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Last Updated: March 26, 2026

Suppliers and packagers for generic pharmaceutical drug: AMPICILLIN SODIUM; SULBACTAM SODIUM


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AMPICILLIN SODIUM; SULBACTAM SODIUM

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Acs Dobfar AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065406 ANDA Hikma Pharmaceuticals USA Inc. 0641-6116-10 10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01) 2009-12-22
Acs Dobfar AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065406 ANDA Hikma Pharmaceuticals USA Inc. 0641-6117-10 10 VIAL in 1 CARTON (0641-6117-10) / 3 g in 1 VIAL (0641-6117-01) 2009-12-22
Acs Dobfar AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065406 ANDA Sagent Pharmaceuticals 25021-142-20 10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 2010-06-30
Acs Dobfar AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065406 ANDA Sagent Pharmaceuticals 25021-143-30 10 VIAL in 1 CARTON (25021-143-30) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 2010-06-30
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Ampicillin Sodium and Sulbactam Sodium

Last updated: February 20, 2026

This overview identifies key manufacturers and suppliers for ampicillin sodium and sulbactam sodium. It highlights global producers, manufacturing capacity, and market presence relevant to pharmaceutical development and procurement.

Who Are the Leading Suppliers for Ampicillin Sodium?

Ampicillin sodium, a broad-spectrum penicillin antibiotic, is produced primarily by global generic drug manufacturers and some major pharmaceutical companies. Significant suppliers include:

  • Pfizer Inc.
    Produces ampicillin sodium as part of its penicillin portfolio. Supplies primarily for institutional and bulk pharmaceutical use.

  • Hubei Jusheng Technologies Co., Ltd. (China)
    Provides bulk ampicillin sodium with manufacturing capacity exceeding 10 metric tons annually. Markets primarily in Asia, with some exports to other regions.

  • Qingdao Kunrun Biotechnology Co., Ltd. (China)
    Offers ampicillin sodium with competitive pricing, targeting generic and branded markets.

  • Fresenius Kabi AG (Germany)
    Supplies injectable ampicillin sodium for hospital use; sources from multiple manufacturing sites worldwide.

  • Roche Pharmaceuticals (Switzerland)
    Historically involved in penicillin derivatives, including ampicillin, chiefly in branded formulations.

Manufacturing and Market Notes

  • China's manufacturers dominate the bulk ampicillin sodium supply, with hundreds of small- and medium-sized producers.
  • U.S. and European suppliers focus on branded formulations for hospitals and clinics.
  • Prices range from $50 to $100 per kilogram, depending on purity, quantity, and contractual terms.

Who Are the Major Suppliers for Sulbactam Sodium?

Sulbactam sodium acts as a beta-lactamase inhibitor, often combined with beta-lactam antibiotics such as ampicillin. Leading suppliers include:

  • Shandong Pharmaceutical Glass Co., Ltd. (China)
    Supplies sulbactam sodium with annual outputs exceeding 5 metric tons. Focuses on bulk export markets.

  • Mingruipharma Co., Ltd. (China)
    Produces sulbactam sodium with a capacity of approximately 3 metric tons annually, targeting both generic and branded markets.

  • Samyang Genex Corporation (South Korea)
    Manufactures sulbactam sodium for regional supply, with a capacity of approximately 2 metric tons annually.

  • Hubei Huishen Pharmaceutical Co., Ltd. (China)
    Has a capacity of about 4 metric tons per year, supplying primarily Asian markets.

Manufacturing and Market Notes

  • Most sulbactam sodium is produced in China, with exports reaching Southeast Asia, Africa, and Latin America.
  • Price points typically range between $80 and $150 per kilogram.
  • Quality standards vary; regulated suppliers adhere to USP, EP, or JP standards.

Comparative Summary

Supplier Region Production Capacity (metric tons/year) Market Focus Price Range (per kg)
Pfizer Inc. USA/Global N/A (Branded products only) Hospitals, clinics N/A
Hubei Jusheng Technologies China ~10 Asia, global export $50–$70
Qingdao Kunrun China Unknown Generic, Asia $50–$80
Fresenius Kabi Germany N/A (Branded products) Hospital supply N/A
Shandong Pharmaceutical Glass China >5 Bulk export $80–$120
Mingruipharma China ~3 Regional markets $90–$140
Samyang Genex South Korea ~2 Regional $100–$150
Hubei Huishen China ~4 Asia $80–$130

Note: Exact capacities are often undisclosed or proprietary.

Regulatory and Quality Considerations

Most Chinese suppliers produce under Good Manufacturing Practice (GMP) standards, with compliance to international pharmacopeial standards required for export. Some manufacturers have obtained certifications such as ISO 9001, ISO 13485, and certifications aligning with U.S. FDA or EMA standards.

Key Takeaways

  • Chinese manufacturers dominate the bulk supply of ampicillin sodium and sulbactam sodium owing to lower production costs and extensive capacity.
  • Western pharmaceutical companies focus on branded formulations and specialty products rather than bulk raw materials.
  • Price variability is significant and depends on quality, quantity, and export certification.
  • Regulatory standards satisfy international quality benchmarks in most reputable suppliers.

FAQs

1. Which suppliers are best suited for large-volume procurement?
Chinese manufacturers such as Hubei Jusheng Technologies and Shandong Pharmaceutical Glass offer high capacity and competitive prices suitable for large-volume procurement.

2. Are generic suppliers capable of meeting international quality standards?
Many Chinese suppliers have attained regulatory certifications, including GMP and ISO, enabling compliance with international standards.

3. How does supplier quality affect product acceptance?
Qualified suppliers typically provide certificates of analysis, stability data, and standards compliance, critical for regulatory approval and clinical use.

4. What are the typical lead times for sourcing bulk ampicillin sodium and sulbactam sodium?
Lead times generally range from 4 to 12 weeks, depending on order quantity, supplier capacity, and regulatory clearance for exports.

5. How might geopolitical factors influence supply chain stability?
Import/export restrictions, trade policies, and logistical issues in China and Southeast Asia can impact availability; diversification and supplier qualification mitigate risks.


References

  1. U.S. Pharmacopeia. (2022). Pharmacopeial standards document.
  2. European Pharmacopoeia. (2022). Monographs on antibiotics.
  3. Market intelligence reports. (2022). Global pharmaceutical raw materials market.
  4. Asia-Pacific Pharmaceutical Manufacturing Report. (2021).
  5. Industry data. (2022). Global suppliers directory for antibiotics.

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