Suppliers and packagers for unasyn

unasyn

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	UNASYN	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	050608	NDA	Roerig	0049-0013-83	10 VIAL in 1 CARTON (0049-0013-83) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0013-81)	1991-11-22
Pfizer	UNASYN	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	050608	NDA	Roerig	0049-0014-83	10 VIAL in 1 CARTON (0049-0014-83) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0014-81)	1991-11-22
Pfizer	UNASYN	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	050608	NDA	Roerig	0049-0024-28	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0049-0024-28) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE	1991-11-22

UNASYN Pharmaceutical Drug Suppliers

Last updated: February 19, 2026

This report identifies key suppliers for UNASYN, an antibiotic. Data focuses on manufacturing capabilities, geographical presence, and regulatory compliance relevant to pharmaceutical ingredient production.

Who are the Primary Manufacturers of UNASYN?

The active pharmaceutical ingredients (APIs) for UNASYN, a combination of ampicillin and sulbactam, are manufactured by a limited number of specialized pharmaceutical chemical companies. These entities possess the necessary expertise in complex organic synthesis and adhere to stringent Good Manufacturing Practices (GMP).

Key manufacturers include:

• Sichuan Kelun Pharmaceutical Co., Ltd.

  • This Chinese pharmaceutical company is a significant producer of ampicillin and sulbactam.
  • Kelun has a broad portfolio of APIs and finished dosage forms, serving both domestic and international markets.
  • Their facilities are audited by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
  • Specific manufacturing sites for UNASYN APIs are located in Sichuan Province, China.

• Astron Pharma

  • Astron Pharma, based in India, is another established supplier of antibiotic APIs.
  • They produce both ampicillin and sulbactam, meeting international quality standards.
  • Astron Pharma's operations are certified by regulatory authorities, including compliance with EU GMP.
  • Production facilities are situated in India.

• Divi's Laboratories Limited

  • While primarily known for other APIs, Divi's Laboratories has been involved in the supply chain for ampicillin.
  • Their large-scale manufacturing capabilities and strong regulatory track record make them a potential supplier for components of UNASYN.
  • Divi's operates multiple GMP-compliant facilities in India.

• Other Contract Manufacturing Organizations (CMOs)

  • Several CMOs globally may produce ampicillin and sulbactam intermediates or the final APIs under contract for pharmaceutical companies marketing UNASYN. These include companies in Europe and North America, though specific names are often proprietary information tied to supply agreements.

What are the Key Raw Materials and Their Sources?

The synthesis of ampicillin and sulbactam requires specific precursor chemicals. The availability and consistent quality of these raw materials are critical for UNASYN production.

Ampicillin Synthesis Raw Materials:

• 6-Aminopenicillanic Acid (6-APA): This is the core penicillin nucleus. It is primarily derived from fermentation processes using Penicillium chrysogenum.

  • Major global producers of 6-APA include companies in China, India, and some European countries. Examples include:
    • Biocon Ltd. (India): A significant producer of fermentation-derived APIs, including 6-APA.
    • Fermenta Biotech Ltd. (India): Also a key player in penicillin derivatives.
    • Various Chinese manufacturers: China dominates global 6-APA production capacity.

• Phenylglycine derivatives: Typically D-(-)-α-phenylglycine or its ester. This side chain is attached to the 6-APA nucleus.

  • Sources are specialized chemical manufacturers.
  • Companies in China and India are major suppliers.

Sulbactam Synthesis Raw Materials:

• Penicillin G or other Penicillin G salts: Sulbactam is a penicillanic acid sulfone, synthesized from penicillin G.

  • Penicillin G is also produced via fermentation.
  • Suppliers are similar to those of 6-APA, often integrated operations.

• Oxidizing agents and reagents: Such as m-chloroperoxybenzoic acid (m-CPBA) or other peroxy acids, and various solvents and catalysts.

  • These are commodity and specialty chemicals sourced from global chemical distributors and manufacturers.

The supply chain for these raw materials is complex, with potential single points of failure. Geopolitical factors and stringent quality control at each stage are vital for securing a reliable supply of UNASYN.

Which Countries are Dominant in API Manufacturing for UNASYN?

The production of APIs for UNASYN, particularly ampicillin and sulbactam, is concentrated in specific regions due to cost advantages, established chemical infrastructure, and expertise in pharmaceutical synthesis.

• China: Is the leading country for the production of both ampicillin and sulbactam APIs. Numerous Chinese pharmaceutical chemical companies possess large-scale manufacturing facilities and have achieved regulatory approvals from major health authorities globally.

  • Dominant in 6-APA production.
  • Significant volume of ampicillin and sulbactam API output.

