Al-royal Pharmaceutical Private Limited

Al-Royal Pharmaceutical Private Limited is an Indian pharmaceutical exporter established on August 1, 2017, in New Delhi, Delhi, India. The company is registered under the Corporate Identification Number (CIN) U24290DL2017PTC321538. It operates as a private limited company, classified as a non-government entity, and is unlisted on stock exchanges. The authorized and paid-up capital of the company is ₹100,000.

The registered office is located at RZT-118, First Floor, Uttam Nagar Near Chawla Sweet, New Delhi, Delhi, 110059, India. The company specializes in the manufacturing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections, primarily focusing on the advanced oncology therapeutic category.

Specific details regarding Al-Royal Pharmaceutical Private Limited's manufacturing facilities, including locations, capacities, and specializations, are not publicly disclosed. The company's operations are registered under the NIC code 2429, which pertains to the manufacture of other chemical products not elsewhere classified. This classification suggests that the company may engage in the production of various pharmaceutical products, potentially including oncology medications.

The company's leadership comprises two directors:

• Ramjas Jain: Appointed on August 1, 2017.
• Davinder Jain Kumar: Appointed on June 13, 2019.

The roles of Chief Executive Officer (CEO) and Chief Financial Officer (CFO) are not specified in the available public records.

Al-Royal Pharmaceutical 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 activities, as per TransData Nexus proprietary trade data, indicate a total export value of $71,000 USD across 24 shipments, with products primarily in the advanced oncology therapeutic category. However, specific regulatory filings, approvals, and market access statuses in these regions are not publicly disclosed.

The company's penetration into emerging markets in Africa, Latin America, and Southeast Asia is not detailed in the available public records. The absence of specific information regarding WHO prequalification or other certifications that would enable access to these markets suggests that Al-Royal Pharmaceutical Private Limited may not currently have a significant presence in these regions.

Al-Royal Pharmaceutical Private Limited's export activities, as indicated by TransData Nexus proprietary trade data, are concentrated in the advanced oncology therapeutic category, with a portfolio concentration of 100% in this area. The company's geographic strategy appears to be focused on markets that require specialized oncology medications. However, the lack of publicly available information on specific market diversification efforts or expansion plans suggests a potential concentration risk.

Specific details regarding Al-Royal Pharmaceutical Private Limited's FDA 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 indicates shipments of finished pharmaceutical formulations, including oncology drugs, but does not provide information on FDA approvals or compliance status.

There is no publicly available information confirming whether Al-Royal Pharmaceutical Private Limited holds WHO prequalification or EU Good Manufacturing Practice (GMP) certificates. These certifications are crucial for market access in various international regions, and the absence of such information may impact the company's ability to enter certain markets.

Al-Royal Pharmaceutical Private Limited is registered with the Central Drugs Standard Control Organisation (CDSCO) under the Corporate Identification Number (CIN) U24290DL2017PTC321538. Specific details regarding CDSCO manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not publicly disclosed. The company's registered office address is RZT-118, First Floor, Uttam Nagar Near Chawla Sweet, New Delhi, Delhi, 110059, India.

There is no publicly available information regarding any Form 483 observations, warning letters, or import alerts issued to Al-Royal Pharmaceutical Private Limited. The company's compliance status appears to be active, but specific details on regulatory actions are not disclosed.

Al-Royal Pharmaceutical Private Limited operates in the advanced oncology therapeutic category, exporting finished pharmaceutical formulations such as Dacarbazine, Lenvatinib, and Mercaptopurine. The company's total export value is $71,000 USD across 24 shipments, with a portfolio concentration of 100% in this category. While specific market share data and a comprehensive list of competitors are not available, the company's focus on specialized oncology medications suggests competition with other pharmaceutical exporters in this niche market.

Al-Royal Pharmaceutical Private Limited's key differentiator lies in its specialized focus on advanced oncology medications. The company's portfolio includes products such as Dacarbazine, Lenvatinib, and Mercaptopurine, indicating expertise in this therapeutic area. However, the lack of publicly available information on certifications like WHO prequalification or EU GMP may limit its competitive advantage in certain international markets.

Al-Royal Pharmaceutical Private Limited's current strategic direction appears to be centered on the export of specialized oncology medications. The company's portfolio concentration in this therapeutic area suggests a focused approach. However, the absence of publicly available information on diversification into generics, specialty drugs, biosimilars, or Contract Development and Manufacturing Organization (CDMO) services indicates that the company may not currently be pursuing these avenues. Future strategic directions may involve obtaining international certifications to enhance market access and exploring diversification opportunities to mitigate concentration risks.

Al-Royal Pharmaceutical Private Limited's track record in terms of export volume and consistency is not extensively documented in public records. The company's export data indicates shipments of finished pharmaceutical formulations, primarily in the advanced oncology category, but does not provide detailed insights into reliability indicators or consistency over time. The lack of publicly available information on certifications and regulatory approvals may impact the company's reliability as a supplier in certain markets.

Importers should verify the following certifications when considering Al-Royal Pharmaceutical Private Limited as a supplier:

• FDA Facility Registration: To confirm compliance with U.S. regulations.
• WHO Prequalification: To ensure acceptance in international markets.
• EU GMP Certificate: To meet European Union standards.
• ISO Certifications: To assess quality management systems.

Verification can be conducted through official regulatory bodies' websites or by requesting documentation directly from the company.

When conducting due diligence on Al-Royal Pharmaceutical Private Limited, consider the following steps:

• Verify Regulatory Certifications: Confirm FDA registration, WHO prequalification, EU GMP certification, and ISO certifications.
• Assess Financial Health: Review financial statements and balance sheets for profitability and stability.
• Evaluate Compliance History: Investigate any past regulatory actions or compliance issues.
• Inspect Manufacturing Facilities: If possible, conduct site visits to assess manufacturing practices and quality control measures.

Red flags to watch for include a lack of verifiable certifications, inconsistent financial performance, and unresolved regulatory issues.