics for Insulin CDMO Services

Contact our team to discuss contract manufacturing for insulin biosimilar auto-pen injections, API sourcing partnerships, or custom formulation development for metabolic disease therapeutics.