Dheer Health Care Private Limited

Dheer Health Care Private Limited is a privately held pharmaceutical company established on September 15, 2015, in Mumbai, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U33111MH2015PTC268436. Its authorized share capital is ₹1,000,000, with a paid-up capital of ₹100,000. The registered office is located at Office No. 904, 905 & 906, 9th Floor, Sunshine Tower, Senapati Bapat Marg, Dadar-West, Mumbai, Maharashtra, 400013.

Dheer Health Care specializes in the export of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company's product portfolio is concentrated, with its top five products accounting for 100% of its export value. In the fiscal year 2023, the company experienced a 9.45% decrease in revenue and a 14.11% decline in profit, while its net worth increased by 28.38%.

Specific details regarding Dheer Health Care's manufacturing facilities are not publicly disclosed. The company operates as an exporter and trader of pharmaceutical products, suggesting that its manufacturing processes may be outsourced to third-party contract manufacturers. This approach is common in the pharmaceutical industry, allowing companies to focus on distribution and market expansion while leveraging the manufacturing capabilities of specialized facilities.

The company's leadership comprises two directors:

• Kamlesh Ghisulal Jain: Director since September 15, 2015.

• Atish Ghisulal Jain: Director since September 15, 2015.

Both directors have been associated with the company since its inception, indicating a stable leadership structure. Their roles encompass strategic decision-making and overseeing the company's operations, particularly in the export and distribution of pharmaceutical products.

Dheer Health Care's export data indicates a focus on markets within the gastrointestinal and advanced oncology therapeutic categories. However, specific information regarding regulatory filings, approvals, and market access status in the United States, European Union, United Kingdom, Australia, and Japan is not publicly available. This lack of transparency may be due to the company's reliance on third-party manufacturers and distributors, which can complicate the disclosure of regulatory compliance details.

Dheer Health Care's export activities are not detailed in terms of specific emerging markets such as Africa, Latin America, and Southeast Asia. The company's focus on gastrointestinal and oncology products suggests potential interest in regions with a high prevalence of these conditions. However, without explicit information on WHO prequalification or other certifications, it is challenging to assess the company's penetration and market access in these regions.

The company's export portfolio is highly concentrated, with its top five products accounting for 100% of its export value. This indicates a focused geographic strategy, potentially targeting markets with high demand for these specific therapeutic categories. While this approach can lead to strong market positions in selected regions, it also exposes the company to risks associated with market fluctuations and regulatory changes in these areas.

Specific information regarding Dheer Health Care's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history is not publicly available. The company's reliance on third-party manufacturers may contribute to the lack of transparency in this area. Without direct FDA approvals, the company may face challenges in entering the U.S. market, as FDA approval is typically required for the sale of pharmaceutical products in the United States.

There is no publicly available information indicating that Dheer Health Care holds WHO prequalification or EU Good Manufacturing Practice (GMP) certificates. These certifications are crucial for accessing international markets, particularly in regions with stringent regulatory standards. The absence of such certifications may limit the company's ability to expand its presence in these markets.

Dheer Health Care is registered with the Ministry of Corporate Affairs (MCA) under the Corporate Identification Number (CIN) U33111MH2015PTC268436. The company's authorized share capital is ₹1,000,000, with a paid-up capital of ₹100,000. Specific details regarding manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), state drug controller approvals, and export No Objection Certificates (NOCs) are not publicly disclosed. The company's reliance on third-party manufacturers may contribute to the lack of transparency in this area.

There is no publicly available information regarding Form 483 observations, warning letters, or import alerts associated with Dheer Health Care. The company's reliance on third-party manufacturers may result in limited visibility into its regulatory compliance history. Without direct regulatory approvals, the company may face challenges in entering certain markets, as regulatory compliance is a critical factor for market access.

Dheer Health Care operates in the pharmaceutical export sector, focusing on gastrointestinal and oncology products. The company's top competitors in these therapeutic categories include established pharmaceutical exporters with a global presence. However, without specific market share data, it is challenging to provide a detailed head-to-head analysis. The company's reliance on third-party manufacturers may also impact its competitiveness, as it may face challenges in ensuring consistent product quality and meeting regulatory standards.

Dheer Health Care's key differentiators include its focus on specific therapeutic categories, such as gastrointestinal and oncology products, and its extensive distribution network. The company's commitment to quality management and timely deliveries contributes to customer satisfaction. However, the lack of direct manufacturing capabilities and regulatory certifications may limit its ability to differentiate itself in certain markets.

Dheer Health Care's current strategic direction appears to be focused on exporting a concentrated portfolio of gastrointestinal and oncology products. The company's reliance on third-party manufacturers allows it to offer a wide range of products without the need for in-house manufacturing facilities. However, the absence of direct regulatory approvals and certifications may pose challenges to its future growth and market expansion. To enhance its strategic position, the company may consider obtaining necessary regulatory approvals and certifications to access a broader range of markets.

Dheer Health Care's track record as an exporter is characterized by a focused product portfolio and a commitment to quality management. The company's reliance on third-party manufacturers necessitates a thorough assessment of these suppliers to ensure consistent product quality and compliance with regulatory standards. Indicators of reliability include the suppliers' certifications, inspection histories, and adherence to international quality standards.

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

• FDA Approval: Confirm that the product is approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. Verification can be done through the FDA's official website or by contacting the manufacturer directly.

• WHO-GMP Certification: Ensure that the manufacturing facility holds World Health Organization Good Manufacturing Practice (WHO-GMP) certification. This can be verified by checking the WHO's official list of prequalified manufacturers.

• EU GMP Certification: Confirm that the manufacturing facility complies with European Union Good Manufacturing Practice (EU GMP) standards. Verification can be done through the European Medicines Agency (EMA) or the national competent authorities of EU member states.

• ISO Certification: Check for International Organization for Standardization (ISO) certifications related to quality management systems. These can be verified through the International Organization for Standardization's official website.

When considering a partnership with Dheer Health Care, importers should undertake the following due diligence steps:

• Verify Regulatory Approvals: Ensure that the products have the necessary regulatory approvals for the target market.

• Assess Supplier Reliability: Evaluate the reliability of third-party manufacturers by reviewing their certifications, inspection histories, and compliance with international quality standards.

• Review Financial Stability: Analyze the company's financial statements to assess its financial health and ability to fulfill orders.

• Check References: Obtain references from other clients or partners to gauge the company's reputation and reliability.

• Inspect Product Quality: Conduct quality inspections or request samples to verify product quality before placing large orders.

Red flags to watch for include a lack of transparency in regulatory compliance, inconsistent product quality, and financial instability. Recommended pre-order checks involve verifying certifications, assessing supplier reliability, and conducting quality inspections.