• India: Is the second-largest global supplier of APIs for UNASYN. Indian pharmaceutical companies have strong manufacturing capabilities, a skilled workforce, and a significant presence in the global generics market.

  • A major producer of 6-APA and finished ampicillin/sulbactam APIs.
  • Strong regulatory compliance track record.

• Europe: While not at the same volume as China or India, some European countries have specialized manufacturers producing high-quality APIs, often focusing on niche or high-potency compounds. However, for commodity antibiotics like ampicillin and sulbactam, large-scale production is less common.

• North America: Similar to Europe, large-scale bulk API production for ampicillin and sulbactam is limited. Focus is often on R&D, specialty chemicals, or contract manufacturing for specific client needs rather than broad market supply.

What Regulatory Aspects Govern UNASYN API Production?

The manufacturing of APIs for UNASYN is subject to rigorous international regulatory oversight to ensure product safety, efficacy, and quality.

• Good Manufacturing Practices (GMP): Manufacturers must adhere to GMP guidelines set forth by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). These standards cover all aspects of production, including personnel, premises, equipment, raw materials, production processes, quality control, and documentation.

  • FDA's current GMP regulations are outlined in 21 CFR Part 210 and 211.
  • EMA's EudraLex Volume 4 provides EU GMP guidelines.

• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and quality control of the API. Pharmaceutical companies seeking to use an API in their finished drug product can reference the DMF in their marketing authorization applications.

  • U.S. DMFs are submitted to the FDA.
  • European Drug Master Files (EDMFs) are submitted to national competent authorities or via the centralized procedure.

• Inspections and Audits: Regulatory agencies conduct periodic inspections of manufacturing facilities to ensure ongoing compliance with GMP. Pharmaceutical companies also conduct their own audits of API suppliers as part of their supplier qualification process.

  • FDA inspections follow the Site Inspection Program.
  • EMA relies on inspections conducted by national competent authorities of EU member states.

• Impurity Profiling and Control: Strict limits are placed on impurities in APIs. Manufacturers must identify, quantify, and control potential impurities, including residual solvents, heavy metals, and process-related byproducts, as per ICH guidelines (e.g., ICH Q3A(R2) for impurities in new drug substances).

• Stability Testing: APIs must undergo stability testing to determine their shelf-life and appropriate storage conditions, in accordance with ICH Q1A(R2) guidelines.

What are the Supply Chain Risks for UNASYN APIs?

The global nature of pharmaceutical supply chains introduces several risks that can impact the availability and cost of UNASYN APIs.

• Geopolitical Instability: Concentration of manufacturing in certain countries (e.g., China, India) makes the supply chain vulnerable to trade disputes, tariffs, export restrictions, or local political unrest.

  • Example: Trade tensions between major economies can lead to increased costs or limited access to raw materials.

• Regulatory Changes: Evolving regulatory requirements or unexpected enforcement actions in manufacturing countries can disrupt production or necessitate costly facility upgrades.

  • Example: Stricter environmental regulations in China have, at times, led to temporary shutdowns of chemical plants.

• Natural Disasters and Pandemics: Events such as earthquakes, floods, or widespread health crises can halt manufacturing operations, disrupt logistics, and impact the availability of skilled labor.

  • Example: The COVID-19 pandemic significantly affected global pharmaceutical supply chains, causing shortages of raw materials and finished products.

• Quality Control Failures: Contamination, manufacturing errors, or substandard quality control at any stage of the API production can lead to product recalls or regulatory sanctions, affecting the reliability of a supplier.

  • Example: A batch rejection due to unexpected impurities can lead to significant delays and financial losses.

• Intellectual Property and Patent Expiries: While ampicillin and sulbactam are well-established generics, patents on specific manufacturing processes or novel formulations can influence market dynamics and supplier selection. Patent expirations can increase competition but also lead to a rush of new suppliers, potentially impacting quality consistency if not managed carefully.

• Raw Material Sourcing: Reliance on specific raw material suppliers, particularly for precursors like 6-APA, creates dependencies. Any disruption in the supply of these key intermediates can cascade through the entire UNASYN production chain.

How is the Market for Ampicillin and Sulbactam APIs Structured?

The market for ampicillin and sulbactam APIs is largely characterized by the production of generic drugs. The structure reflects the established nature of these antibiotics.

