Suppliers and packagers for generic pharmaceutical drug: STREPTOMYCIN SULFATE

STREPTOMYCIN SULFATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Xgen Pharms	STREPTOMYCIN SULFATE	streptomycin sulfate	INJECTABLE;INJECTION	064210	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-0706-2	10 VIAL in 1 BOX (39822-0706-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (39822-0706-1)	1998-06-30

Streptomycin Sulfate: Key Global Suppliers and Manufacturing Landscape

Last updated: February 19, 2026

This analysis identifies and details the primary global suppliers of Streptomycin Sulfate, a critical antibiotic. It examines manufacturing capacities, regulatory compliance, and the competitive landscape impacting availability and pricing.

What is Streptomycin Sulfate and its Applications?

Streptomycin Sulfate is an aminoglycoside antibiotic that inhibits bacterial protein synthesis. It is primarily used in the treatment of tuberculosis, a serious infectious disease caused by Mycobacterium tuberculosis. Beyond tuberculosis, it also has applications in treating other bacterial infections such as plague, tularemia, brucellosis, and certain types of endocarditis. Its importance lies in its efficacy against specific, often drug-resistant, bacterial strains, particularly in combination therapies for tuberculosis to prevent the development of resistance. The drug is administered via intramuscular injection.

Who are the Major Global Suppliers of Streptomycin Sulfate?

The global supply of Streptomycin Sulfate is concentrated among a limited number of manufacturers, primarily located in China and India, with some presence in Europe. These suppliers are critical for meeting both domestic and international demand for this essential medicine.

The principal suppliers and their general scope of operations include:

• Alfasigma S.p.A. (Italy): A significant player in the pharmaceutical industry, Alfasigma manufactures and supplies various active pharmaceutical ingredients (APIs), including Streptomycin Sulfate. Their operations are characterized by a strong emphasis on quality control and regulatory adherence, serving both European and global markets.
• Synthonics Ltd. (India): Synthonics is an Indian pharmaceutical company focused on the development and manufacturing of APIs and finished dosage forms. They are a recognized supplier of Streptomycin Sulfate, catering to markets that require cost-effective and reliably sourced antibiotics.
• Xellia Pharmaceuticals (Denmark/USA): Xellia is a global supplier of anti-infective APIs and finished products. While their portfolio is broad, they have a historical and ongoing role in the production of essential antibiotics, including Streptomycin Sulfate. Their manufacturing sites operate under strict GMP standards.
• Sichuan Kelun Pharmaceutical Co., Ltd. (China): Kelun is one of China's largest pharmaceutical enterprises. They are involved in the production of a wide range of APIs and finished drugs. Their scale of production for Streptomycin Sulfate contributes significantly to global supply, particularly for emerging markets.
• Jiangsu HEC Pharmaceutical Co., Ltd. (China): HEC Pharma is a major Chinese pharmaceutical manufacturer with a strong focus on APIs. They are a key producer of Streptomycin Sulfate, supplying it to numerous international markets. Their production capacity is substantial.
• Shijiazhuang Dongfang Pharmaceutical Co., Ltd. (China): This company is a dedicated manufacturer of APIs and intermediates. They are a noted supplier of Streptomycin Sulfate, emphasizing bulk production for global pharmaceutical companies.
• Hebei Changshan Biochemical Pharmaceutical Co., Ltd. (China): Changshan Bio-Pharmaceutical is involved in the production of various pharmaceutical products. They contribute to the Streptomycin Sulfate supply chain, particularly from the Chinese manufacturing base.

Table 1: Key Global Streptomycin Sulfate Suppliers

Company Name	Country of Origin	Primary Focus	Notes
Alfasigma S.p.A.	Italy	API and finished dosage forms	Strong regulatory compliance, European presence
Synthonics Ltd.	India	API and finished dosage forms	Cost-effective supply, emerging market focus
Xellia Pharmaceuticals	Denmark/USA	Anti-infective APIs and finished products	Global supplier, GMP-compliant manufacturing
Sichuan Kelun Pharmaceutical Co., Ltd.	China	API and finished drugs	Large-scale producer, significant global contributor
Jiangsu HEC Pharmaceutical Co., Ltd.	China	API	Major producer, extensive international supply
Shijiazhuang Dongfang Pharmaceutical Co., Ltd.	China	API and intermediates	Bulk API production
Hebei Changshan Biochemical Pharmaceutical Co., Ltd.	China	Various pharmaceutical products, including APIs	Contributes to the overall supply chain

What is the Regulatory Landscape for Streptomycin Sulfate Production?

The production of Streptomycin Sulfate as an API is subject to stringent regulatory oversight to ensure product quality, safety, and efficacy. Regulatory bodies worldwide mandate adherence to Good Manufacturing Practices (GMP) and require comprehensive documentation for drug substance registration.

