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Last Updated: April 14, 2025

Encube Company Profile


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What is the competitive landscape for ENCUBE

ENCUBE has sixty-one approved drugs.



Summary for Encube
US Patents:0
Tradenames:41
Ingredients:40
NDAs:61
PTAB Cases with Encube as petitioner: See PTAB cases with Encube as petitioner

Drugs and US Patents for Encube

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Encube ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 206164-001 May 23, 2018 AB RX No No ⤷  Try for Free ⤷  Try for Free
Encube CLINDAMYCIN PHOSPHATE AND TRETINOIN clindamycin phosphate; tretinoin GEL;TOPICAL 216943-001 Sep 1, 2023 AB2 RX No No ⤷  Try for Free ⤷  Try for Free
Encube MOMETASONE FUROATE mometasone furoate OINTMENT;TOPICAL 076481-001 Nov 14, 2003 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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Pharmaceutical Competitive Landscape Analysis: Encube – Market Position, Strengths & Strategic Insights

In the dynamic world of pharmaceutical manufacturing, Encube Ethicals has emerged as a significant player, particularly in the realm of topical formulations. This comprehensive analysis delves into Encube's market position, strengths, and strategic insights, offering a detailed look at how this Indian pharmaceutical company is making waves in the global market.

Encube Ethicals: An Overview

Encube Ethicals, founded in 1998 by Mehul Shah, has established itself as an integrated pharmaceutical company specializing in topical formulations[1][3]. With over two decades of experience, Encube has grown from a small start-up to a global player in the pharmaceutical industry.

Key Facts:

  • Founded: 1998
  • Headquarters: Mumbai, India
  • Manufacturing Facility: Madkaim, Goa
  • Employees: Approximately 1,400
  • Global Reach: Over 30 countries
  • Product Portfolio: 400+ SKUs

Market Position and Global Presence

Encube's market position has strengthened significantly over the years, with the company now touching nearly 100 million lives globally[2]. Its presence spans across multiple continents, serving markets from the United States to Japan, Europe, Brazil, the Middle East, Africa, and Southeast Asia.

CDMO Services

Encube's Contract Development and Manufacturing Organization (CDMO) division serves over 30 countries globally. This business model allows Encube to manufacture topical brands for major pharmaceutical companies like Bayer, Galderma, Sanofi, and Reckitt[2].

U.S. Generics Market

In the U.S. generics market, Encube has made remarkable progress:

  • Became the fifth-largest topical supplier by volume in just seven years
  • Filed and received approval for over 50 Abbreviated New Drug Applications (ANDAs)
  • Aims to be among the top three players in the next two years[2]

Indian Market

Encube launched operations in the Indian market in 2022, focusing on developing a comprehensive OTC & wound care portfolio[2].

Manufacturing Capabilities and Infrastructure

Encube's manufacturing prowess is a significant contributor to its market position.

World-Class Manufacturing Facility

Encube's facility in Goa is one of the largest single-site topical manufacturing facilities in the world, dedicated to prescription and OTC pharmaceuticals, and cosmetic semisolid dosage forms[1].

Key features of the manufacturing facility:

  • Capacity: 500+ million units annually
  • Built-up Area: 30,588 m²
  • Land: 56,419 m²
  • Investment: Over $40 million USD[5]

High Potency Topical Manufacturing Suite

In 2019, Encube invested $4 million to bolster its topical manufacturing capabilities:

  • 350 m² facility in Goa
  • In-house isolator technology for HPAPIs
  • ISO Class 7 classification for core manufacturing areas[6]

Research and Development

Encube's commitment to innovation is evident in its robust R&D infrastructure.

R&D Center

  • Location: Mumbai, India
  • Team: 150+ scientists
  • Focus: Formulation development of topical products[1]

R&D Capabilities

  • Formulation Lab: 3,600 sq ft with a 15-member team
  • Analytical Lab: 1,800 sq ft with a 25-member team
  • ISO class 8 Pilot Area for trial batch manufacturing
  • Potential to work on 10+ new ANDAs annually[5]

Product Portfolio and Therapeutic Areas

Encube's product portfolio is diverse, focusing primarily on topical formulations.

