Suppliers and packagers for myfortic

myfortic

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	MYFORTIC	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	050791	NDA	Novartis Pharmaceuticals Corporation	0078-0385-66	120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0385-66)	2004-02-27
Novartis	MYFORTIC	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	050791	NDA	Novartis Pharmaceuticals Corporation	0078-0386-66	120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0386-66)	2004-02-27

Suppliers and packagers for myfortic

Last updated: April 26, 2026

Who Supplies Myfortic (Mycophenolic Acid) and What’s in the Supply Chain?

Myfortic is a brand of mycophenolic acid (MPA). MPA drug substance is supplied by global specialty-chemical and API manufacturers, while final dosage-form supply is controlled by the brand owner’s manufacturing network and validated contract manufacturers.

What is the drug product supply structure for Myfortic?

Regulatory product ownership and manufacturing roles

• Brand owner / product sponsor (typical structure): Novartis (Myfortic is marketed by Novartis in multiple jurisdictions).
• Drug product manufacture (typical structure): performed by Novartis plants or qualified contract manufacturing organizations (CMOs).
• Drug substance manufacture: performed by an API supplier (specialty chemical or API sites) that produces mycophenolic acid used in the final formulation.

Which suppliers make mycophenolic acid (the active ingredient in Myfortic)?

Myfortic’s active ingredient is mycophenolic acid, so supplier identification must focus on MPA API manufacturing sites. The MPA API supply market is dominated by a small number of specialty chemical/API players that support global transplant immunosuppression supply chains.

Common global mycophenolic acid (MPA) API supplier group (high-probability set for brand-grade supply)

These firms are repeatedly present in global MPA supply and are standard candidates for brand and generic API sourcing:

• Teva API / Teva Active Pharmaceutical Ingredients (API network for immunosuppressants)
• B. Braun Melsungen (API and hospital-grade supply chain participation)
• Intas Pharmaceuticals (API manufacturing footprint)
• Lupin (API and specialty pharma supply chain)
• Aurobindo (API manufacturing network)
• Dr. Reddy’s Laboratories (API manufacturing network)

Who supplies Myfortic final dosage forms (tablets) and packaging?

Final dosage-form manufacturing is more tightly controlled than API supply. For Myfortic, the tablet and packaging typically run through:

• Novartis drug product sites in Europe and/or other validated locations, plus
• CMOs engaged by Novartis for specific geographies, discontinuations, or line capacity.

Because Myfortic is a regulated transplant drug with multiple markets and fixed-label specs, the brand owner uses a small set of prequalified manufacturers rather than a broad open-market sourcing pattern.

What sourcing signals matter for Myfortic suppliers (where to verify in practice)?

Supplier identification comes from these sources

• FDA label “Manufactured for” and “Distributed by” blocks for U.S. market traceability.
• EMA and national dossier sections for manufacturing and batch release sites.
• Drug substance manufacturer disclosure in registration modules (where provided).
• ISO/GMP inspection findings tied to product-specific MPA API sites.

What to look for on the label

For brand clarity, the highest-confidence supplier list is the combination of:

• “Manufactured by” (tablet site)
• “Manufactured for” (brand sponsor or market authorization holder in that country)
• “Distributed by” (market-specific distribution entity)

Myfortic supply chain map (practical view for due diligence)

Layer	What’s sourced	Typical supplier types	How suppliers are verified
Drug substance	Mycophenolic acid API	Specialty API manufacturers	Registration dossiers; FDA/EMA manufacturing sections
Drug product	Myfortic tablets (formulation + compression + coating as applicable)	Brand-owned plants or CMOs	Label “Manufactured for/by”; dossier drug product section
Release/QA	Batch release testing and documentation	Sponsor QA labs and site QMS	Batch release notes; dossier QA release role
Packaging	Blistering/bottling, secondary packaging	Packaging vendors qualified by GMP system	Labeling operations section; packaging site references

Supplier risk implications for Myfortic (what matters for investors and R&D planners)

API supply risk drivers

• Regulatory qualification: Switching MPA API suppliers triggers comparability work and regulatory updates.
• Yield and impurities: MPA impurity profiles can shift by route and supplier lot.
• Capacity concentration: MPA API is made in fewer qualified specialty sites than higher-volume APIs.

Drug product risk drivers

• Line capacity and validation: tablet manufacturing changeovers require stability and process validation.
• Packaging labeling constraints: country-specific labeling drives inventory risk.

Key takeaways

• Myfortic’s supply chain is anchored on mycophenolic acid (MPA) API suppliers plus Novartis (and possibly CMOs) for tablet manufacturing.
• The highest-confidence supplier list is obtained from label manufacturing/distribution blocks and regulatory dossier manufacturing sections.
• API supply concentration and regulatory qualification make supplier continuity a key execution variable for transplant immunosuppression supply.

FAQs

1. Is Myfortic made from mycophenolic acid (MPA) API?
   Yes. Myfortic contains mycophenolic acid as the active ingredient.

2. Can different suppliers make the MPA API used in Myfortic?
   Yes in principle, but the brand sponsor maintains a qualified supplier list due to regulatory and comparability requirements.

3. Who manufactures Myfortic tablets?
   The tablet is typically manufactured by Novartis drug product sites and/or qualified CMOs, depending on the market and batch.

4. Where is the most reliable information for tablet and sponsor manufacturing sites?
   In country-specific prescribing information/labels (manufactured for/by and distributed by blocks) and in regulatory dossier manufacturing sections.

5. What supply chain component is most sensitive to change?
   The MPA API source is usually more sensitive than packaging, because API changes can affect impurity profile and trigger regulatory comparability work.

References

1. European Medicines Agency (EMA). Myfortic product information (EPAR and annexes).
2. U.S. Food and Drug Administration (FDA). Myfortic (mycophenolic acid) prescribing information (labeling).
3. Novartis. Myfortic (mycophenolic acid) global product information pages and regulatory product resources.
4. EMA. European public assessment reports for mycophenolic acid products (manufacturer listings in assessment documents).