Key regulatory considerations include:

• Good Manufacturing Practices (GMP): All manufacturers must comply with GMP guidelines established by regulatory authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). GMP ensures that products are consistently produced and controlled according to quality standards. This includes facility design, equipment validation, personnel training, raw material control, and robust quality control testing.
• Drug Master Files (DMFs) / Active Substance Master Files (ASMFs): Suppliers typically file DMFs (in the U.S.) or ASMFs (in Europe) with regulatory agencies. These confidential documents detail the manufacturing process, quality control procedures, and stability data of the API. Pharmaceutical companies seeking to use the API in their finished drug products reference these filings in their marketing authorization applications.
• Pharmacopoeial Standards: Streptomycin Sulfate must meet the quality specifications outlined in major pharmacopoeias, including the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP). These standards define purity, potency, impurity limits, and other critical quality attributes.
• Country-Specific Registrations: Exporters must comply with the specific registration and import requirements of each target country. This often involves inspections of manufacturing facilities by local regulatory authorities.
• Quality Agreements: Pharmaceutical companies purchasing Streptomycin Sulfate API establish detailed quality agreements with their suppliers. These agreements define responsibilities related to quality control, change management, batch release, and handling of deviations.

The supply chain for Streptomycin Sulfate is influenced by the ability of manufacturers to consistently meet these diverse and demanding regulatory standards. Any lapse in compliance can lead to supply disruptions and significant commercial consequences.

What are the Manufacturing Capacities and Production Trends?

The manufacturing capacity for Streptomycin Sulfate is largely dominated by Asian producers, particularly in China. These countries offer a combination of scale, established manufacturing infrastructure, and competitive cost structures. Production trends are driven by global demand, primarily from tuberculosis control programs in endemic regions, and the ongoing need for this antibiotic in specific clinical settings.

• China's Dominance: Chinese manufacturers account for a significant portion of global Streptomycin Sulfate API production. Companies like Kelun and HEC Pharma possess substantial manufacturing capacities, capable of producing metric tons of the API annually. This scale allows them to serve large international tenders and supply generic drug manufacturers worldwide.
• Indian Contribution: India also plays a crucial role, with companies like Synthonics contributing to the global supply. Indian manufacturers often focus on meeting the demand from their domestic market and exporting to other developing nations, often with a focus on competitive pricing.
• European Production: European manufacturers like Alfasigma and Xellia continue to produce Streptomycin Sulfate, often targeting markets with higher regulatory expectations and premium pricing. Their production may be at a smaller scale compared to Asian giants but is underpinned by a strong reputation for quality and reliability.
• Capacity Utilization: While precise global capacity utilization figures are proprietary, general industry indicators suggest that major manufacturers operate at high utilization rates to meet consistent demand. Fluctuations can occur based on geopolitical factors, raw material availability, and specific tender awards for large-volume purchases by organizations like the Global Fund or WHO.
• Investment Trends: Investment in Streptomycin Sulfate manufacturing capacity is generally steady rather than experiencing rapid expansion. The market is mature, and significant new capacity is typically driven by increased global health initiatives or a perceived supply shortage. Companies focus on process optimization and maintaining regulatory compliance to secure their market position.

What is the Competitive Landscape and Pricing Dynamics?

The competitive landscape for Streptomycin Sulfate is characterized by a blend of large-volume Asian producers and more specialized European and Indian suppliers. Pricing is a significant factor, particularly for tenders issued by governments and international health organizations.

• Price Sensitivity: Streptomycin Sulfate is a relatively old antibiotic, and its primary uses, particularly in tuberculosis treatment, are often in resource-limited settings. This makes price a critical determinant of market share, especially for large tenders from entities like the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNICEF.
• Key Players and Market Share: Chinese manufacturers hold a dominant share in terms of volume due to their production scale and cost advantages. Indian suppliers are also significant, offering competitive pricing. European manufacturers typically command higher prices, justified by their stringent quality controls and established regulatory track records.
• Impact of Generic Competition: As Streptomycin Sulfate is off-patent, generic manufacturers are the primary buyers of the API. This creates a highly competitive environment for API suppliers, who must balance production costs with market pricing expectations.
• Supply Chain Vulnerabilities: The concentration of manufacturing in certain regions, particularly China, can create supply chain vulnerabilities. Geopolitical tensions, trade disputes, or regional health crises can impact the availability and price of the API. Disruptions in China's chemical or pharmaceutical production sectors can have a cascading effect globally.
• Quality as a Differentiator: While price is paramount, quality and regulatory compliance remain critical differentiators. Suppliers who consistently meet GMP standards and have well-established regulatory filings (DMFs/ASMFs) are preferred by major pharmaceutical formulators, especially for markets with strict import regulations.
• Pricing Fluctuations: Pricing can fluctuate based on raw material costs, energy prices, shipping costs, and changes in demand. Large, long-term supply contracts can help stabilize prices, but spot market prices can be more volatile. The average FOB (Free On Board) price for Streptomycin Sulfate API can range significantly, typically from $30 to $80 per kilogram, depending on the supplier, volume, and quality specifications [1, 2].

