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Last Updated: April 14, 2025

Chartwell Rx Company Profile


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What is the competitive landscape for CHARTWELL RX

CHARTWELL RX has four hundred and forty-one approved drugs.

There are two tentative approvals on CHARTWELL RX drugs.

Summary for Chartwell Rx
US Patents:0
Tradenames:314
Ingredients:298
NDAs:441

Drugs and US Patents for Chartwell Rx

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Chartwell Rx DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 078388-002 Nov 26, 2010 DISCN No No ⤷  Try for Free ⤷  Try for Free
Chartwell Rx MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 091424-004 Nov 30, 2011 AB RX No No ⤷  Try for Free ⤷  Try for Free
Chartwell Rx THIORIDAZINE HYDROCHLORIDE thioridazine hydrochloride TABLET;ORAL 088134-001 Aug 30, 1983 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
Showing 1 to 3 of 3 entries

Expired US Patents for Chartwell Rx

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Chartwell Rx MOBAN molindone hydrochloride TABLET;ORAL 017111-004 Approved Prior to Jan 1, 1982 3,491,093 ⤷  Try for Free
Chartwell Rx MOBAN molindone hydrochloride TABLET;ORAL 017111-005 Approved Prior to Jan 1, 1982 3,491,093 ⤷  Try for Free
Chartwell Rx MOBAN molindone hydrochloride TABLET;ORAL 017111-006 Approved Prior to Jan 1, 1982 3,491,093 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Chartwell Rx – Market Position, Strengths & Strategic Insights

In the dynamic world of pharmaceuticals, understanding the competitive landscape is crucial for success. Chartwell Pharmaceuticals, operating under the Chartwell Rx label, has emerged as a significant player in the US pharmaceutical market. This analysis delves into Chartwell Rx's market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Company Overview

Chartwell Pharmaceuticals is a US-based, full-service pharmaceutical organization specializing in manufacturing, packaging, laboratory services, and supply chain management[1]. Founded in 2010, the company has established itself as a reliable producer of high-quality prescription pharmaceutical products over the past two decades[1][2].

Key Facts:

  • Annual Revenue: $28.8 million (2025)[1]
  • Employees: 118 (91 on RocketReach)[1]
  • Headquarters: Congers, New York[1]
  • Founded: 2010[1]

Market Position

Chartwell Pharmaceuticals has carved out a strong position in the US pharmaceutical market, particularly in the generic prescription drug sector. The company's focus on manufacturing "Made in the USA" products has allowed it to meet the growing demand for Trade Act Agreement (TAA) and Buy American Act (BAA) compliant products[1][2].

Product Portfolio

With over 900 FDA-Approved Rx listings in the Orange Book, Chartwell Rx offers a diverse range of pharmaceutical products[2]. Their portfolio includes:

  • Tablets
  • Capsules
  • Powders
  • Solutions and suspensions
  • Semi-solids
  • Ophthalmics
  • Otics
  • Injectable forms (upcoming)[2]

This extensive product range demonstrates Chartwell's ability to cater to various medical needs and market segments.

Manufacturing Capabilities

Chartwell Pharmaceuticals operates four main manufacturing and analytical campuses in the New York metropolitan area[2]. These state-of-the-art facilities are fully cGMP compliant and utilize sophisticated technologies to ensure the production of high-quality pharmaceuticals[2].

Production Flexibility

One of Chartwell's key strengths is its ability to handle various production scales, from formulation trials to clinical supplies and full-scale commercial batches[2]. This flexibility allows the company to meet diverse client needs and adapt to changing market demands.

Competitive Advantages

Chartwell Pharmaceuticals has several competitive advantages that set it apart in the pharmaceutical landscape:

1. US-Based Manufacturing

As a US-based manufacturer, Chartwell benefits from the growing preference for domestically produced pharmaceuticals. This positioning aligns with government initiatives promoting American-made products[1][2].

2. Extensive Industry Experience

The company's leadership team and technical staff bring decades of pharmaceutical industry experience, providing a strong foundation for innovation and reliability[1].

3. Diverse Product Portfolio

With a wide range of dosage forms and over 900 FDA-approved listings, Chartwell can cater to various market segments and customer needs[2].

4. Compliance and Quality

Chartwell's commitment to cGMP compliance and use of sophisticated technologies ensures consistent product quality, a critical factor in the pharmaceutical industry[2].

5. Flexibility and Customization

The company's ability to provide customized pharmaceutical support services allows it to meet the unique needs of diverse clients, from major pharmaceutical manufacturers to government entities and pharmacy retailers[5].

Strategic Insights

Chartwell Pharmaceuticals' strategic approach focuses on several key areas:

Expansion and Upgrades

The company is continuously expanding and upgrading its capabilities to address the growing need for reliable, US-made pharmaceutical products[2]. This strategy positions Chartwell to capitalize on market trends favoring domestic production.

