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Last Updated: April 8, 2025

Steri Pharma Company Profile


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What is the competitive landscape for STERI PHARMA

STERI PHARMA has two approved drugs.



Summary for Steri Pharma
US Patents:0
Tradenames:1
Ingredients:1
NDAs:2

Drugs and US Patents for Steri Pharma

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Steri Pharma CEFAZOLIN SODIUM cefazolin sodium INJECTABLE;INJECTION 063208-001 Dec 27, 1991 DISCN No No ⤷  Try for Free ⤷  Try for Free
Steri Pharma CEFAZOLIN SODIUM cefazolin sodium INJECTABLE;INJECTION 063216-001 Dec 27, 1991 DISCN No No ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
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Steri Pharma: A Leading Force in Pharmaceutical Manufacturing

Steri Pharma has established itself as a prominent player in the pharmaceutical industry, specializing in the production of high-quality human antibiotics. With a global presence and a commitment to excellence, the company has positioned itself as a trusted partner for pharmaceutical professionals, distributors, and regulatory agencies worldwide.

Global Reach and Market Presence

Steri Pharma's influence extends far beyond its home base, with approvals in 40 countries across North America, Europe, Latin America, and Asia[1]. This extensive global footprint underscores the company's ability to meet diverse regulatory requirements and cater to a wide range of markets.

Quality-Driven Approach

At the core of Steri Pharma's success is its unwavering commitment to quality. The company's operations are driven by cutting-edge technology and processes, adhering to all regulatory approvals[8]. This dedication to quality extends beyond mere compliance, forming an integral part of the company's identity and culture.

"Quality is considered paramount at Steri-Pharma where we conduct regulated research, manufacturing, testing and distribution of pharmaceutical products."[8]

Product Portfolio and Specialization

Steri Pharma's primary focus is on human antibiotics, a critical segment of the pharmaceutical market. The company has gained recognition for producing both sterile and non-sterile antibiotics, with a particular emphasis on cephalosporins[6].

Manufacturing Capabilities

The company's manufacturing facility, spanning 75,000 square feet, is a testament to its production capacity and technological prowess. With 30,000 square feet dedicated to manufacturing, 30,000 square feet for office space and mechanical areas, and 15,000 square feet of warehouse space, Steri Pharma is well-equipped to meet the demands of its global clientele[6].

Competitive Advantages

Several factors contribute to Steri Pharma's strong market position:

1. Quality Management System

Steri Pharma's robust global quality management system is designed to sustain a culture of operational excellence. This system not only meets but often exceeds the expectations of stakeholders, including customers and regulators[8].

2. Regulatory Compliance

The company's insistence on compliance with national and international regulatory and business standards is ingrained in its corporate DNA. This commitment ensures that every product manufactured and distributed by Steri Pharma complies with internationally accepted good practices and standards of quality, purity, efficacy, and safety[8].

3. Continuous Improvement

Steri Pharma consistently benchmarks its quality standards against global best practices, ensuring that they are regularly upgraded to keep pace with the evolving dynamics of the global environment[8].

Market Trends and Opportunities

The pharmaceutical sterility testing market, in which Steri Pharma operates, is experiencing significant growth. The global market size was estimated at USD 1.59 billion in 2023 and is projected to grow at a CAGR of 11.02% from 2024 to 2030[7].

Key Growth Drivers

Several factors are contributing to the expansion of the pharmaceutical sterility testing market:

  1. Rising prevalence of chronic diseases
  2. Increased adoption of injectable biologics
  3. Growing number of hospitalizations
  4. Rising utilization of injectable drugs in oncology
  5. Expansion of vaccine manufacturing
  6. Growing adoption of injectable drugs in the geriatric population
  7. Increased use of injectable antibiotics in critical care
  8. Growing trend of home healthcare and self-administration[5]

These trends present significant opportunities for companies like Steri Pharma to expand their market share and develop innovative products to meet evolving healthcare needs.

