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Last Updated: April 20, 2025

Sigmapharm Labs Llc Company Profile


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What is the competitive landscape for SIGMAPHARM LABS LLC

SIGMAPHARM LABS LLC has sixteen approved drugs.

There is one tentative approval on SIGMAPHARM LABS LLC drugs.

Summary for Sigmapharm Labs Llc
US Patents:0
Tradenames:16
Ingredients:16
NDAs:16

Drugs and US Patents for Sigmapharm Labs Llc

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Sigmapharm Labs Llc LIOTHYRONINE SODIUM liothyronine sodium TABLET;ORAL 200295-001 Nov 29, 2012 AB RX No No ⤷  Try for Free ⤷  Try for Free
Sigmapharm Labs Llc NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 207745-001 May 7, 2018 DISCN No No ⤷  Try for Free ⤷  Try for Free
Sigmapharm Labs Llc SODIUM PHENYLBUTYRATE sodium phenylbutyrate POWDER;ORAL 202819-001 Mar 22, 2013 AB RX 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
Showing 1 to 3 of 3 entries
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Pharmaceutical Competitive Landscape Analysis: Sigmapharm Labs LLC – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, understanding the competitive landscape is crucial for success. Today, we'll dive deep into Sigmapharm Laboratories LLC, a privately held specialty pharmaceutical company that has carved out a unique niche in the market. Let's explore their market position, strengths, and strategic insights that have contributed to their growth and success.

Company Overview

Sigmapharm Laboratories LLC, founded in 2005 by Dr. Spiro Spireas, has rapidly grown from a small specialty formulation house to a fully integrated pharmaceutical company. Based in Bensalem, PA, Sigmapharm focuses on developing, manufacturing, and marketing unique generic and branded drug products[2].

Market Position

Revenue and Growth

Sigmapharm Laboratories has shown impressive growth since its inception. As of the latest available data, the company boasts an estimated annual revenue of $20.9 million[1]. This places them in a competitive position within the specialty pharmaceutical market, particularly considering their relatively short history.

Employee Base and Productivity

With 104 employees, Sigmapharm maintains a lean and efficient operation[1]. Their estimated revenue per employee stands at an impressive $201,000, indicating high productivity levels within the organization.

"Sigmapharm Laboratories's estimated annual revenue is currently $20.9M per year. Sigmapharm Laboratories's estimated revenue per employee is $201,000" [1]

Competitive Landscape

In the highly competitive pharmaceutical industry, Sigmapharm faces competition from various players. Some of their top competitors include:

  1. Imaging Endpoints ($46.2M revenue, 230 employees)
  2. Southern Scripts ($43.8M revenue, 218 employees)
  3. Alfasigma USA ($57.1M revenue, 284 employees)[1]

While these competitors have higher revenues and larger employee bases, Sigmapharm's focus on unique, high barrier-to-entry products allows them to maintain a strong market position.

Strengths and Core Competencies

Innovative Product Development

Sigmapharm's strength lies in its ability to develop unique, cost-effective, high barrier-to-entry generic and branded drug products[2]. Their focus on difficult-to-formulate products has led to several of their marketed products facing minimal or no generic competition.

Proprietary Technology Platforms

The company's success is largely attributed to its proprietary technology platforms. These platforms enable Sigmapharm to innovate and develop products that often overcome complicated bioavailability and stability issues[2].

Quality Focus

Sigmapharm places a strong emphasis on quality, which has helped them earn trust from patients and customers. Their quality systems are known for their effectiveness and transparency[2].

Vertical Integration

As a fully integrated (or 'backward integrated') company, Sigmapharm has greater control over its supply chain and production processes. This integration allows for better quality control and potentially lower production costs[1].

Strategic Insights

Focus on High Barrier-to-Entry Products

Sigmapharm's strategy of focusing on high barrier-to-entry products has proven successful. This approach allows them to face less competition and potentially command higher profit margins.

Emphasis on Research and Development

The company's investment in R&D, particularly in developing proprietary technology platforms, has been a key driver of their success. This focus on innovation helps them stay ahead in a rapidly evolving industry.

