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Last Updated: April 14, 2025

Granules Company Profile


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What is the competitive landscape for GRANULES

GRANULES has sixty-eight approved drugs.

There is one tentative approval on GRANULES drugs.

Summary for Granules
US Patents:0
Tradenames:52
Ingredients:52
NDAs:68

Drugs and US Patents for Granules

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Granules BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 215568-002 Feb 2, 2022 AB3 RX No No ⤷  Try for Free ⤷  Try for Free
Granules BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 218385-003 Oct 17, 2024 AB1 RX No No ⤷  Try for Free ⤷  Try for Free
Granules LAMOTRIGINE lamotrigine TABLET;ORAL 078982-001 Jan 27, 2009 DISCN No No ⤷  Try for Free ⤷  Try for Free
Granules LEVETIRACETAM levetiracetam TABLET;ORAL 217878-003 Jun 13, 2023 DISCN No No ⤷  Try for Free ⤷  Try for Free
Granules OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 211708-003 Oct 31, 2019 AA RX No No ⤷  Try for Free ⤷  Try for Free
Granules PRAZOSIN HYDROCHLORIDE prazosin hydrochloride CAPSULE;ORAL 214608-003 Dec 23, 2021 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 6 of 6 entries
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Granules – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, Granules India Limited has emerged as a formidable player, carving out a unique niche for itself. This comprehensive analysis delves into Granules' market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Granules India: A Brief Overview

Granules India Limited, founded in 1984, has grown from a small API manufacturer to a fully integrated pharmaceutical powerhouse. The company specializes in the development, manufacturing, and distribution of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs)[5].

Core Products and Global Reach

Granules' core products include Paracetamol, Ibuprofen, Metformin, Guaifenesin, and Methocarbamol[5]. With a strong focus on exports, which now contribute over 94% of its overall business, Granules has established a significant global presence, particularly in regulated markets like the United States, Canada, and Europe[3].

Market Position and Competitive Advantages

Granules has strategically positioned itself as a vertically integrated pharmaceutical company, offering a comprehensive range of products across the value chain. This integration has allowed Granules to maintain a competitive edge in the market.

World-Class Manufacturing Capabilities

The company boasts some of the largest manufacturing facilities in the world:

  • One of the largest PFI and single-site FD facilities globally
  • The world's largest Paracetamol API facility[3]

These state-of-the-art facilities enable Granules to achieve economies of scale and maintain high-quality standards, crucial factors in the competitive pharmaceutical landscape.

Innovation and R&D Focus

Granules has demonstrated a strong commitment to innovation and research:

  • Two dedicated R&D centers in Hyderabad and Virginia
  • Additional R&D facilities in Pune and Pragathi Nagar (Hyderabad)[3]
  • Recently inaugurated integrated product Research and Development Centre at MN Park Genome Valley in Hyderabad, spanning 20,000 square feet[3]

This robust R&D infrastructure positions Granules at the forefront of pharmaceutical innovation, enabling the company to develop complex and innovative products.

"Granules has introduced some of the most influential manufacturing and operational innovations in the generics pharmaceutical industry. It excels in adapting ideas from other large-scale manufacturing industries to expand and enhance its pharmaceutical operations, while maintaining regulatory compliance."[1]

Strategic Growth Initiatives

Granules has implemented several strategic initiatives to drive growth and strengthen its market position:

Expansion into High-Value Segments

In 2017, Granules began a major strategic expansion by:

  • Opening a Virginia-based research and development facility
  • Developing a portfolio of lower-volume, higher-premium medicines, especially Extended Release Controlled substances[1]

This move into higher-value segments has allowed Granules to diversify its product portfolio and tap into new revenue streams.

Focus on Key Therapeutic Areas

Granules is actively building its presence in key therapeutic areas:

  • CNS and ADHD: Investments in US manufacturing arm showing promising results
  • Oncology: Plans to build a new oncology API manufacturing facility and increase finished dosage capacity[2]

By focusing on these high-growth therapeutic areas, Granules is positioning itself for future market opportunities.

Financial Performance and Market Share

Granules has demonstrated consistent financial growth over the years:

  • As of 2023, the company's US formulations sales exceeded $250 million[6]
  • The Finished Dosages (FD) segment now contributes over 50% of revenue[3]

This financial performance underscores Granules' strong market position and successful execution of its growth strategies.

