Kausikh Therapeutics Private Limited

Kausikh Therapeutics Private Limited, established on April 19, 2000, is a privately held pharmaceutical company headquartered in Gerugambakkam, Tamil Nadu, India. The company specializes in the manufacture of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections, catering to both domestic and international markets. With an authorized and paid-up capital of ₹5.00 crore, Kausikh Therapeutics operates as a non-government company under the Corporate Identification Number (CIN) U24232TN2000PTC044776.

The company's manufacturing facility is located at No. 6 & 7, Door No. 728, Kakkanji Cross Street, Paraniputhur Road, Gerugambakkam, Tamil Nadu, 600122. Kausikh Therapeutics employs approximately 161 professionals, reflecting its commitment to quality and operational excellence. The company's website, www.kausikh.com, provides further insights into its product offerings and corporate philosophy.

Kausikh Therapeutics operates a state-of-the-art manufacturing plant in Gerugambakkam, Tamil Nadu, which adheres to stringent current Good Manufacturing Practice (cGMP) guidelines. This facility is equipped to produce a wide range of advanced and finished dosage forms, including tablets, capsules, syrups, and injections. The company's emphasis on quality is evident in its commitment to meeting world-class standards, satisfying norms for multinational and large pharmaceutical companies.

The leadership team at Kausikh Therapeutics comprises:

• Vaidhyanathen Neelakantan: Managing Director, appointed on April 19, 2000.

• Vaidhyanathan Ramasubrahmanian: Director, appointed on April 19, 2000.

• Anantharamkrishnan Vaidhyanathen: Director, appointed on April 19, 2000.

These individuals have been instrumental in steering the company towards its current position in the pharmaceutical industry.

Kausikh Therapeutics has established a presence in various regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has undertaken regulatory filings and approvals to access these markets, demonstrating its commitment to meeting international standards. While specific details of these approvals are not publicly disclosed, the company's adherence to cGMP guidelines and its focus on quality manufacturing suggest a proactive approach to regulatory compliance.

Kausikh Therapeutics has expanded its reach into emerging markets across Africa, Latin America, and Southeast Asia. The company's commitment to quality and adherence to international standards, such as cGMP, positions it favorably for WHO prequalification, which is essential for accessing these markets. By focusing on quality and compliance, Kausikh Therapeutics aims to meet the growing demand for pharmaceutical products in these regions.

Kausikh Therapeutics has strategically diversified its geographic footprint by entering both regulated and emerging markets. This approach mitigates concentration risk and leverages growth opportunities across different regions. The company's focus on quality manufacturing and adherence to international standards supports its strategic direction, enabling it to cater to a broad spectrum of markets.

Specific details regarding Kausikh Therapeutics' FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly available. However, the company's commitment to quality manufacturing and adherence to cGMP guidelines suggest a proactive approach to meeting FDA standards. The absence of publicly available information may indicate that the company is in the process of obtaining or maintaining FDA approvals.

Kausikh Therapeutics' adherence to stringent cGMP guidelines indicates a commitment to quality manufacturing. While specific certifications such as WHO prequalification and EU Good Manufacturing Practice (GMP) certificates are not publicly disclosed, the company's focus on quality and compliance suggests that it is well-positioned to meet the requirements for these certifications. Achieving such certifications would further validate the company's manufacturing practices and facilitate access to international markets.

Kausikh Therapeutics holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. The company's compliance with CDSCO regulations ensures that its products meet the required quality and safety standards for both domestic and international markets. Specific details regarding state drug controller approvals and export No Objection Certificates (NOCs) are not publicly available. However, the company's adherence to cGMP guidelines and its focus on quality manufacturing suggest a proactive approach to meeting all regulatory requirements.

As of March 28, 2026, there are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Kausikh Therapeutics. This absence suggests that the company maintains a strong compliance record with regulatory authorities. The company's commitment to quality manufacturing and adherence to cGMP guidelines further support this positive compliance status.

Kausikh Therapeutics operates in a competitive pharmaceutical industry, with numerous companies offering similar products in the vitamins & supplements and cardiovascular therapeutic categories. While specific market share data is not publicly available, the company's focus on quality manufacturing and adherence to international standards positions it favorably in the market. The absence of publicly available information on top competitors and their market shares suggests that Kausikh Therapeutics may not be a market leader in its categories.

Kausikh Therapeutics' key differentiators include its commitment to quality manufacturing, adherence to cGMP guidelines, and a diverse product portfolio encompassing vitamins & supplements and cardiovascular products. The company's focus on contract research and customer-oriented manufacturing systems allows it to offer formulations in various languages and third-party names, catering to client specifications.

Kausikh Therapeutics' current strategic direction focuses on contract research and manufacturing services, offering both generic products developed in-house and contract manufacturing services to pharmaceutical marketing companies. This approach allows the company to cater to a broad spectrum of market needs, from generic formulations to customized manufacturing solutions. The company's commitment to quality and adherence to international standards positions it well for future growth and expansion in both domestic and international markets.

Kausikh Therapeutics has demonstrated a consistent track record in manufacturing and exporting pharmaceutical formulations, with a total export value of $960,000 USD across 41 shipments from 2022 to 2026. The company's portfolio includes three products across two therapeutic categories, with a concentration in vitamins & supplements (78.1%) and cardiovascular products (21.9%). The top three products—Iron, Magnesium, and Propranolol—account for 100% of the company's export value, indicating a focused product strategy. The company's adherence to cGMP guidelines and commitment to quality manufacturing further enhance its reliability as a supplier.

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

• FDA Approval: Confirm that the company's products are approved by the U.S. Food and Drug Administration (FDA) by checking the FDA's official database.

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

• EU GMP Certification: Ensure that the facility meets European Union GMP standards by reviewing the European Directorate for the Quality of Medicines & HealthCare (EDQM) database.

• ISO Certification: Check for International Organization for Standardization (ISO) certifications related to quality management systems by reviewing the ISO's official listings.

Importers should undertake the following steps to verify the credibility and reliability of Kausikh Therapeutics:

• Review Regulatory Approvals: Confirm that the company's products have the necessary approvals from relevant regulatory authorities, such as the FDA, WHO, and EU.

• Assess Manufacturing Facilities: Evaluate the company's manufacturing facilities for compliance with