Citro Pharma Private Limited

Citro Pharma Private Limited, incorporated on October 14, 2016, is a private pharmaceutical company based in Bangalore, Karnataka, India. The company is registered under the Corporate Identification Number (CIN) U24230KA2016PTC097166. Its authorized and paid-up capital stands at ₹100,000 each. The registered office is located at No. 2/A, 4th Main Shampura, K G Halli, Bangalore, Karnataka, 560045.

Citro Pharma specializes in the manufacturing and export of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company's export activities are primarily focused on biologics and immunotherapy products, with a notable presence in the advanced oncology therapeutic category. In the fiscal year 2022, Citro Pharma reported a total export value of $9,000 USD, encompassing seven shipments across two therapeutic categories. The top five exported products include Etanercept and Axitinib, with Etanercept accounting for $6,000 USD and Axitinib for $3,000 USD. The company's portfolio is highly concentrated, with the top five products comprising 100% of its export value.

Citro Pharma operates a state-of-the-art manufacturing facility spanning 7,000 square meters, equipped with modern equipment and adhering to current Good Manufacturing Practice (cGMP) standards. The facility is designed to produce both liquid and lyophilized products, including injectable formulations, oncology drugs, biosimilars, and vaccines. It features a fully automated system compliant with GAMP-4 guidelines, ensuring high-quality production processes. The manufacturing plant has been validated through successful inspections by regulatory bodies such as the UK MHRA, Australia TGA, PICS, MCC South Africa, and Canada Health, resulting in cGMP compliance and certifications.

The leadership team at Citro Pharma comprises directors Shaikh Mukhtar Ahmed, Mukhtar Ahmed, and Ashfaq Ahmed, who have been associated with the company since its inception on October 14, 2016. While specific roles such as CEO, Managing Director, and CFO are not explicitly detailed in the available sources, the directors play a pivotal role in steering the company's strategic direction and operations.

Citro Pharma's export activities are primarily focused on biologics and immunotherapy products, with a notable presence in the advanced oncology therapeutic category. In the fiscal year 2022, the company reported a total export value of $9,000 USD, encompassing seven shipments across two therapeutic categories. The top five exported products include Etanercept and Axitinib, with Etanercept accounting for $6,000 USD and Axitinib for $3,000 USD. The company's portfolio is highly concentrated, with the top five products comprising 100% of its export value.

Citro Pharma has established a significant presence in emerging markets, particularly in regions such as Southeast Asia, the Middle East, and Africa. The company's manufacturing facility in Southeast Asia and the Middle East spans 7,000 square meters and is designed to produce injectable formulations, oncology drugs, biosimilars, and vaccines. This strategic positioning enables Citro Pharma to cater to the healthcare needs of these regions effectively.

Citro Pharma's geographic strategy involves a focused approach on emerging markets, including Southeast Asia, the Middle East, and Africa. The establishment of a manufacturing facility in these regions allows the company to meet the growing demand for affordable and high-quality pharmaceutical products. This strategic positioning helps mitigate concentration risk by diversifying the company's market presence and aligning with global healthcare needs.

Specific details regarding Citro Pharma's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not available in the provided sources. The company's manufacturing facility has been validated through successful inspections by regulatory bodies such as the UK MHRA, Australia TGA, PICS, MCC South Africa, and Canada Health, resulting in cGMP compliance and certifications.

Citro Pharma's manufacturing facility has been validated through successful inspections by regulatory bodies such as the UK MHRA, Australia TGA, PICS, MCC South Africa, and Canada Health, resulting in cGMP compliance and certifications. However, specific details regarding WHO prequalification and EU GMP certificates are not available in the provided sources.

Specific details regarding Citro Pharma's CDSCO manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not available in the provided sources. The company's manufacturing facility has been validated through successful inspections by regulatory bodies such as the UK MHRA, Australia TGA, PICS, MCC South Africa, and Canada Health, resulting in cGMP compliance and certifications.

There are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Citro Pharma. The company's manufacturing facility has been validated through successful inspections by regulatory bodies such as the UK MHRA, Australia TGA, PICS, MCC South Africa, and Canada Health, resulting in cGMP compliance and certifications.

Citro Pharma operates in the competitive pharmaceutical industry, focusing on biologics, immunotherapy, and oncology products. While specific competitors in overlapping categories are not detailed in the provided sources, the company's emphasis on high-quality, affordable medicines positions it to compete effectively in both regulated and emerging markets. The establishment of manufacturing facilities in strategic locations enhances its ability to meet global healthcare needs and respond to market demands.

Citro Pharma's key differentiators include its state-of-the-art manufacturing facility adhering to cGMP standards, strategic geographic positioning in emerging markets, and a focused product portfolio in biologics, immunotherapy, and oncology. The company's commitment to quality and affordability enables it to meet the diverse healthcare needs of various regions effectively.

Citro Pharma's current strategic direction focuses on the manufacturing and export of biologics, immunotherapy, and oncology products, with a strong emphasis on emerging markets. The establishment of manufacturing facilities in Southeast Asia and the Middle East aligns with the company's goal to provide affordable and high-quality medicines globally. Future outlooks suggest continued expansion in these regions, leveraging strategic partnerships and adhering to international regulatory standards to enhance market presence.

Citro Pharma demonstrates a strong track record in pharmaceutical manufacturing, with a focus on biologics, immunotherapy, and oncology products. The company's manufacturing facility is equipped with modern equipment and adheres to cGMP standards, ensuring high-quality production processes. The facility has been validated through successful inspections by regulatory bodies such as the UK MHRA, Australia TGA, PICS, MCC South Africa, and Canada Health, resulting in cGMP compliance and certifications.

Importers should verify the following certifications when considering Citro Pharma as a supplier:

• FDA Facility Registration: Confirm the company's registration status with the U.S. Food and Drug Administration (FDA) to ensure compliance with U.S. regulations.

• WHO-GMP Certification: Verify the World Health Organization's Good Manufacturing Practice (WHO-GMP) certification to ensure adherence to international manufacturing standards.

• EU GMP Certification: Check for European Union Good Manufacturing Practice (EU GMP) certification to confirm compliance with European manufacturing standards.

• ISO Certification: Ensure the company holds relevant International Organization for Standardization (ISO) certifications, indicating adherence to international quality management standards.

To verify these certifications, importers can request copies of the certificates directly from Citro Pharma or consult the respective regulatory bodies' official websites for validation.

When conducting due diligence on Citro Pharma, consider the following steps:

• Verify Regulatory Certifications: Confirm the validity of FDA, WHO-GMP, EU GMP, and ISO certifications.

• Assess Manufacturing Capabilities: Evaluate the company's manufacturing facilities for compliance with international standards and capacity to meet order requirements.

• Review Financial Statements: Analyze the company's financial health by reviewing recent balance sheets and profit and loss statements.

• Check Export Records: Examine the company's export history to