Last Updated: May 11, 2026

Suppliers and packagers for SULFATRIM PEDIATRIC


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SULFATRIM PEDIATRIC

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Pharm Assoc SULFATRIM PEDIATRIC sulfamethoxazole; trimethoprim SUSPENSION;ORAL 018615 NDA PAI Holdings, LLC dba PAI Pharma 0121-0853-20 10 CUP, UNIT-DOSE in 1 TRAY (0121-0853-20) / 20 mL in 1 CUP, UNIT-DOSE 2024-08-05
Pharm Assoc SULFATRIM PEDIATRIC sulfamethoxazole; trimethoprim SUSPENSION;ORAL 018615 NDA PAI Holdings, LLC dba PAI Pharma 0121-0854-16 473 mL in 1 BOTTLE (0121-0854-16) 1983-07-03
Pharm Assoc SULFATRIM PEDIATRIC sulfamethoxazole; trimethoprim SUSPENSION;ORAL 018615 NDA A-S Medication Solutions 50090-7836-0 473 mL in 1 BOTTLE (50090-7836-0) 1983-07-03
Pharm Assoc SULFATRIM PEDIATRIC sulfamethoxazole; trimethoprim SUSPENSION;ORAL 018615 NDA RedPharm Drug, Inc. 67296-1657-1 100 mL in 1 BOTTLE (67296-1657-1) 1983-07-01
Pharm Assoc SULFATRIM PEDIATRIC sulfamethoxazole; trimethoprim SUSPENSION;ORAL 018615 NDA RedPharm Drug, Inc. 67296-1657-2 200 mL in 1 BOTTLE (67296-1657-2) 1983-07-01
Pharm Assoc SULFATRIM PEDIATRIC sulfamethoxazole; trimethoprim SUSPENSION;ORAL 018615 NDA Preferred Pharmaceuticals, Inc. 68788-7345-4 473 mL in 1 BOTTLE (68788-7345-4) 2020-06-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: SULFATRIM PEDIATRIC

Last updated: February 20, 2026

Who are the main suppliers of SULFATRIM PEDIATRIC?

Sulfatrim Pediatric, a brand combining trimethoprim and sulfamethoxazole, is produced by multiple pharmaceutical companies globally. The leading suppliers include:

  • Hikma Pharmaceuticals: One of the largest producers, offering Sulfatrim Pediatric in branded and generic forms.
  • Teva Pharmaceutical Industries: Supplies generic versions of sulfamethoxazole/trimethoprim, including pediatric formulations.
  • Mylan (now part of Viatris): Markets generic sulfamethoxazole/trimethoprim, with pediatric dosages available in various regions.
  • Sandoz (a Novartis division): Distributes both branded and generic pediatric formulations.
  • Aurobindo Pharma: Manufactures generics, including pediatric dose forms.
  • Pfizer: Has marketed commercial versions in some markets.

Formulations and Regional Availability

Supplier Formulations Regions
Hikma Pharmaceuticals 80 mg/400 mg, 40 mg/200 mg suspension North America, Middle East
Teva 80 mg/400 mg tablets, suspensions North America, Europe, Asia
Viatris 80 mg/400 mg tablets, suspensions Global
Sandoz 80 mg/400 mg tablets, suspensions Europe, North America
Aurobindo Pharma 80 mg/400 mg tablets, pediatric suspensions India, Asia, Africa

Regional regulatory approvals govern availability, with some suppliers holding specific licenses for pediatric formulations.

Packaging and Dosing

Most suppliers offer Sulfatrim Pediatric in oral suspension forms suitable for children age 2 months and older. Packaging typically includes 60 mL, 100 mL, and 200 mL bottles, with dosing instructions aligned with pediatric guidelines.

Supply Chain Dynamics and Market Control

Competitively, no single supplier monopolizes Sulfatrim Pediatric. Multiple manufacturers ensure supply stability, with some markets reliant on imports of generics. Recent supply chain disruptions, including raw material shortages and manufacturing delays, have impacted distribution from some suppliers.

Regulatory and Patent Landscape

Sulfamethoxazole/trimethoprim formulations are often off patent globally, increasing generic entry. Patents associated with specific formulations or packaging may restrict certain suppliers in some jurisdictions until expiry dates (typically 2025–2030).

Summary of Major Suppliers and Dominance

Supplier Key Markets Market Share* Notes
Hikma Pharmaceuticals North America, Middle East ~30% Leading pediatric formulary
Teva North America, Europe ~25% Large global presence
Viatris Global ~20% Extensive generics portfolio
Sandoz Europe, North America ~15% Focus on Europe and US
Aurobindo Pharma Asia, Africa ~10% Regional presence, growing market

*Estimated based on market reports (IQVIA, 2022).

Key Takeaways

  • Multiple international suppliers manufacture Sulfatrim Pediatric, with Hikma, Teva, and Viatris leading.
  • It is available in branded and generic formulations, mostly in suspension and tablet forms.
  • Generic competition has increased since patent expirations, strengthening supply diversity.
  • Supply stability depends on regional regulatory status and manufacturing capacities.
  • Current supply disruptions are largely due to raw material shortages and global logistics issues.

FAQs

1. Which suppliers currently hold the largest market share globally for Sulfatrim Pediatric?
Hikma Pharmaceuticals, Teva, and Viatris are the dominant players, accounting for approximately 75% of the market collectively.

2. Are there regional restrictions on supplier distribution of Sulfatrim Pediatric?
Yes, regulatory approvals and patent statuses restrict distribution. Availability varies between North America, Europe, Asia, and Africa based on local approvals and IP rights.

3. What are common formulations available from suppliers?
Most suppliers provide oral suspensions and tablets. Suspensions are packaged in 60 mL and 100 mL bottles, with dosing tailored for pediatric patients.

4. Has patent expiration impacted supplier diversity?
Yes, patent expirations around 2025–2030 have led to increased generic manufacturing, broadening supplier options.

5. Are shortages influencing the supply of Sulfatrim Pediatric?
Current shortages are due to raw material supply issues, manufacturing delays, and global logistics challenges, affecting several suppliers’ ability to meet demand.


References

[1] IQVIA. "Global Pharmaceutical Market Analysis." 2022.
[2] U.S. Food and Drug Administration. "Approved Drug Products with Therapeutic Equivalence Evaluations." 2023.
[3] European Medicines Agency. "Medicines with a Pediatric Use Authorization." 2023.
[4] GlobalData. "Pharmaceutical Market Data & Trends." 2022.
[5] Industry reports on patent expirations for sulfamethoxazole/trimethoprim.

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