Strategic Initiatives and Future Outlook

While specific information about Steri Pharma's recent strategic initiatives is limited in the provided search results, the company's focus on quality, global expansion, and technological advancement positions it well for future growth.

Industry Partnerships

The pharmaceutical industry is seeing a trend towards strategic partnerships to enhance capabilities and streamline operations. For example, SHL Medical's recent partnership with SteriPack Group to establish a pre-validated final assembly service demonstrates the industry's move towards more flexible and personalized solutions[9]. While not directly related to Steri Pharma, this trend suggests potential opportunities for similar collaborations in the future.

Market Expansion

Given Steri Pharma's current approval in 40 countries, there may be room for further geographic expansion. The company could potentially target emerging markets or strengthen its presence in existing regions.

Product Development

With the growing demand for injectable drugs and antibiotics, Steri Pharma may consider expanding its product portfolio or investing in research and development to create new, innovative antibiotic formulations.

Challenges and Competition

While Steri Pharma has established a strong market position, it operates in a highly competitive industry. The pharmaceutical sterility testing market includes several key players such as Pacific Biolabs, Steris Plc, Boston Analytical, Nelson Laboratories, LLC, Sartorius AG, SOLVIAS AG, SGS SA, Labcorp, and Pace Analytical[7].

To maintain its competitive edge, Steri Pharma will need to continue investing in quality assurance, regulatory compliance, and technological innovation. The company will also need to navigate challenges such as increasing regulatory scrutiny, pricing pressures, and the need for continuous innovation in antibiotic development.

Key Takeaways

  1. Steri Pharma is a global leader in human antibiotic manufacturing, with approvals in 40 countries across multiple continents.
  2. The company's unwavering commitment to quality and regulatory compliance sets it apart in the pharmaceutical industry.
  3. Steri Pharma's state-of-the-art manufacturing facilities and focus on both sterile and non-sterile antibiotics position it well in the market.
  4. The growing pharmaceutical sterility testing market presents significant opportunities for expansion and innovation.
  5. Strategic partnerships, market expansion, and continued product development will be crucial for Steri Pharma's future growth and competitiveness.

FAQs

  1. What is Steri Pharma's primary focus in pharmaceutical manufacturing? Steri Pharma specializes in the production of high-quality human antibiotics, including both sterile and non-sterile formulations.

  2. How extensive is Steri Pharma's global presence? Steri Pharma is currently approved for operations in 40 countries across North America, Europe, Latin America, and Asia.

  3. What sets Steri Pharma apart from its competitors? Steri Pharma's commitment to quality, regulatory compliance, and continuous improvement in its manufacturing processes distinguishes it in the pharmaceutical industry.

  4. What are the key growth drivers in the pharmaceutical sterility testing market? Key drivers include the rising prevalence of chronic diseases, increased adoption of injectable biologics, growing number of hospitalizations, and expansion of vaccine manufacturing.

  5. How is Steri Pharma positioned to take advantage of future market opportunities? With its strong focus on quality, global presence, and specialized manufacturing capabilities, Steri Pharma is well-positioned to capitalize on the growing demand for antibiotics and sterile pharmaceutical products.

Sources cited:

  1. https://www.steri-pharma.com/about-us/global-presence/
  2. https://www.globenewswire.com/news-release/2024/11/06/2975894/28124/en/Sterile-Injectable-Drugs-Strategic-Market-Research-Report-2024-Global-Market-to-Reach-1-4-Trillion-by-2030-Biosimilars-Gain-Traction-Opening-New-Opportunities.html
  3. https://www1.nationalgridus.com/%5Cfiles%5CAddedPDF%5CPOA%5CEE5296_SteriPharmaNew.pdf
  4. https://www.grandviewresearch.com/industry-analysis/pharmaceutical-sterility-testing-market
  5. https://www.steri-pharma.com/infrastructure/quality/
  6. https://www.shl-medical.com/news-insights/news/shl-medical-partners-with-steripack-group-to-set-up-final-assembly-service

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