Shree SSD Pharma Private Limited

Shree SSD Pharma Private Limited, established on August 6, 2012, is a private limited company headquartered in Nagpur, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U74120MH2012PTC234219. Its authorized and paid-up capital stands at ₹500,000 each. The registered office is located at 1st Floor, Shree SSD Heights, House No. 16, Besides Rajwada Palace, Ganjipeth, Nagpur, Maharashtra, 440002.

The company operates as a trader, wholesaler, and distributor in the pharmaceutical sector, focusing on finished pharmaceutical formulations such as tablets, capsules, syrups, and injections. As of the latest available data, Shree SSD Pharma employs up to 10 people and has an annual turnover ranging between ₹25 crore and ₹100 crore.

Shree SSD Pharma Private Limited does not own manufacturing facilities; instead, it operates as a trader, wholesaler, and distributor of pharmaceutical products. The company sources its products from various manufacturers to cater to its export and domestic distribution needs. Specific details regarding the manufacturing capacities and specializations of its suppliers are not publicly disclosed.

The leadership team of Shree SSD Pharma Private Limited comprises four directors:

• Shrichand Hundomal Daswani
• Manish Shrichand Daswani
• Jaiprakash Nandlal Tekchandani
• Jagdish Shrichand Daswani

These directors have been associated with the company since its inception on August 6, 2012.

Shree SSD Pharma Private Limited's export data indicates a focus on advanced diabetes medications, including Canagliflozin, Empagliflozin, Linagliptin, and Saxagliptin. However, specific regulatory approvals or market access statuses in the United States, European Union, United Kingdom, Australia, and Japan are not publicly available. The company's export activities primarily target markets where these products are in demand, but detailed regulatory information is not disclosed.

Shree SSD Pharma Private Limited's export data does not provide specific information regarding its presence in African, Latin American, or Southeast Asian markets. The company's focus appears to be on regions with established demand for its product portfolio. Without explicit data on WHO prequalification or other certifications, it is challenging to assess the company's penetration in these emerging markets.

The company's export data reveals a concentrated portfolio, with the top five products accounting for 100% of its exports. This indicates a high level of concentration risk. Diversification into additional therapeutic categories or geographic regions could mitigate this risk and enhance the company's strategic position.

Specific information regarding Shree SSD Pharma Private Limited's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, or inspection history is not publicly available. As the company operates as a trader and distributor, it is likely that its manufacturing partners hold the necessary FDA approvals for the products it exports.

There is no publicly available information confirming whether Shree SSD Pharma Private Limited or its manufacturing partners hold WHO prequalification or EU Good Manufacturing Practice (GMP) certificates. Such certifications are crucial for market access in various regions, and the absence of this information may impact the company's ability to enter certain markets.

Shree SSD Pharma Private Limited is registered with the Directorate General of Foreign Trade (DGFT) under the Import Export Code (IEC) 5012002652, indicating its authorization to export pharmaceutical products. Specific details regarding manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) or state drug controller approvals are not publicly disclosed.

There is no publicly available information regarding any Form 483 observations, warning letters, or import alerts associated with Shree SSD Pharma Private Limited. The company's compliance status appears to be active and compliant, with no significant regulatory actions reported.

Shree SSD Pharma Private Limited operates in a competitive pharmaceutical export market, focusing on advanced diabetes medications. While specific competitors are not identified, the company's concentrated product portfolio may limit its market share in comparison to competitors with diversified offerings. Expanding its product range and geographic reach could enhance its competitive position.

The company's specialization in advanced diabetes medications, including Canagliflozin, Empagliflozin, Linagliptin, and Saxagliptin, positions it as a focused player in this therapeutic area. However, the lack of diversification in its product portfolio may limit its appeal to a broader customer base.

Shree SSD Pharma Private Limited's current strategic direction appears to be focused on exporting a limited range of advanced diabetes medications. To strengthen its market position, the company could consider diversifying its product portfolio, obtaining relevant certifications, and expanding into new geographic markets.

As a trader and distributor, Shree SSD Pharma Private Limited relies on its manufacturing partners for product quality and regulatory compliance. The company's export data indicates a focus on high-demand products, suggesting a consistent supply chain. However, the lack of publicly available information on supplier certifications and compliance histories makes it challenging to fully assess the reliability of its suppliers.

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

• FDA Approval: Confirm that the manufacturing facility holds FDA approval for the specific products. Verification can be done through the FDA's official website.

• WHO-GMP: Ensure that the manufacturing facility complies with WHO Good Manufacturing Practices. Verification can be done through the WHO's official website.

• EU GMP: Check that the manufacturing facility adheres to EU Good Manufacturing Practices. Verification can be done through the European Medicines Agency's official website.

• ISO Certification: Verify that the manufacturing facility holds relevant ISO certifications for quality management systems. Verification can be done through the International Organization for Standardization's official website.

Importers should undertake the following steps to ensure product quality and regulatory compliance:

• Supplier Verification: Confirm the manufacturing facility's certifications and compliance with relevant regulatory standards.

• Product Quality Assessment: Request samples and conduct quality testing to ensure product standards are met.

• Regulatory Compliance Check: Ensure that the products are approved for sale in the target market and that all necessary documentation is in place.

• Supply Chain Evaluation: Assess the reliability and consistency of the supplier's delivery schedules and logistics capabilities.

• Financial Stability Review: Evaluate the financial health of the supplier to ensure long-term viability.

By following this checklist, importers can mitigate risks and establish a reliable supply chain with Shree SSD Pharma Private Limited.