Competitive Landscape and Market Challenges

While Granules has established a strong market position, it faces competition from other pharmaceutical companies with overlapping product portfolios:

Key Competitors

  • Aurobindo Pharma: Has the most products overlapping with Granules, including acetaminophen, ER metformin, ibuprofen, fexofenadine, and guaifenesin ER[6]
  • Marksans Pharma: Has approved ANDAs for nearly 45% of the analyzed SKUs[6]
  • Dr. Reddy's Laboratories: Also competes in similar product categories[6]

Market Challenges

Granules faces several challenges in the competitive pharmaceutical landscape:

  • Price erosion in key markets
  • Regulatory scrutiny and compliance requirements
  • Need for continuous innovation to stay ahead of competitors

Strategic Insights and Future Outlook

To maintain its competitive edge and drive future growth, Granules is focusing on several key areas:

1. R&D Investment

Granules has increased its R&D spending to Rs 620 million for the quarter, with plans for further investments[2]. This focus on R&D is crucial for developing complex and innovative products, including enzyme-based manufacturing technology.

2. Capacity Expansion

The company is expanding its production capacity and optimizing operations to enhance its position in key segments[2]. This includes the recent launch of a new greenfield packaging facility in Virginia.

3. Diversification into High-Value Segments

Granules is actively diversifying into high-value segments such as oncology and CNS/ADHD medications. This strategy aims to reduce dependence on traditional high-volume, low-margin products.

4. Global Market Expansion

With exports now contributing over 94% of overall business, Granules continues to focus on strengthening its presence in regulated markets, particularly the United States[3].

5. Operational Excellence

Granules has turned efficiency and operational effectiveness into a baseline for growth, similar to the Japanese auto industry in the 1970s[1]. This focus on operational excellence provides a safety net for large investments and helps maintain competitiveness.

SWOT Analysis

Strengths

  • Vertically integrated operations
  • World-class manufacturing facilities
  • Strong R&D capabilities
  • Established presence in regulated markets
  • Diverse product portfolio across API, PFI, and FD segments

Weaknesses

  • Dependence on a few key products
  • Exposure to price erosion in generic markets
  • Regulatory risks in key markets

Opportunities

  • Expansion into high-value therapeutic areas
  • Growing demand for generic medications globally
  • Potential for strategic acquisitions or partnerships

Threats

  • Intense competition in the generic pharmaceutical market
  • Regulatory changes in key markets
  • Potential supply chain disruptions

Key Takeaways

  1. Granules has successfully positioned itself as a vertically integrated pharmaceutical company with a strong global presence.
  2. The company's focus on innovation, R&D, and operational excellence has been key to its competitive advantage.
  3. Granules is actively diversifying into high-value segments and expanding its presence in key therapeutic areas.
  4. While facing competition and market challenges, Granules' strategic initiatives and robust manufacturing capabilities position it well for future growth.
  5. Continuous investment in R&D and capacity expansion will be crucial for maintaining Granules' competitive edge in the evolving pharmaceutical landscape.

FAQs

  1. Q: What are Granules India's main product categories? A: Granules specializes in Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs), with core products including Paracetamol, Ibuprofen, Metformin, Guaifenesin, and Methocarbamol.

  2. Q: How has Granules India expanded its global presence? A: Granules has focused on exports, which now contribute over 94% of its overall business. The company has established a strong presence in regulated markets like the United States, Canada, and Europe.

  3. Q: What are some of Granules India's key competitive advantages? A: Granules' main competitive advantages include its vertically integrated operations, world-class manufacturing facilities, strong R&D capabilities, and operational excellence.

  4. Q: How is Granules India addressing market challenges? A: Granules is addressing market challenges through increased R&D investment, capacity expansion, diversification into high-value segments, and a continued focus on operational excellence.

  5. Q: What are the future growth areas for Granules India? A: Granules is focusing on expanding its presence in key therapeutic areas such as CNS, ADHD, and oncology, while also developing complex and innovative products through its enhanced R&D capabilities.

Sources cited: [1] https://www.ifc.org/en/insights-reports/2021/granules-cases-study [2] https://www.equitymaster.com/detail.asp?date=09%2F13%2F2024&story=3&title=Why-Granules-India-Share-Price-is-Falling [3] https://www.hdfcsec.com/hsl.research.pdf/HSL_Stock%20Note%20-%20Granules%20India%20-%20150124%20Signed.pdf [5] https://www.globaldata.com/company-profile/granules-india-ltd/ [6] https://www.cnbctv18.com/market/granules-india-share-price-gagillapur-oai-status-impact-pharma-cos-product-overlap-19518951.htm

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