Encube Ethicals Private Limited

Encube Ethicals Private Limited, established on September 7, 1995, is a privately held pharmaceutical company headquartered in Mumbai, Maharashtra, India. The company specializes in the manufacture of finished pharmaceutical formulations, focusing on topical preparations such as creams, ointments, gels, lotions, and solutions. Its Corporate Identification Number (CIN) is U24230MH1995PTC092485.

As of March 2026, Encube Ethicals has an authorized capital of ₹150 crore and a paid-up capital of ₹101.27 crore. The company is led by a team of directors, including Mehul Madhusudan Shah (Managing Director), Nilesh Navinchandra Maniar, Amit Varma, Madhusudan Nyalchand Shah, Himanshu Mahendra Gandhi, and Jinaraja Sanjeeva Poojary. The company employs between 250 to 500 individuals, reflecting its significant presence in the pharmaceutical manufacturing sector.

Encube Ethicals operates a state-of-the-art manufacturing facility in Goa, India, dedicated exclusively to dermatological products. This plant, commissioned in March 1998, is approved by international regulatory bodies, including the Health Products and Food Branch Inspectorate (HPFBI) of Canada and the Therapeutic Goods Administration (TGA) of Australia. Additionally, the facility holds WHO-GMP certification, ISO 9001:2000 certification, and the IDMA Quality Excellence Gold Award for 2004.

The leadership team at Encube Ethicals is headed by Managing Director Mehul Madhusudan Shah, who has been with the company since its inception in 1995. Other key directors include Nilesh Navinchandra Maniar (appointed January 30, 2002), Amit Varma (appointed June 28, 2021), Madhusudan Nyalchand Shah (appointed September 7, 1995), Himanshu Mahendra Gandhi (appointed January 30, 2002), and Jinaraja Sanjeeva Poojary (appointed November 26, 2025).

Encube Ethicals has established a strong presence in regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's manufacturing facility in Goa holds approvals from the Health Products and Food Branch Inspectorate (HPFBI) of Canada and the Therapeutic Goods Administration (TGA) of Australia, indicating compliance with international standards. While specific regulatory filings and approvals in the U.S., EU, UK, and Japan are not detailed in the available sources, the company's adherence to WHO-GMP standards suggests a commitment to meeting the stringent requirements of these markets.

Encube Ethicals has made strategic inroads into emerging markets, including Africa, Latin America, and Southeast Asia. The company's WHO-GMP certification facilitates access to these regions, as it is recognized by the World Health Organization as a standard for quality manufacturing practices. This certification enhances the company's credibility and marketability in these developing markets.

Encube Ethicals demonstrates a diversified geographic strategy by establishing manufacturing facilities in Goa, India, and obtaining approvals from international regulatory bodies such as the HPFBI of Canada and the TGA of Australia. This approach mitigates concentration risk and positions the company to leverage opportunities in both developed and emerging markets.

Specific details regarding Encube Ethicals' FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not available in the provided sources. However, the company's adherence to WHO-GMP standards and approvals from other international regulatory bodies suggest a commitment to meeting global quality standards.

Encube Ethicals' manufacturing facility in Goa holds WHO-GMP certification, indicating compliance with the World Health Organization's Good Manufacturing Practices. While specific EU GMP certificates and EDQM status are not detailed in the available sources, the company's WHO-GMP certification suggests a foundation for obtaining EU GMP certifications, which are essential for market access in European Union countries.

Encube Ethicals holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. The company's manufacturing facility in Goa is approved by the HPFBI of Canada and the TGA of Australia, indicating compliance with international standards. Specific details regarding state drug controller approvals and export No Objection Certificates (NOCs) are not available in the provided sources.

There are no specific records of Form 483 observations, warning letters, or import alerts for Encube Ethicals in the available sources. The company's adherence to WHO-GMP standards and approvals from international regulatory bodies suggest a strong compliance record.

Encube Ethicals operates in the dermatological pharmaceutical sector, competing with other companies specializing in topical formulations. While specific market share comparisons are not available in the provided sources, the company's WHO-GMP certification and international approvals position it favorably in the market.

Encube Ethicals' exclusive focus on dermatological products, combined with its state-of-the-art manufacturing facility in Goa and international certifications, distinguishes it in the pharmaceutical manufacturing sector. The company's commitment to quality is evidenced by its WHO-GMP certification and approvals from regulatory bodies such as the HPFBI of Canada and the TGA of Australia.

Encube Ethicals maintains a strategic focus on dermatological products, leveraging its specialized manufacturing facility and international certifications to serve both developed and emerging markets. The company's adherence to WHO-GMP standards and approvals from regulatory bodies such as the HPFBI of Canada and the TGA of Australia underscore its commitment to quality and regulatory compliance.

Encube Ethicals demonstrates a strong track record in pharmaceutical manufacturing, with a focus on dermatological products. The company's manufacturing facility in Goa is approved by international regulatory bodies, including the HPFBI of Canada and the TGA of Australia, indicating reliability and adherence to global quality standards.

Importers should verify the following certifications to ensure product quality and regulatory compliance:

• WHO-GMP Certification: Indicates compliance with the World Health Organization's Good Manufacturing Practices.

• ISO 9001:2000 Certification: Demonstrates adherence to quality management standards.

• Regulatory Approvals: Confirm approvals from relevant authorities such as the HPFBI of Canada and the TGA of Australia.

When engaging with Encube Ethicals, consider the following steps:

• Verify Certifications: Ensure the company holds valid WHO-GMP and ISO certifications.

• Assess Regulatory Approvals: Confirm approvals from relevant authorities such as the HPFBI of Canada and the TGA of Australia.

• Evaluate Manufacturing Capabilities: Review the company's manufacturing facility and its compliance with international standards.

• Review Financial Performance: Analyze the company's financial statements for insights into its stability and growth trajectory.

• Check Compliance Records: Investigate any past regulatory actions or compliance issues.

By conducting thorough due diligence, importers can ensure a reliable and compliant partnership with Encube Ethicals.