• Generic Dominated: UNASYN is a widely available generic antibiotic. This means the market for its APIs is driven by volume and cost efficiency.
• Key Players: Dominated by large-scale API manufacturers in China and India that can produce at competitive prices and meet global quality standards.
• Contract Manufacturing: Some finished drug product manufacturers may not produce their own APIs and rely on contract manufacturing organizations (CMOs) or directly source from API producers.
• Pricing Pressures: Intense competition among generic drug manufacturers and API suppliers leads to significant pricing pressures. Manufacturers focus on process optimization and economies of scale to remain competitive.
• Quality and Regulatory Compliance as Differentiators: While cost is a primary driver, consistent quality and robust regulatory compliance are essential for suppliers to gain and retain market share, especially in highly regulated markets like the US and EU.
• Limited New Entrants: Due to the maturity of the market and the significant investment required for GMP-compliant facilities and regulatory approvals, new large-scale entrants are uncommon. The barriers to entry are substantial.

Key Takeaways

• UNASYN API manufacturing is concentrated among a few key global suppliers, primarily in China and India.
• Sichuan Kelun Pharmaceutical Co., Ltd. and Astron Pharma are identified as significant direct suppliers of ampicillin and sulbactam.
• The supply chain relies on critical raw materials like 6-Aminopenicillanic Acid (6-APA), with China and India as dominant sources.
• Regulatory compliance, particularly adherence to GMP and successful DMF filings, is a critical determinant for API manufacturers.
• Supply chain risks include geopolitical instability, regulatory shifts, quality control failures, and disruptions in raw material sourcing.
• The API market is largely generic, characterized by high volume, cost competition, and a focus on economies of scale.

Frequently Asked Questions

1. What are the primary regulatory bodies that oversee UNASYN API production?

The primary regulatory bodies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national competent authorities within other major markets. The World Health Organization (WHO) also sets GMP standards influential globally.

2. How long does it typically take to qualify a new UNASYN API supplier?

Qualifying a new API supplier typically involves a rigorous process including site audits, review of Drug Master Files (DMFs), quality agreements, and potentially bioequivalence studies for the finished product. This process can range from six months to over a year, depending on the depth of the review and the supplier's existing compliance record.

3. Are there any patented manufacturing processes for ampicillin or sulbactam that impact generic supply?

While ampicillin and sulbactam are old, well-established generics, patents may exist for specific, more efficient synthetic routes, improved purification methods, or crystalline forms. However, the broad patent expiries for the core molecules mean that most generic API production occurs without direct patent infringement.

4. What is the typical capacity for ampicillin and sulbactam API production in China and India?

Exact figures vary by manufacturer, but China and India collectively account for the vast majority of global penicillin-derived antibiotic API production. Capacities are measured in hundreds to thousands of metric tons annually for individual APIs like ampicillin. Specific capacity for sulbactam is lower but still significant.

5. How are price fluctuations in key raw materials like 6-APA managed by UNASYN API suppliers?

API suppliers manage price fluctuations through long-term supply contracts with raw material providers, hedging strategies, building buffer stock, and continuously optimizing their own manufacturing processes for efficiency. However, significant raw material price spikes can still impact API pricing, especially for contract-based sales.

Cited Sources

[1] U.S. Food and Drug Administration. (2023). Guidance for Industry: ANDAs — Amendments to Approved Applications. U.S. Department of Health and Human Services. [2] European Medicines Agency. (2010). EudraLex - The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. European Commission. [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2015). ICH Harmonised Tripartite Guideline Impurities in New Drug Substances Q3A(R2). [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2003). ICH Harmonised Tripartite Guideline Impurities in New Drug Substances Q1A(R2). [5] Sichuan Kelun Pharmaceutical Co., Ltd. Company Website. (Accessed 2023). Information on API manufacturing capabilities and product portfolio. (Note: Specific URLs for investor relations or product pages are not directly citeable for this analysis without direct access to proprietary databases or specific corporate reports.) [6] Astron Pharma. Company Website. (Accessed 2023). Information on API manufacturing and regulatory approvals. (Note: Specific URLs for investor relations or product pages are not directly citeable for this analysis without direct access to proprietary databases or specific corporate reports.) [7] Divi's Laboratories Limited. Company Website. (Accessed 2023). Information on API manufacturing and regulatory compliance. (Note: Specific URLs for investor relations or product pages are not directly citeable for this analysis without direct access to proprietary databases or specific corporate reports.) [8] Biocon Ltd. Company Website. (Accessed 2023). Information on fermentation-derived APIs. (Note: Specific URLs for investor relations or product pages are not directly citeable for this analysis without direct access to proprietary databases or specific corporate reports.) [9] Fermenta Biotech Ltd. Company Website. (Accessed 2023). Information on penicillin derivatives. (Note: Specific URLs for investor relations or product pages are not directly citeable for this analysis without direct access to proprietary databases or specific corporate reports.)