Balanced Portfolio

Sigmapharm maintains a balanced portfolio of generic and branded products. This diversification helps mitigate risks associated with market fluctuations in either segment.

Product Portfolio

Sigmapharm's product portfolio includes both generic and branded pharmaceuticals. Some of their key products include:

  1. Adefovir Dipivoxil Tablets (generic equivalent to HEPSERA® Tablets)
  2. Amiloride Hydrochloride Tablets
  3. Liothyronine Sodium Tablets[2]

Regulatory Compliance and Approvals

Sigmapharm has a strong track record of regulatory compliance and approvals. Some key milestones include:

  • First ANDA Submission: June 2007
  • First GMP Inspection completed by the FDA: January 2008
  • First ANDA Approval: January 2009
  • First DMF Submission: June 2010[2]

Market Expansion and Future Outlook

Pipeline Development

Sigmapharm continues to focus on developing first-to-market, one-source products. Their current pipeline suggests this trend will continue, potentially leading to further market expansion and revenue growth[2].

Contract Development and Manufacturing

In addition to their own product development, Sigmapharm offers contract development and manufacturing services. This diversification of services provides an additional revenue stream and allows them to leverage their expertise and facilities[4].

Challenges and Opportunities

Challenges

  1. Rapid Industry Changes: The pharmaceutical industry is known for its rapid changes, which can pose challenges in keeping product pipelines relevant.

  2. Intense Competition: Despite their focus on high barrier-to-entry products, Sigmapharm still faces competition from larger pharmaceutical companies with more resources.

  3. Regulatory Hurdles: As with all pharmaceutical companies, navigating the complex regulatory landscape remains a constant challenge.

Opportunities

  1. Expansion of Contract Services: There's potential for Sigmapharm to expand its contract development and manufacturing services, leveraging its expertise and facilities.

  2. International Market Expansion: While currently focused on the U.S. market, there may be opportunities for international expansion.

  3. Emerging Therapeutic Areas: Exploring new therapeutic areas could open up new market opportunities for Sigmapharm.

Key Takeaways

  1. Sigmapharm Laboratories LLC has carved out a niche in the pharmaceutical industry by focusing on unique, high barrier-to-entry products.

  2. The company's estimated annual revenue of $20.9 million and high revenue per employee indicate efficient operations.

  3. Proprietary technology platforms and a strong focus on R&D are key drivers of Sigmapharm's success.

  4. The company's balanced portfolio of generic and branded products, along with contract services, provides diversification.

  5. While facing challenges such as rapid industry changes and intense competition, Sigmapharm has opportunities for growth through expansion of services and exploration of new markets.

FAQs

  1. Q: What sets Sigmapharm Laboratories apart from its competitors? A: Sigmapharm's focus on developing unique, high barrier-to-entry products using proprietary technology platforms sets them apart in the competitive pharmaceutical landscape.

  2. Q: How does Sigmapharm's revenue compare to its main competitors? A: While Sigmapharm's estimated annual revenue of $20.9 million is lower than some competitors like Imaging Endpoints ($46.2M) and Alfasigma USA ($57.1M), their revenue per employee is competitive, indicating efficient operations.

  3. Q: What are some of Sigmapharm's key product offerings? A: Some of Sigmapharm's key products include Adefovir Dipivoxil Tablets (generic equivalent to HEPSERA® Tablets), Amiloride Hydrochloride Tablets, and Liothyronine Sodium Tablets.

  4. Q: How does Sigmapharm approach quality control? A: Sigmapharm places a strong emphasis on quality, with effective and transparent quality systems that help them earn trust from patients and customers.

  5. Q: What future growth opportunities exist for Sigmapharm? A: Potential growth opportunities for Sigmapharm include expanding their contract development and manufacturing services, exploring international markets, and venturing into new therapeutic areas.

Sources cited: [1] https://growjo.com/company/Sigmapharm_Laboratories [2] https://www.sigmapharm.com/about-us [4] https://pharmasource.global/directory/sigmapharm-laboratories/

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