Vivalia Remedies Private Limited

Vivalia Remedies Private Limited is an Indian pharmaceutical exporter established on September 2, 2011, in New Delhi, Delhi, India. The company is registered under the Corporate Identification Number (CIN) U74900DL2011PTC224457. It operates as a private limited company, unlisted on stock exchanges, with an authorized and paid-up capital of ₹100,000.

The registered office is located at L 69/A, Third Floor, New Delhi, Delhi, 110017. The company's primary business activity is drug formulation and development, focusing on the export of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections.

Financially, Vivalia Remedies has experienced fluctuations in recent years. In the fiscal year ending March 31, 2024, the company reported a 50.76% decrease in total revenue compared to the previous year. Despite this decline, the net worth increased by 19.73%, indicating a strengthening financial position.

Specific details regarding Vivalia Remedies Private Limited's manufacturing facilities, including locations, capacities, and specializations, are not publicly disclosed. The company focuses on the export of finished pharmaceutical formulations, suggesting that its manufacturing operations are aligned with this product line. However, without explicit information, a comprehensive assessment of their manufacturing capabilities cannot be provided.

Vivalia Remedies Private Limited is led by two directors:

• Vaibhav Ahluwalia Kumar: Appointed on September 2, 2011, he serves as a director of the company.

• Praveenkumari Ahluwalia: Also appointed on September 2, 2011, she holds the position of director.

The company's leadership structure is relatively simple, with these two individuals at the helm. No additional key executives or management personnel are publicly listed, indicating a streamlined organizational hierarchy.

Vivalia Remedies Private Limited's presence in regulated markets such as the United States, European Union, United Kingdom, Australia, and Japan is not explicitly detailed in the available public records. The company's export data indicates a focus on oncology products, including Ifosfamide, Bleomycin, and Cyclophosphamide, which are critical in cancer treatment. However, without specific regulatory filings or approvals, it is challenging to ascertain the company's market access status in these regions.

Vivalia Remedies Private Limited's export data highlights a significant focus on oncology products, particularly Ifosfamide, Bleomycin, and Cyclophosphamide. While the company's export activities suggest a potential presence in emerging markets, specific information regarding its penetration in regions such as Africa, Latin America, and Southeast Asia is not publicly available. The company's emphasis on oncology products may align with the growing demand for cancer treatments in these regions. However, without explicit data, a detailed analysis of their market presence cannot be provided.

Vivalia Remedies Private Limited's export data reveals a concentrated portfolio, with its top three products—Ifosfamide, Bleomycin, and Cyclophosphamide—accounting for 100% of its export value. This indicates a high level of concentration risk, as the company's revenue is heavily dependent on a limited number of products. The strategic direction appears to be focused on oncology, particularly advanced oncology, as evidenced by the 78.8% share in this therapeutic category. Diversification into other therapeutic areas or product lines could mitigate potential risks associated with this concentration.

Specific details regarding Vivalia Remedies Private Limited's interactions with the U.S. Food and Drug Administration (FDA), including facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history, are not publicly available. The company's export data does not provide insights into its regulatory standing with the FDA. Without explicit information, a comprehensive assessment of the company's FDA status cannot be conducted.

Information regarding Vivalia Remedies Private Limited's compliance with World Health Organization (WHO) prequalification, European Union Good Manufacturing Practice (EU GMP) certificates, or European Directorate for the Quality of Medicines & HealthCare (EDQM) status is not publicly disclosed. The company's export data does not indicate adherence to these international quality standards. Without specific certifications or approvals, it is challenging to evaluate the company's compliance with WHO and EU GMP requirements.

Vivalia Remedies Private Limited's compliance with the Central Drugs Standard Control Organisation (CDSCO) and other Indian regulatory bodies, including manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs), is not detailed in the available public records. The company's export data does not provide insights into its regulatory standing within India. Without explicit information, a comprehensive assessment of the company's compliance with Indian regulatory requirements cannot be conducted.

There are no publicly available records indicating any recent regulatory actions against Vivalia Remedies Private Limited, such as Form 483 observations, warning letters, or import alerts. The company's export data does not suggest any compliance issues or regulatory challenges. However, the absence of such records does not guarantee that the company is free from regulatory scrutiny.

Vivalia Remedies Private Limited operates in the oncology pharmaceutical sector, focusing on products like Ifosfamide, Bleomycin, and Cyclophosphamide. The competitive landscape in this niche is characterized by several established global and regional players. While specific market share data is not available, the company's emphasis on advanced oncology products positions it in a competitive market segment. A detailed head-to-head analysis would require access to proprietary market intelligence and competitor data.

Vivalia Remedies Private Limited's key differentiators include its specialized focus on oncology products, particularly in the advanced oncology category, which constitutes 78.8% of its export value. The company's portfolio concentration on a select number of products may allow for specialized expertise and quality control. However, this focus also exposes the company to risks associated with market fluctuations and regulatory changes affecting these specific products.

Vivalia Remedies Private Limited's current strategic direction appears to be centered on the export of oncology products, with a strong emphasis on advanced oncology treatments. The company's concentrated product portfolio suggests a strategy focused on depth rather than breadth. Future outlooks would benefit from diversification into other therapeutic areas or product lines to mitigate risks associated with market concentration and to capitalize on emerging opportunities in the global pharmaceutical market.

Vivalia Remedies Private Limited's track record as a supplier is not extensively documented in the available public records. The company's export data indicates a focus on oncology products, with a total export value of $698,000 USD across 15 shipments. The portfolio concentration on a limited number of products may suggest a specialized and consistent supply capability. However, without detailed information on customer feedback, delivery performance, and quality metrics, a comprehensive assessment of the company's reliability as a supplier cannot be conducted.

Importers considering Vivalia Remedies Private Limited as a supplier 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. Verification can be done through the FDA's official website or by contacting the company directly.

• WHO-GMP Certification: Ensure that the manufacturing facilities comply with World Health Organization Good Manufacturing Practice standards. This can be verified by reviewing the company's certifications or by contacting the World Health Organization.

• EU GMP Certification: Check for compliance with European Union Good Manufacturing Practice standards. Verification can be done through the European Medicines Agency or by contacting the company directly.

• ISO Certification: Verify that the company holds relevant ISO certifications, such as ISO 9001 for quality management systems. This information can typically be found on the company's official website or by contacting them directly.

Importers should undertake the following steps to ensure a thorough evaluation of Vivalia Remedies Private Limited:

• Verify Regulatory Approvals: Confirm that the company's products are approved by relevant regulatory bodies in the target market.

• Assess Manufacturing Capabilities: Evaluate the company's manufacturing facilities for compliance with international quality standards.

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

• Check References and Reviews: Seek feedback from existing