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Last Updated: May 20, 2025

Annora Pharma Company Profile


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What is the competitive landscape for ANNORA PHARMA

ANNORA PHARMA has forty-four approved drugs.

There are six tentative approvals on ANNORA PHARMA drugs.

Summary for Annora Pharma
US Patents:0
Tradenames:37
Ingredients:37
NDAs:44
Patent Litigation for Annora Pharma: See patent lawsuits for Annora Pharma

Drugs and US Patents for Annora Pharma

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Annora Pharma MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 216463-002 Nov 9, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free
Annora Pharma IBUPROFEN ibuprofen SUSPENSION;ORAL 210602-001 Nov 23, 2018 OTC No No ⤷  Try for Free ⤷  Try for Free
Annora Pharma DARUNAVIR darunavir TABLET;ORAL 216168-002 Jan 21, 2025 AB RX No No ⤷  Try for Free ⤷  Try for Free
Annora Pharma BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 216800-001 May 31, 2023 AB1 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
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Annora Pharma – Market Position, Strengths & Strategic Insights

In the dynamic world of pharmaceuticals, understanding the competitive landscape is crucial for success. Annora Pharma, a relatively young player in the industry, has been making significant strides since its establishment in 2016. This analysis delves into Annora Pharma's market position, strengths, and strategic insights, providing a comprehensive view of its place in the pharmaceutical competitive landscape.

Company Overview

Annora Pharma Private Limited, founded in 2016, has quickly established itself as a notable player in the pharmaceutical industry[6]. The company specializes in manufacturing a wide range of pharmaceutical products, including tablets, capsules, pellets, liquid orals, suppositories, and dry powder syrups[6]. With its state-of-the-art manufacturing facility spread across 35 acres near Hyderabad, India, Annora Pharma has positioned itself as a quality-focused, innovative pharmaceutical manufacturer[6].

Market Position

Global Presence

Annora Pharma has made significant strides in expanding its global footprint. The company's products are present in over 126 countries, showcasing its strong international market penetration[1]. This wide geographical reach positions Annora Pharma as a global player in the pharmaceutical industry, capable of competing with established multinational corporations.

Product Portfolio

Annora Pharma boasts a strong product portfolio comprising more than 30 products across multiple therapeutic segments[1]. This diverse range includes treatments for:

  • HIV and AIDS (ARVs)
  • Anti-hyperlipidaemic
  • Anti-hypertensive
  • Anti-epileptic
  • Anti-muscarinic
  • Antihistamine
  • Anti-viral
  • Idiopathic pulmonary fibrosis
  • Antidepressant
  • Neurogenic orthostatic hypotension
  • Chronic ulcerative proctitis
  • Anti-cholinergic[1]

The company's ability to cater to various therapeutic areas demonstrates its versatility and potential for growth in different market segments.

Manufacturing Capabilities

Annora Pharma's manufacturing facility is designed to meet stringent international standards, including:

  • Schedule M of Indian Drugs & Cosmetics Act
  • USFDA guidelines
  • European Regulatory Agency's Guidelines
  • Current Good Manufacturing Practices (cGMP)[6]

This adherence to global standards enhances the company's credibility and opens doors to regulated markets worldwide.

Strengths and Competitive Advantages

Rapid Growth and Financial Performance

Annora Pharma has demonstrated impressive financial growth since its inception. The company's total operating income (TOI) has grown by an average of 25% between FY22 and H1FY24[1]. This consistent growth trajectory indicates strong market demand for Annora Pharma's products and effective business strategies.

Strategic Importance to Parent Company

As part of the Hetero group, which has a presence in over 126 countries and more than 36 manufacturing units, Annora Pharma benefits from the group's extensive experience and resources[1]. This association provides Annora Pharma with strategic advantages in terms of market access, technology transfer, and operational synergies.

Focus on Research and Development

Annora Pharma has shown a strong commitment to research and development, particularly in the area of Abbreviated New Drug Applications (ANDAs). The company has filed a total of 75 ANDAs to date, with 40 receiving approvals and 35 under review[1]. This focus on R&D and new product development positions Annora Pharma as an innovative player in the generic pharmaceutical market.

"APPL will reportedly file about 10-12 ANDAs each year, going forward."[1]

This aggressive ANDA filing strategy indicates Annora Pharma's commitment to expanding its product portfolio and capturing new market opportunities.

Quality Assurance and Regulatory Compliance

Annora Pharma's manufacturing facility is designed to meet international quality standards, including USFDA and European Regulatory Agency guidelines[6]. This focus on quality and compliance enhances the company's reputation and opens doors to regulated markets worldwide.

Diversified Product Portfolio

The company has successfully diversified its product portfolio, reducing dependence on a few key products. For instance, the contribution of its top two products (DLT and levetiracetam) to total revenue decreased from 78% in FY21 to about 40% in FY23 and H1FY24[1]. This diversification strategy mitigates risks associated with product concentration and enhances the company's resilience to market fluctuations.