Product Range

  • Prescription pharmaceuticals
  • Over-the-counter (OTC) products
  • Cosmetic semisolid dosage forms[1]

Therapeutic Focus

  • Dermatology
  • Wound care
  • Topical pain management

Recent Acquisitions

In 2021, Encube acquired the popular topical anti-microbial brand Soframycin and other associated brands from Sanofi for the India and Sri Lanka markets, marking its entry into branded products in these regions[10].

Competitive Advantages

Several factors contribute to Encube's competitive edge in the pharmaceutical landscape.

Specialization in Topical Formulations

Encube's singular focus on semisolid formulations has allowed it to develop deep expertise in this niche area[5].

Scale and Cost-Effectiveness

The large-scale manufacturing facility in Goa enables Encube to achieve economies of scale, keeping costs low and passing savings to partners and customers[2].

Innovation Focus

Despite operating mainly in the generics industry, Encube invests heavily in R&D, focusing on challenging and unique products[2].

Quality Standards

Encube maintains high-quality standards across all product lines, regardless of the target market[2].

Strategic Insights and Future Outlook

Encube's strategic direction reveals a company poised for continued growth and innovation.

Expansion Plans

  • Aiming for a top 3 position in the U.S. generics market within two years[2]
  • Developing a comprehensive OTC & wound care portfolio for the Indian market[2]

Innovation-Driven Strategy

Encube's success hinges on a commitment to affordability without compromising quality, backed by substantial R&D investments[2].

Sustainability Focus

The company sees India evolving into a value-based ecosystem, with a focus on accessibility and sustainability[2].

AI-Driven Manufacturing

Encube envisions high potential for India as an AI-driven manufacturing hub for the world[2].

Challenges and Competition

While Encube has shown impressive growth, it faces several challenges in the competitive pharmaceutical landscape.

Generic Market Pressures

The generic drug market is highly competitive, with pressure on pricing and margins.

Regulatory Hurdles

Navigating complex regulatory environments across multiple countries requires significant resources and expertise.

Innovation Race

Staying ahead in terms of product innovation and manufacturing efficiency is crucial in the fast-paced pharmaceutical industry.

Key Takeaways

  1. Encube Ethicals has established itself as a global leader in topical formulations, with a strong presence in over 30 countries.

  2. The company's world-class manufacturing facility in Goa, coupled with its robust R&D center in Mumbai, provides a strong foundation for growth and innovation.

  3. Encube's strategic focus on CDMO services, U.S. generics, and the Indian market demonstrates a diversified approach to market penetration.

  4. The acquisition of brands like Soframycin marks Encube's entry into branded products in the Indian market, signaling a new phase of growth.

  5. Encube's commitment to innovation, quality, and cost-effectiveness positions it well for future growth in the competitive pharmaceutical landscape.

FAQs

  1. What is Encube Ethicals' primary area of expertise? Encube Ethicals specializes in topical formulations, including prescription pharmaceuticals, OTC products, and cosmetic semisolid dosage forms.

  2. How many countries does Encube Ethicals serve? Encube serves over 30 countries globally, spanning North America, Europe, Asia, Africa, and the Middle East.

  3. What is the capacity of Encube's manufacturing facility in Goa? The Goa facility has a capacity to produce over 500 million units annually, making it one of the largest single-site topical manufacturing facilities in the world.

  4. How many ANDAs has Encube filed and received approval for in the U.S.? Encube has filed and received approval for over 50 Abbreviated New Drug Applications (ANDAs) in the U.S. market.

  5. What recent acquisition has Encube made to enter the branded products market in India? In 2021, Encube acquired the topical anti-microbial brand Soframycin and other associated brands from Sanofi for the India and Sri Lanka markets.

Sources cited:

  1. https://leadiq.com/c/encube-ethicals/601111cc881cc9057f878ab2
  2. https://www.executiveforecast.com/conversation/success-through-quality-innovation-and-patient-centricity-interview-with-amish-desai---associate-vice-president-encube-india
  3. https://www.worldpharmatoday.com/production-manufacturing/encube-ethicals-announces-new-high-potency-topical-manufacturing-suite/
  4. https://www.encubeusa.com/Corporate-Brochure.pdf
  5. https://cleanroomtechnology.com/encube-ethicals-opens-new-topical-manufacturing-facility-188874
  6. https://economictimes.com/industry/healthcare/biotech/pharmaceuticals/encube-ethicals-to-buy-soframycin-for-rs-125-crore-for-india-sl-markets/articleshow/87930028.cms

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