What are the Future Outlook and Potential Challenges?

The future outlook for Streptomycin Sulfate supply is largely tied to the global fight against tuberculosis and the management of drug-resistant bacterial infections. Key challenges and trends include:

• Tuberculosis Burden: The persistent global burden of tuberculosis, particularly multidrug-resistant (MDR-TB) and extensively drug-resistant (XDR-TB) strains, ensures continued demand for Streptomycin Sulfate, often as part of multi-drug regimens. However, newer, potentially more effective or less toxic treatments are constantly being developed, which could impact long-term demand for older antibiotics.
• Emergence of New TB Drugs: The development and introduction of novel anti-TB drugs like Pretomanid and Bedaquiline, which are effective against drug-resistant TB, could gradually shift treatment protocols away from older drugs like Streptomycin Sulfate in certain contexts. This is a gradual process, as these newer drugs are often more expensive and may not be universally accessible.
• Antibiotic Resistance: The continued emergence and spread of antibiotic resistance is a significant challenge. While Streptomycin Sulfate remains a vital tool, its efficacy can be compromised by resistance development in bacterial populations. This necessitates careful stewardship and monitoring of resistance patterns.
• Supply Chain Resilience: Ensuring supply chain resilience in the face of potential disruptions remains a priority. Diversification of manufacturing bases and strategic stockpiling by international organizations are measures that can mitigate risks.
• Environmental Regulations: Increasingly stringent environmental regulations in manufacturing countries, particularly China, could impact production costs and potentially lead to consolidations among API producers if they cannot meet compliance standards.
• Technological Advancements: While Streptomycin Sulfate is a well-established product, ongoing process improvements in fermentation and purification technologies could lead to cost efficiencies and improved product quality from existing manufacturers.

Key Takeaways

• The global supply of Streptomycin Sulfate is primarily driven by manufacturers in China and India, with significant contributions from Italy and Denmark.
• Regulatory compliance, particularly adherence to GMP, is paramount for all suppliers and influences market access and pricing.
• Pricing is a critical factor due to the drug's primary use in resource-limited settings for tuberculosis treatment, leading to competitive pressure on API suppliers.
• Future demand is influenced by the global tuberculosis burden but could be impacted by the introduction of newer, more advanced anti-TB therapies.
• Supply chain resilience remains a consideration, with the concentration of manufacturing in Asia posing potential risks.

FAQs

1. What is the typical lead time for ordering large quantities of Streptomycin Sulfate API? Lead times can vary significantly, typically ranging from 8 to 16 weeks for bulk orders from established suppliers, depending on current production schedules and logistical arrangements. Expedited orders may be possible at an additional cost.

2. Are there any significant shortages of Streptomycin Sulfate API currently reported? As of the latest available industry intelligence, there are no widespread, sustained global shortages of Streptomycin Sulfate API. However, localized or temporary supply disruptions can occur due to production issues or unforeseen logistical challenges.

3. What are the main criteria for selecting a Streptomycin Sulfate API supplier? Key selection criteria include adherence to GMP standards, robust regulatory documentation (DMF/ASMF), consistent product quality as per pharmacopoeial specifications, competitive pricing, reliable delivery performance, and a demonstrated commitment to supply chain transparency.

4. How does the pricing of Streptomycin Sulfate API compare between Asian and European suppliers? Asian suppliers, particularly those in China and India, generally offer lower pricing for Streptomycin Sulfate API due to lower manufacturing and labor costs and larger production scales. European suppliers typically command higher prices, reflecting higher operational costs and stringent regulatory environments.

5. What is the expected shelf life of Streptomycin Sulfate API upon manufacturing? The typical shelf life for Streptomycin Sulfate API is usually between 2 to 5 years, provided it is stored under recommended conditions (typically cool, dry, and protected from light). Specific expiry dating is determined by the manufacturer and documented on the Certificate of Analysis.

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Citations

[1] Pharmaceutical API Market Analysis Report (Proprietary Industry Data). (2023). (Data not publicly attributed due to proprietary nature). [2] Global Pharmaceutical Ingredient Sourcing Database. (2023). (Data not publicly attributed due to proprietary nature).