Share This Page
Suppliers and packagers for bactrim
✉ Email this page to a colleague
bactrim
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Industries | BACTRIM | sulfamethoxazole; trimethoprim | TABLET;ORAL | 017377 | NDA | Sun Pharmaceutical Industries, Inc | 49708-145-01 | 100 TABLET in 1 BOTTLE, PLASTIC (49708-145-01) | 2004-11-01 |
| Sun Pharm Industries | BACTRIM | sulfamethoxazole; trimethoprim | TABLET;ORAL | 017377 | NDA | Sun Pharmaceutical Industries, Inc | 49708-146-01 | 100 TABLET in 1 BOTTLE, PLASTIC (49708-146-01) | 2004-11-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Who Supplies BACTRIM (Sulfamethoxazole/Trimethoprim) for US and Global Markets?
What companies supply BACTRIM?
BACTRIM is the brand name for sulfamethoxazole + trimethoprim (SMX/TMP). Supply is typically split across (1) brand holders/label owners and (2) manufacturers/packagers across dosage forms, strengths, and markets. In the US, BACTRIM is tied to Bausch Health as the brand owner and US marketing entity (brand history through legacy assets; current labeling is Bausch Health). For manufacturing, the supply chain depends on the finished dosage form and the licensed site(s) used for each product line and strength.
US brand/label owner
- Bausch Health Companies (Bausch Health): US label owner/marketer for BACTRIM products (based on US prescribing information pages and label branding).
Which finished-dosage manufacturers commonly support BACTRIM supply?
For BACTRIM, the most visible supply points in regulatory and labeling ecosystems are:
- Finished dose manufacturers and packagers listed on the product label (for each NDC/strength).
- API producers for SMX and TMP that feed finished-dose plants through contract manufacturing and supply agreements.
In the absence of a single consolidated public list of every manufacturer behind every BACTRIM NDC at any time, the operational way to map “suppliers” is label-based: the US prescribing label identifies the manufacturer/packager for that specific NDC.
What are the core supplier categories behind BACTRIM?
BACTRIM supply typically relies on four vendor types:
- API supplier(s) for:
- Sulfamethoxazole (SMX)
- Trimethoprim (TMP)
- Finished-dose manufacturer(s) for:
- Tablets
- Suspension (oral)
- Packager/releaser aligned with the label’s NDC-specific configuration.
- Logistics and warehousing supporting distribution under the label holder’s quality system.
How does labeling identify the supplier “at the NDC level”?
In US practice, each BACTRIM NDC strength and dosage form carries its own label with:
- Manufacturer name
- Manufacturing/packaging site
- Labeling/quality responsibility
This is the most defensible way to enumerate “suppliers” for the product as supplied into the market, since different strengths and forms can be sourced from different plants.
Practical supplier mapping for BACTRIM: what you should pull
To build a supplier list that is decision-grade (R&D sourcing, contingency planning, or investment diligence), the source of truth is:
- FDA NDC label data for BACTRIM tablets and oral suspension (by strength)
- US Prescribing Information (US label pages for BACTRIM)
- Structured product labeling (SPL) and label sections that show the manufacturer and packager
What suppliers should you treat as critical to continuity?
When assessing “suppliers” for BACTRIM supply risk, the critical path sits with:
- Finished-dose plants that currently hold market authorization for specific NDCs
- API producers for SMX and TMP that can sustain lead times under demand surges
SMX and TMP are both commoditized APIs, but finished-dose manufacturing remains the bottleneck when specific NDCs are constrained by equipment, filling lines, or inspection status.
How to interpret “supplier” in procurement terms
There are three distinct procurement models:
- Contract finished-dose manufacturing: the API is supplied by an API vendor or co-supplied under a managed program, and the finished-dose firm blends, fills, packs, and releases.
- Co-manufacturing and co-packaging: one firm manufactures tablets/suspension; another packages and releases under a label’s configuration.
- Distributor-only: distribution partners do not manufacture and are not substitute suppliers in regulatory quality terms.
BACTRIM procurement due diligence should prioritize manufacturer/packager and API origin rather than downstream distributors.
Key BACTRIM supplier landscape (actionable view)
1) Label owner / marketing entity
- Bausch Health (US brand label owner/marketer)
2) Finished-dose and packager manufacturers
- Varies by dosage form and strength and is defined per NDC label.
- Use the manufacturer and packager name(s) printed on the label for each strength and formulation.
3) API supply
- Sulfamethoxazole API
- Trimethoprim API
- API supplier identification requires pulling API vendor disclosure via:
- finished-dose DMF references (where accessible),
- label/manufacturer statements,
- and/or submissions crosswalks in FDA systems (when available).
What sources document BACTRIM supply and manufacturers?
The most reliable public sources for manufacturer names tied to specific NDCs are:
- FDA drug labels (structured labeling and label text)
- DailyMed mirrors label and NDC-specific details including manufacturer and packager in many cases.
These sources let you compile a supplier table by:
- dosage form (tablet vs suspension),
- strength,
- NDC,
- and label manufacturer/packager.
Key Takeaways
- BACTRIM’s “suppliers” split into label owner/marketer (Bausch Health in the US), plus finished-dose manufacturer/packager that varies by NDC/strength.
- The decision-grade supplier list is NDC-label based: use the printed label manufacturer/packager name(s) for each tablet and suspension strength.
- API sourcing (SMX and TMP) is the second tier of supplier mapping and is typically harder to enumerate publicly without DMF-level crosswalks, so finished-dose sites remain the primary continuity risk in real-world supply.
FAQs
Who owns the BACTRIM brand in the US?
- Bausch Health is the US label owner/marketer for BACTRIM products.
Are the BACTRIM tablet and suspension suppliers the same?
- Not necessarily. The manufacturer and packager can differ by dosage form and strength, so supplier identity is NDC-specific.
Where can I find the manufacturer/packager name for a specific BACTRIM NDC?
- On the US label (and its mirrored versions such as DailyMed) that lists the manufacturer/packager for that NDC/strength.
Who supplies the active ingredients in BACTRIM (SMX and TMP)?
- Sulfamethoxazole and trimethoprim API suppliers feed finished-dose manufacturers. Public identification is often not consolidated; finished-dose labels and regulatory filings are the main pathways.
Why does supplier identification change over time?
- BACTRIM supply can shift among licensed manufacturers due to contracting, plant capacity, inspections, and regulatory status, so the label’s current NDC configuration is what matters.
References
[1] DailyMed. BACTRIM (sulfamethoxazole and trimethoprim) prescribing information and product label content. https://dailymed.nlm.nih.gov/
[2] U.S. Food and Drug Administration (FDA). Drug labels and structured product labeling (SPL) for BACTRIM (sulfamethoxazole and trimethoprim). https://www.accessdata.fda.gov/
More… ↓
