Sparsh Bio-tech Private Limited

Sparsh Bio-Tech Private Limited, established on March 30, 2001, is a privately held pharmaceutical company headquartered in Jamnagar, Gujarat, India. The company specializes in the manufacturing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. Its Corporate Identification Number (CIN) is U24231GJ2001PTC039373. As of the latest available data, Sparsh Bio-Tech has an authorized capital of ₹5.00 crore and a paid-up capital of ₹3.35 crore. The company employs approximately 104 professionals. The registered office is located at Plot No.1, Survey No. 242/243/244, Village Lakhabavad, Post Khodiyar Colony, District Jamnagar, Gujarat, 361006.

Sparsh Bio-Tech operates a dedicated beta-lactam unit in Jamnagar, Gujarat, India. This facility is WHO-GMP certified and specializes in the production of finished pharmaceutical formulations, including tablets, capsules, and dry syrups. The plant is an export-oriented unit, supplying products to various countries such as Uganda, Rwanda, Kenya, Congo, Tanzania, Zambia, Guyana, Cambodia, Burundi, Ghana, and Madagascar.

The leadership team at Sparsh Bio-Tech includes:

• Ashok Juthalal Maru: Managing Director since March 30, 2001.

• Paras Juthalal Maru: Whole-Time Director since April 1, 2003.

• Sundeep Premchand Maru: Whole-Time Director since September 30, 2005.

• Rasik Hirji Haria: Director since November 3, 2001.

These individuals have been instrumental in steering the company's strategic direction and operational growth.

Sparsh Bio-Tech's export portfolio is concentrated in the antibiotic segment, with a total export value of $17.0 million USD across 392 shipments. The primary products exported are Ampicillin ($10.4 million, 7.3% market share) and Amoxicillin ($6.5 million, 1.1% market share), both of which are finished pharmaceutical formulations. The company's focus on these products indicates a strategic emphasis on the antibiotic therapeutic category. While specific regulatory approvals in the US, EU, UK, Australia, and Japan are not detailed in the available data, the company's export activities to various countries suggest compliance with international regulatory standards.

Sparsh Bio-Tech has established a presence in several emerging markets, including countries in Africa (Uganda, Rwanda, Kenya, Congo, Tanzania, Zambia, Ghana, Madagascar), Latin America (Guyana), and Southeast Asia (Cambodia, Burundi). The company's WHO-GMP certification for its manufacturing facility enhances its credibility and facilitates access to these markets. This certification is recognized by the World Health Organization and is a prerequisite for supplying pharmaceutical products to many countries.

Sparsh Bio-Tech's export strategy demonstrates a targeted approach, focusing on specific markets in Africa, Latin America, and Southeast Asia. This geographic concentration allows the company to tailor its marketing and distribution efforts effectively. However, the lack of diversification into other regions may expose the company to risks associated with over-reliance on a limited number of markets. Strategic expansion into additional regions could mitigate this risk and provide new growth opportunities.

The available data does not provide specific information regarding Sparsh Bio-Tech's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, or inspection history. This lack of information suggests that the company may not currently have FDA approvals for its products. For importers in the United States, it is crucial to verify the regulatory status of Sparsh Bio-Tech's products to ensure compliance with FDA requirements.

Sparsh Bio-Tech's manufacturing facility holds WHO-GMP certification, indicating adherence to international quality standards. However, there is no specific information available regarding EU GMP certification or EDQM status. Importers in the European Union should verify the company's compliance with EU GMP standards to ensure product quality and regulatory acceptance.

The available data does not detail Sparsh Bio-Tech's compliance with the Central Drugs Standard Control Organisation (CDSCO) regulations, state drug controller approvals, or export No Objection Certificates (NOCs). Importers should conduct due diligence to confirm the company's adherence to Indian regulatory requirements, which is essential for ensuring the legality and safety of the products.

There is no information available regarding any Form 483 observations, warning letters, or import alerts associated with Sparsh Bio-Tech. The absence of such records suggests that the company has maintained a clean regulatory history. Nonetheless, importers should perform thorough due diligence to confirm the company's compliance with all applicable regulations.

Sparsh Bio-Tech operates in the competitive antibiotic segment, with its top products being Ampicillin and Amoxicillin. The company's market share in these products is 7.3% and 1.1%, respectively. While specific competitors are not identified in the available data, the antibiotic market is typically characterized by numerous players, including both large multinational corporations and regional manufacturers. Sparsh Bio-Tech's focus on finished formulations and export-oriented strategy positions it to compete effectively in these markets.

Sparsh Bio-Tech's key differentiators include its WHO-GMP certified manufacturing facility, which ensures adherence to international quality standards, and its specialization in beta-lactam antibiotics. The company's export-oriented approach and focus on finished pharmaceutical formulations allow it to cater to a diverse clientele in emerging markets. These strengths contribute to its competitive advantage in the pharmaceutical export sector.

Sparsh Bio-Tech's current strategic direction centers on the production and export of finished pharmaceutical formulations, particularly beta-lactam antibiotics. The company's WHO-GMP certification and export activities indicate a commitment to quality and international market expansion. Future strategic initiatives could involve diversifying its product portfolio, expanding into new geographic regions, and obtaining additional regulatory approvals to enhance its global presence and competitiveness.

Sparsh Bio-Tech has demonstrated a consistent track record in exporting pharmaceutical products, with a total export value of $17.0 million USD across 392 shipments. The company's focus on finished pharmaceutical formulations and its WHO-GMP certified manufacturing facility underscore its commitment to quality and reliability. Importers should assess the company's compliance with relevant regulatory standards and verify the quality of its products to ensure a reliable supply chain.

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

• WHO-GMP Certification: Confirms adherence to international manufacturing standards.

• EU GMP Certification: Ensures compliance with European Union manufacturing standards.

• FDA Approval: Validates that products meet U.S. Food and Drug Administration requirements.

• ISO Certification: Indicates adherence to international quality management standards.

To verify these certifications, importers should request copies of the certificates from Sparsh Bio-Tech and cross-reference them with the issuing authorities' databases.

Importers should undertake the following steps to ensure a thorough evaluation of Sparsh Bio-Tech:

• Verify Regulatory Compliance: Confirm the company's adherence to relevant regulatory standards, including WHO-GMP, EU GMP, FDA, and ISO certifications.

• Assess Product Quality: Request product samples and conduct quality testing to ensure they meet required standards.

• Evaluate Financial Stability: Review the company's financial statements to assess its economic health and reliability as a supplier.

• Check References: Contact existing clients and partners to gather feedback on the company's performance and reliability.

• Inspect Manufacturing Facility: If possible, visit the manufacturing site to assess operational capabilities and quality control measures.

Red flags to watch for include discrepancies in certification documents, negative feedback from references, and signs of financial instability. Conducting comprehensive due diligence will help mitigate risks and ensure a successful partnership.