Sentiss Pharma Private Limited

Sentiss Pharma Private Limited, established on January 13, 1994, is a privately held pharmaceutical company headquartered in New Delhi, India. The company is registered under the Corporate Identification Number (CIN) U74899DL1994PTC056894. As of March 31, 2025, Sentiss Pharma reported an authorized capital of ₹10.00 crore and a paid-up capital of ₹5.88 crore. The company operates in the pharmaceutical manufacturing sector, focusing on the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. Sentiss Pharma employs approximately 689 professionals as of March 31, 2023. The company's registered office is located at 212 Ashirwad Commercial Complex, D-I Green Park, New Delhi, Delhi 110016, India.

Sentiss Pharma operates two sterile manufacturing facilities: one in India and another in Switzerland. The Indian facility is situated in Gurgaon, Haryana, and specializes in the production of ophthalmic, inhalation, and specialty pharmaceutical products. The Swiss facility, acquired through the purchase of Akorn AG, is US FDA-approved and focuses on the manufacturing of ophthalmic eye drops and ointments. These facilities are equipped with state-of-the-art technology to ensure the production of high-quality pharmaceutical formulations.

The leadership team at Sentiss Pharma includes:

• Deepak Bahri: Managing Director

• Canakapalli Bhaktavatasala Rao: Director

• Mahesh Kumar Garg: Director

• Geeta Mathur: Director

• Pratik Nupendrakumar Shah: Director

• Rishi Kapoor: Director

These individuals play pivotal roles in steering the company's strategic direction and operations.

Sentiss Pharma has made significant strides in regulated markets, particularly in the United States. The acquisition of Akorn AG in Switzerland has enhanced the company's capabilities, providing access to a US FDA-approved manufacturing facility for ophthalmic products. This facility produces ophthalmic eye drops and ointments, adhering to stringent FDA standards. While specific details regarding regulatory filings and approvals in the European Union, United Kingdom, Australia, and Japan are not publicly disclosed, the company's expansion into these markets is facilitated by its adherence to international quality standards and certifications.

Sentiss Pharma has a notable presence in emerging markets, including Russia, where it has become the largest ophthalmic company. The company's expansion into Russia is supported by its acquisition of Akorn AG, which provides a US FDA-approved manufacturing facility for ophthalmic products. Additionally, Sentiss Pharma has operations in regions such as the United States, Europe, Dubai, Russia, and Central Asia, indicating a strategic approach to penetrating diverse markets. The company's commitment to quality and regulatory compliance positions it favorably for accessing markets with WHO prequalification requirements.

Sentiss Pharma's geographic strategy demonstrates a balanced approach to market diversification. The company's significant presence in Russia, where it has become the largest ophthalmic company, reflects a successful penetration into the Eastern European market. The acquisition of Akorn AG in Switzerland has provided access to a US FDA-approved manufacturing facility, facilitating entry into the North American market. Operations in Europe, Dubai, Russia, and Central Asia further diversify the company's market presence. This strategic diversification mitigates concentration risk and positions Sentiss Pharma to leverage growth opportunities across various regions.

Sentiss Pharma's acquisition of Akorn AG in Switzerland has provided access to a US FDA-approved manufacturing facility for ophthalmic products. This facility produces ophthalmic eye drops and ointments, adhering to stringent FDA standards. While specific details regarding FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly disclosed, the company's adherence to international quality standards and certifications indicates a commitment to regulatory compliance in the US market.

Sentiss Pharma's manufacturing facilities are equipped with state-of-the-art technology to ensure the production of high-quality pharmaceutical formulations. The company's acquisition of Akorn AG in Switzerland has provided access to a US FDA-approved manufacturing facility for ophthalmic products. While specific details regarding WHO prequalification and EU Good Manufacturing Practice (GMP) certificates are not publicly disclosed, the company's expansion into regulated markets suggests adherence to international quality standards and certifications.

Sentiss Pharma operates in compliance with the regulations set forth by the Central Drugs Standard Control Organisation (CDSCO) in India. The company's manufacturing facilities are equipped with state-of-the-art technology to ensure the production of high-quality pharmaceutical formulations. While specific details regarding CDSCO manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not publicly disclosed, the company's adherence to international quality standards and certifications indicates a commitment to regulatory compliance in the Indian market.

As of March 28, 2026, there are no publicly available records indicating any Form 483 observations, warning letters, or import alerts issued to Sentiss Pharma Private Limited. The company's adherence to international quality standards and certifications suggests a proactive approach to regulatory compliance.

Sentiss Pharma operates in a competitive pharmaceutical market, particularly in the ophthalmic segment. While specific market share data is not publicly disclosed, the company's expansion into Russia, where it has become the largest ophthalmic company, indicates a strong competitive position in that market. The acquisition of Akorn AG in Switzerland has provided access to a US FDA-approved manufacturing facility for ophthalmic products, enhancing the company's competitive edge in the North American market. The company's operations in Europe, Dubai, Russia, and Central Asia further diversify its market presence, allowing it to compete effectively across various regions.

Sentiss Pharma's key differentiators include its focus on ophthalmic, inhalation, and specialty pharmaceutical products, supported by a state-of-the-art R&D center in India and two sterile manufacturing facilities in India and Switzerland. The acquisition of Akorn AG has provided access to a US FDA-approved manufacturing facility for ophthalmic products, enhancing the company's capabilities in the ophthalmic segment. The company's commitment to quality and regulatory compliance positions it favorably in both regulated and emerging markets.

Sentiss Pharma's strategic direction focuses on the development and manufacturing of ophthalmic, inhalation, and specialty pharmaceutical products. The company's acquisition of Akorn AG in Switzerland has provided access to a US FDA-approved manufacturing facility for ophthalmic products, facilitating entry into the North American market. The company's operations in Europe, Dubai, Russia, and Central Asia further diversify its market presence. Looking ahead, Sentiss Pharma is well-positioned to leverage its manufacturing capabilities and market presence to drive growth in the global pharmaceutical industry.

Sentiss Pharma has demonstrated a strong track record in the pharmaceutical industry, with a focus on ophthalmic, inhalation, and specialty products. The company's acquisition of Akorn AG in Switzerland has provided access to a US FDA-approved manufacturing facility for ophthalmic products, enhancing its capabilities in the ophthalmic segment. The company's operations in Europe, Dubai, Russia, and Central Asia further diversify its market presence. While specific export volumes and consistency are not publicly disclosed, the company's adherence to international quality standards and certifications indicates reliability as a supplier.

Importers should verify the following certifications when considering Sentiss Pharma as a supplier:

• FDA Approval: Confirm that the manufacturing facility is registered with the US Food and Drug Administration (FDA) and that products are listed in the FDA's Drug Establishments Current Registration System (DECRS).

• WHO-GMP Certification: Ensure that the manufacturing facility complies with the World Health Organization's Good Manufacturing Practice (GMP) standards.

• EU GMP Certification: Verify that the manufacturing facility adheres to the European Union's Good Manufacturing Practice (GMP) standards.

• ISO Certification: Check for