Government and Specialty Focus

Chartwell has created a dedicated Government and Specialty division to meet the unique needs of government entities and other institutions[5]. This strategic move allows the company to tap into lucrative government contracts and specialized markets.

"As a qualified small business manufacturing in the USA, we provide our government and speciality clients with deep industry expertise and flexible, robust production capabilities."[5]

Research and Development

Under the leadership of Kiran, who heads R&D and Technical Services, Chartwell is focusing on implementing new developmental strategies to simplify processes and bring cost-effective medications to the market[6]. This emphasis on innovation and efficiency is crucial for maintaining competitiveness in the generic drug market.

Market Opportunities

The pharmaceutical landscape presents several opportunities for Chartwell Rx to leverage its strengths and expand its market presence:

1. Growing Demand for US-Made Pharmaceuticals

With increasing concerns about supply chain security and government initiatives promoting domestic production, Chartwell's US-based manufacturing capabilities position it well to capture market share[1][2].

2. Expansion into New Dosage Forms

Chartwell's planned entry into injectable forms represents an opportunity to tap into new market segments and diversify its product portfolio further[2].

3. Government Contracts

The company's experience in supplying the Federal Emergency Stockpile and supporting Defense Logistics Agency Corporate Exigency Contracts provides a strong foundation for securing additional government contracts[5].

4. Customized Solutions

Chartwell's ability to provide tailored pharmaceutical support services opens up opportunities to partner with a wide range of clients, from major pharmaceutical companies to specialized institutions[5].

Challenges and Competitive Landscape

While Chartwell Pharmaceuticals has established a strong position in the market, it faces several challenges and competitive pressures:

1. Intense Competition

The generic pharmaceutical market is highly competitive, with established players like Pfizer, Amgen, Bristol Myers Squibb, and Teva Pharmaceuticals dominating the landscape[1].

2. Regulatory Pressures

As with all pharmaceutical companies, Chartwell must navigate complex regulatory environments and maintain compliance with evolving standards.

3. Pricing Pressures

The generic drug market often faces pricing pressures, requiring companies to continuously optimize their operations to maintain profitability.

4. Technological Advancements

Keeping pace with technological advancements in pharmaceutical manufacturing and research is crucial for maintaining competitiveness.

Future Outlook

Chartwell Pharmaceuticals is well-positioned to capitalize on market trends favoring US-based pharmaceutical production and the growing demand for reliable, high-quality generic drugs. The company's focus on innovation, quality, and customization provides a solid foundation for future growth.

Key areas for potential expansion include:

  1. Strengthening government partnerships
  2. Expanding into new dosage forms, particularly injectables
  3. Leveraging R&D capabilities to bring more cost-effective medications to market
  4. Exploring opportunities in specialized pharmaceutical niches

Key Takeaways

  • Chartwell Pharmaceuticals, operating as Chartwell Rx, is a significant player in the US generic pharmaceutical market with annual revenue of $28.8 million.
  • The company's US-based manufacturing capabilities and compliance with TAA and BAA requirements give it a competitive edge in the current market environment.
  • Chartwell's diverse product portfolio, including over 900 FDA-approved listings, allows it to cater to various market segments.
  • The company's focus on government contracts and specialized markets through its Government and Specialty division represents a strategic growth area.
  • Continuous expansion and upgrades of manufacturing capabilities position Chartwell to meet growing demand for US-made pharmaceuticals.
  • While facing intense competition and regulatory challenges, Chartwell's emphasis on innovation and customization provides a strong foundation for future growth.

FAQs

  1. What sets Chartwell Pharmaceuticals apart from other generic drug manufacturers? Chartwell's US-based manufacturing, diverse product portfolio, and focus on government and specialty markets give it a unique position in the pharmaceutical landscape.

  2. How does Chartwell ensure product quality? The company operates cGMP compliant facilities and utilizes sophisticated technologies to maintain consistent product quality across its manufacturing processes.

  3. What are Chartwell's main product categories? Chartwell produces a wide range of dosage forms, including tablets, capsules, powders, solutions, suspensions, semi-solids, ophthalmics, and otics, with plans to expand into injectables.

  4. How is Chartwell positioned to meet government pharmaceutical needs? Chartwell has a dedicated Government and Specialty division and experience supplying the Federal Emergency Stockpile, positioning it well for government contracts.

  5. What are the key growth areas for Chartwell Pharmaceuticals? Key growth areas include expanding government partnerships, entering new dosage forms like injectables, leveraging R&D for cost-effective medications, and exploring specialized pharmaceutical niches.

Sources cited: [1] https://rocketreach.co/chartwell-pharmaceuticals-profile_b5d78cfdf42e3d80 [2] https://chartwellpharma.com/about-chartwell/ [5] https://chartwellpharma.com/business-units/ [6] https://chartwellpharma.com/leadership/

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