Last updated: June 1, 2026
ACTOPLUS MET is a fixed-dose combination product containing metformin and pioglitazone. Suppliers and supply-chain participants differ by country, strength, dosage form, and whether the product is marketed under brand name or distributed as authorized generics.
Who manufactures ACTOPLUS MET (metformin + pioglitazone) and supplies the active ingredients?
Core supplier roles split into:
- Active pharmaceutical ingredient (API) manufacturers for metformin and pioglitazone (separate contracts per API).
- Finished dosage form (FDF) manufacturers that blend, granulate, compress, coat, and package tablets.
- Packaging and secondary packaging suppliers (blisters, bottles, cartons, leaflets).
- Market authorization holders and local distributors that source from the FDF plant(s) and manage country-specific labeling.
What to expect in supplier structures for ACTOPLUS MET
- Metformin API is commonly supplied via multiple global qualified sources; pioglitazone API is also multi-sourced, but typically under tighter quality monitoring.
- Tablet manufacturing and packaging are usually performed at a smaller number of contracted FDF sites tied to the specific strengths (and sometimes to country-specific artwork/leaflets).
What companies are the typical supplier and marketing authorization holders for ACTOPLUS MET?
At the brand level, “supplier” can mean one of two things:
- Marketing authorization holder (MAH) in a given jurisdiction, which contracts manufacturing and controls batch release.
- Importer/distributor (sometimes separate from the MAH) that handles customs, warehousing, and sales distribution.
For ACTOPLUS MET, supplier identification requires the country-specific product listing
- The same brand name can have different MAHs and different manufacturing sites across markets.
- Strengths and dosage forms (tablet variants) can map to different FDF plants.
Which finished-dose manufacturing sites produce ACTOPLUS MET tablets?
FDF suppliers are usually identified via:
- Country labeling “manufactured by” lines
- Batch release information in local registration dossiers
- Tender/contract references linked to local distributors
Supply chain reality
- One MAH may use multiple manufacturing plants over time.
- Re-packaging for local market compliance often shifts secondary suppliers even when primary tablet manufacturing stays fixed.
How do suppliers differ by ACTOPLUS MET strength (metformin/ pioglitazone combinations)?
Strength-specific mapping is common
- Tablets with different metformin doses (and different pioglitazone doses) can use different:
- granulation or coating parameters
- tablet core composition
- packaging configurations
Supplier impact
- API sourcing remains tied to the same drug substance unless a site swap is approved.
- FDF sites and packaging lines can change per strength.
What regulatory filings show suppliers for ACTOPLUS MET (Orange Book and foreign equivalents)?
US pathway check (Orange Book)
- If ACTOPLUS MET is not listed as an approved NDA/ANDA product in the US Orange Book for specific strengths, US filings will not provide the same structured supplier roster.
- When a brand is listed, the Orange Book can link:
- applicant/holder
- listed patents (not supplier identity directly)
- sometimes manufacturing site details via label or application summaries
Foreign equivalents
- EU SmPC and national registers, UK registers, and other country portals often list:
- MAH
- manufacturer of the finished product
- batch release site
- manufacturer of API (sometimes)
What is the supplier landscape for metformin (API and FDF inputs) used in ACTOPLUS MET?
Metformin supply chain
- API sources are typically established chemical manufacturers with DMF/CEP support (jurisdiction dependent).
- Downstream blending and tablet formulation suppliers must match:
- particle size and polymorph control
- impurity profiles and residual solvents
- excipient systems aligned to the product’s formulation
Where supply constraints usually appear
- Tight impurity specifications (process-related).
- Changes in supplier leading to regulatory comparability requirements.
What is the supplier landscape for pioglitazone (API and formulation inputs) used in ACTOPLUS MET?
Pioglitazone supply chain
- API is less commonly sourced than metformin in many markets, which can tighten vendor availability.
- FDF manufacturing must manage:
- uniformity of distribution in multi-strength tablets
- dissolution and bioequivalence-maintaining formulation controls
What generic or authorized-supplier substitutions affect ACTOPLUS MET sourcing?
Substitution risk is market-specific
- Where generics exist for metformin + pioglitazone tablets, distributors may switch procurement away from branded ACTOPLUS MET.
- Contract manufacturing may still feed multiple brand labels, but regulatory and labeling constraints differ by MAH and country.
Key Takeaways
- “Suppliers for ACTOPLUS MET” is not a single fixed list. It breaks into API suppliers (metformin, pioglitazone), finished-dose tablet manufacturers, packaging suppliers, and local MAH/distributors.
- Supplier identity is jurisdiction and strength-specific because MAHs and manufacturing sites vary across markets.
- The most reliable supplier mapping comes from the country labeling “manufactured by” and batch release statements and the corresponding national product registers.
FAQs
1) Are metformin and pioglitazone API suppliers the same globally for ACTOPLUS MET?
No. API suppliers vary by country registration, qualification status, and MAH contracting.
2) Does ACTOPLUS MET use one tablet manufacturing plant for all strengths?
Not necessarily. Different strengths can map to different FDF sites and packaging lines.
3) Can I identify ACTOPLUS MET manufacturers from the tablet label?
Yes for finished product and packaging where the label includes “manufactured by” and “marketed by” lines in the relevant jurisdiction.
4) Does the Orange Book list ACTOPLUS MET manufacturing suppliers in the US?
Only if the product is listed with sufficient detail; many brand listings focus on application/patents rather than a complete supplier roster.
5) What changes trigger regulatory re-qualification of ACTOPLUS MET suppliers?
API supplier changes, FDF plant changes, and certain packaging or manufacturing process changes can trigger comparability and post-approval updates depending on jurisdiction and quality system rules.
References
- FDA, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. Food and Drug Administration.
- European Medicines Agency (EMA), product information and public assessment documents for fixed-dose combinations (where applicable).
- WHO, International drug regulatory harmonization guidance on quality/comparability (general principles for supplier changes).
