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Suppliers and packagers for BACTRIM DS
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BACTRIM DS
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 DS | 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 DS | 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 |
BACTRIM DS suppliers (active ingredient, manufacturers, and supply-chain partners)
BACTRIM DS is the branded fixed-dose oral suspension/tablet regimen containing sulfamethoxazole + trimethoprim. Public supplier visibility is typically split between (1) drug substance (API) producers, (2) finished-dose manufacturers (FDF) that package and label the product, and (3) 3PL/distributors that move inventory to wholesalers. BACTRIM DS supplier lists are not consolidated in a single public database, and the available public record is highly dependent on the specific market (eg, US vs. EU) and the specific presentation (eg, suspension vs. tablets) and strength.
If the goal is to identify “suppliers” for procurement, distribution, or IP diligence, the most defensible, auditable starting point is the product’s FDA “Orange Book” record and FDA “Drugs@FDA” labeling history, which ties the brand to the applicant/holder and often provides manufacturer and labeler references through submission history (and, indirectly, distribution channels).
The sections below outline what is typically verifiable for BACTRIM DS and how to map the supply chain to concrete named entities.
Who manufactures BACTRIM DS (finished-dose supplier and labeler)?
Featured snippet answer: BACTRIM DS’s finished-dose supplier is the NDAs’ listed manufacturer/labeler in FDA Orange Book and Drugs@FDA records for the specific dosage form and strength. The brand is typically marketed by the NDA holder and may have multiple contract manufacturers over time depending on package form and lot history.
Key entities to capture in the labeler/manufacturer chain
- NDA holder / applicant for BACTRIM DS (controls regulatory filings and typically licenses manufacturing)
- Finished-dose manufacturer(s) (tableting/suspension manufacture, filling, packaging, labeling)
- Relabeler/distributor (in some markets, inventory may be distributed under the brand by a separate entity)
How these show up in regulatory records
- Orange Book listing: ties the drug product to the application, and often shows associated manufacturing/testing and product attributes.
- Drugs@FDA label history: supports manufacturer/labeler references contained in product labeling and submission packages.
What companies supply sulfamethoxazole and trimethoprim APIs for BACTRIM DS?
Featured snippet answer: The API supplier universe for sulfamethoxazole and trimethoprim is usually broader than the brand’s finished-dose supplier, with multiple global API plants used across different FDF producers and markets.
Typical API sourcing pattern
- Sulfamethoxazole API is made by specialized antibiotic API manufacturers.
- Trimethoprim API is supplied by separate API producers or integrated sites.
- Finished-dose makers qualify API lots and may use multiple suppliers depending on supply continuity and regulatory status (DMF filings, inspections, and quality agreements).
Where to verify named API suppliers
- FDA DMF association to the NDA (often indirect through submission linkage)
- DMF public indexes (where available)
- For the US market: mapping from NDA components to DMF-listed sites is the most direct path to named API producers.
Which distributors supply BACTRIM DS to US wholesalers and pharmacies?
Featured snippet answer: Distribution to pharmacies is executed through US wholesalers and direct-to-pharmacy channels, typically with 3PL/distributor identities visible through package-level and lot-level data, not through a single static supplier list.
Common distribution structure
- NDA holder or finished-dose manufacturer sells to
- National wholesalers (for retail pharmacy inventory) and/or
- GPO-aligned distribution networks
- In parallel, authorized trading partners may move inventory by region.
Where to identify distributor entities
- Lot/labeler/packaging documents
- Wholesaler ordering and product catalogs
- State licensing records (less standardized for branded products)
What is the BACTRIM DS supply chain for generic-equivalent sulfamethoxazole-trimethoprim products?
Featured snippet answer: The supply chain for BACTRIM DS’s generic equivalents is often segmented differently than for the brand. Generic FDF manufacturers frequently source APIs from a different qualified set and may use alternate packaging and testing sites.
Why the “supplier set” changes
- Contract manufacturers win tenders by region and packaging configuration.
- API sourcing shifts with plant availability, quality agreements, and regulatory outcomes.
- Shelf-life and cold-chain rules do not drive this class as strongly as with biologics, but packaging format and compliance do.
How many suppliers are used for BACTRIM DS in the US market?
Featured snippet answer: The number of suppliers is multi-entity in practice because branded FDF manufacturing commonly shifts across contract sites and packaging runs, even if the NDA holder remains constant. A static count cannot be reliably produced without tying to current lot-specific manufacturer identifiers.
Does BACTRIM DS have multiple manufacturers by dosage form (DS suspension vs. tablets)?
Featured snippet answer: Yes. For sulfamethoxazole-trimethoprim combination products, manufacturers and packaging sites can differ across:
- oral suspension vs tablets
- pediatric dosing configurations vs adult formulations
- different package sizes
In the US, the dosage form and strength matter for locating the correct manufacturer/labeler entries in FDA product records.
Which supplier changes trigger regulatory or supply-risk events for BACTRIM DS?
Featured snippet answer: Supply disruptions typically come from three supplier-change categories:
- API plant qualification lapses or production outages
- FDF site changeovers (equipment validation, batch release backlogs)
- Packaging/label supply constraints (bottles, cartons, inserts, coded NDC labeling)
BACTRIM DS supply: what are the key manufacturing and packaging IP/process constraints?
Featured snippet answer: IP constraints for “supplier” questions usually show up as:
- packaging and formulation patents (process parameters, particle specs, stability)
- method-of-use or manufacturing method patents (less common for simple combination products but possible depending on jurisdiction)
- regulatory exclusivities are typically driven by the reference product’s NDA, not by manufacturing site identities
For procurement and sourcing, the operational barrier is more often quality agreement complexity than patent constraints.
Key Takeaways
- “Suppliers for BACTRIM DS” is not a single entity: the supply chain spans API producers, a finished-dose manufacturer/labeler, and wholesaler/distributors.
- The most defensible method to name finished-dose suppliers is to tie BACTRIM DS to its FDA Orange Book/Drugs@FDA listing for the exact dosage form/strength.
- API supplier naming requires linking the NDA to DMF-associated sites or submission history rather than relying on generic market hearsay.
- Manufacturer identity can change over time and across package configurations, so supplier diligence needs lot-to-manufacturer mapping.
FAQs
- How do I find the current BACTRIM DS manufacturer for a specific NDC code?
- Are sulfamethoxazole and trimethoprim APIs sourced from the same supplier for BACTRIM DS?
- What FDA record links BACTRIM DS to its manufacturing sites most directly?
- Do wholesalers show BACTRIM DS supplier identities on purchase orders or only on product labels?
- What supply bottlenecks are most common for oral sulfamethoxazole-trimethoprim products?
References (APA)
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
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