Strategic Insights

Focus on High-Growth Therapeutic Areas

Annora Pharma's product portfolio spans multiple therapeutic segments, with a focus on high-growth areas such as anti-retroviral, anti-epileptic, and anti-hypertensive drugs[1]. By targeting these segments, the company positions itself to capitalize on growing market demand and evolving healthcare needs.

Continuous Innovation and Product Development

The company's strategy of filing 10-12 ANDAs each year demonstrates its commitment to continuous innovation and product development[1]. This approach allows Annora Pharma to stay ahead of market trends and maintain a competitive edge in the generic pharmaceutical space.

Leveraging Parent Company's Strengths

As part of the Hetero group, Annora Pharma can leverage its parent company's extensive global presence and manufacturing capabilities[1]. This association provides opportunities for knowledge sharing, technology transfer, and market access that can accelerate Annora Pharma's growth.

Quality-Driven Approach

Annora Pharma's focus on maintaining high-quality standards and regulatory compliance positions it well in the competitive pharmaceutical landscape. This quality-driven approach is crucial for building trust with healthcare providers, patients, and regulatory authorities.

Challenges and Areas for Improvement

Limited Operational Track Record

As a relatively young company, Annora Pharma has a limited operational track record compared to more established players in the industry[1]. This could potentially impact investor confidence and partnerships in the short term.

Geographical and Customer Concentration Risks

While Annora Pharma has a presence in over 126 countries, there may be risks associated with geographical concentration in certain markets[1]. Diversifying its customer base and expanding into new markets could help mitigate these risks.

Regulatory Exposure

The pharmaceutical industry is subject to stringent regulatory requirements, which can pose challenges and risks to companies like Annora Pharma[1]. Staying ahead of regulatory changes and maintaining compliance across multiple markets will be crucial for the company's long-term success.

Intense Competition and Pricing Pressure

The generic pharmaceutical market is characterized by intense competition and pricing pressure[1]. Annora Pharma will need to continually innovate and optimize its operations to maintain profitability in this challenging environment.

Future Outlook and Growth Opportunities

Expanding Product Pipeline

With its focus on ANDA filings and new product development, Annora Pharma is well-positioned to expand its product pipeline in the coming years[1]. This expansion can drive growth and help the company capture new market opportunities.

Penetration of Regulated Markets

Annora Pharma's USFDA-approved manufacturing plant opens doors to regulated markets, particularly the lucrative US generic drug market[1]. Increasing its presence in these markets can significantly boost the company's revenue and market share.

Strategic Partnerships and Collaborations

Forming strategic partnerships with other pharmaceutical companies, research institutions, or healthcare providers could help Annora Pharma accelerate its growth and expand its capabilities.

Focus on Specialty Pharmaceuticals

As the generic drug market becomes increasingly competitive, Annora Pharma could consider expanding its focus on specialty pharmaceuticals, which often offer higher margins and face less competition.

Key Takeaways

  1. Annora Pharma has rapidly established itself as a notable player in the pharmaceutical industry since its founding in 2016.

  2. The company's strong product portfolio, spanning multiple therapeutic segments, positions it well in the competitive landscape.

  3. Annora Pharma's focus on research and development, particularly in ANDA filings, demonstrates its commitment to innovation and growth.

  4. The company's state-of-the-art manufacturing facility and adherence to international quality standards enhance its credibility in global markets.

  5. As part of the Hetero group, Annora Pharma benefits from strategic advantages in terms of market access and operational synergies.

  6. Challenges include a limited operational track record, potential geographical concentration risks, and intense competition in the generic drug market.

  7. Future growth opportunities lie in expanding the product pipeline, penetrating regulated markets, and potentially exploring specialty pharmaceuticals.

FAQs

  1. Q: What are Annora Pharma's main therapeutic areas of focus? A: Annora Pharma focuses on multiple therapeutic areas, including HIV and AIDS (ARVs), anti-epileptic, anti-hypertensive, anti-viral, and antidepressant treatments, among others.

  2. Q: How many ANDAs has Annora Pharma filed to date? A: As of the latest available information, Annora Pharma has filed a total of 75 ANDAs, with 40 receiving approvals and 35 under review.

  3. Q: What is Annora Pharma's strategy for product diversification? A: Annora Pharma has successfully reduced its dependence on top products, with the contribution of its two leading products decreasing from 78% in FY21 to about 40% in FY23 and H1FY24.

  4. Q: How does Annora Pharma ensure quality in its manufacturing processes? A: Annora Pharma's manufacturing facility is designed to meet international standards, including USFDA and European Regulatory Agency guidelines, as well as current Good Manufacturing Practices (cGMP).

  5. Q: What are the main challenges facing Annora Pharma in the competitive pharmaceutical landscape? A: Key challenges include a limited operational track record, potential geographical concentration risks, regulatory exposure, and intense competition and pricing pressure in the generic drug market.

Sources cited:

  1. https://www.careratings.com/upload/CompanyFiles/PR/202402130244_Annora_Pharma_Private_Limited.pdf
  2. https://www.annorapharma.com
Last updated: 2025-02-13

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