Amol Pharmaceuticals Private Limited

Amol Pharmaceuticals Private Limited, established on February 12, 1996, is a privately held pharmaceutical company headquartered in Jaipur, Rajasthan, India. The company is registered under the Corporate Identification Number (CIN) U24230RJ1996PTC097657. It operates as a non-government entity, focusing on the manufacturing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The authorized capital stands at ₹7.50 million, with a paid-up capital of ₹6.65 million. As of April 2024, Amol Pharmaceuticals employs approximately 316 professionals. The company's registered office is located at E-1, 362-363-364-365, Sitapura Industrial Area, Sanganer, Jaipur, Rajasthan 302022.

Amol Pharmaceuticals operates a state-of-the-art manufacturing facility situated in the Sitapura Industrial Area of Jaipur, Rajasthan. This plant specializes in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The facility is equipped with advanced laboratories and novel technologies, ensuring high-quality standards in its manufacturing processes.

The leadership team at Amol Pharmaceuticals comprises:

• Sandeep Sapra: Managing Director, appointed on March 1, 1996.

• Ashok Luhadia: Director, appointed on February 12, 1996.

• Amol Luhadia: Director, appointed on August 23, 2001.

These individuals have been instrumental in steering the company's strategic direction and growth.

Amol Pharmaceuticals has made significant strides in expanding its presence in regulated markets:

• United States: The company has FDA registrations for its products, indicating compliance with U.S. regulatory standards. (fda.report)

• European Union: While specific EU regulatory approvals are not detailed, the company's adherence to international quality standards suggests potential market access.

• United Kingdom: No specific information on UK market access is available.

• Australia: The manufacturing plant has received approval from the Therapeutic Goods Administration (TGA), facilitating market entry.

• Japan: No specific information on Japanese market access is available.

Amol Pharmaceuticals has been proactive in penetrating emerging markets:

• Africa: The company has received approvals from the South African Health Products Regulatory Authority (SAHPRA), enabling access to the South African market.

• Latin America: Approvals from the Brazilian Health Regulatory Agency (ANVISA) have been obtained, facilitating entry into the Brazilian market.

• Southeast Asia: Specific information on market penetration in Southeast Asia is not detailed.

The company's adherence to international quality standards, as evidenced by these approvals, positions it favorably in these regions.

Amol Pharmaceuticals demonstrates a diversified geographic strategy by establishing a strong presence in both regulated and emerging markets. The company's approvals from regulatory bodies in the U.S., Australia, South Africa, and Brazil indicate a balanced approach to market expansion. This diversification mitigates concentration risk and aligns with a strategic direction focused on global market access.

Amol Pharmaceuticals has achieved FDA registrations for its products, reflecting compliance with U.S. regulatory standards. Specific details regarding approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly disclosed. The FDA registration underscores the company's commitment to maintaining high-quality manufacturing practices. (fda.report)

While specific certifications such as WHO prequalification and EU Good Manufacturing Practice (GMP) certificates are not detailed, Amol Pharmaceuticals' adherence to international quality standards suggests potential compliance with these certifications. The company's manufacturing facility is equipped with advanced laboratories and novel technologies, indicating a commitment to maintaining high-quality standards.

Amol Pharmaceuticals holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. Specific details regarding state drug controller approvals and export No Objection Certificates (NOCs) are not publicly disclosed. The company's compliance with CDSCO regulations underscores its commitment to maintaining high-quality manufacturing practices.

No specific information regarding Form 483 observations, warning letters, or import alerts is available. The absence of such information suggests that Amol Pharmaceuticals maintains a clean regulatory record.

Amol Pharmaceuticals operates in a competitive landscape with several key players in the pharmaceutical manufacturing sector. While specific competitors are not identified, the company's focus on high-quality finished pharmaceutical formulations positions it favorably in the market. The company's approvals from regulatory bodies in the U.S., Australia, South Africa, and Brazil enhance its competitive edge.

Amol Pharmaceuticals' key differentiators include:

• Regulatory Approvals: The company has obtained approvals from multiple international regulatory bodies, including the FDA, TGA, SAHPRA, and ANVISA, facilitating market access in various regions.

• Manufacturing Capabilities: Equipped with advanced laboratories and novel technologies, the company's manufacturing facility ensures high-quality standards in its products.

• Product Portfolio: The company's focus on finished pharmaceutical formulations, including tablets, capsules, syrups, and injections, caters to a broad spectrum of therapeutic needs.

Amol Pharmaceuticals' current strategic direction emphasizes global market expansion through obtaining regulatory approvals in key markets. The company's future outlook appears focused on leveraging its manufacturing capabilities and regulatory credentials to strengthen its position in both existing and new markets.

Amol Pharmaceuticals demonstrates a strong track record in manufacturing high-quality pharmaceutical products. The company's export volume and consistency are evidenced by its approvals from multiple international regulatory bodies, including the FDA, TGA, SAHPRA, and ANVISA. These approvals indicate the company's reliability and adherence to international quality standards.

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

• FDA Registration: Confirm the company's FDA registration status to ensure compliance with U.S. regulatory standards. (fda.report)

• WHO-GMP Certification: Verify the company's adherence to World Health Organization Good Manufacturing Practice standards.

• EU GMP Certification: Ensure the company holds European Union Good Manufacturing Practice certification.

• ISO Certification: Check for ISO certifications related to quality management systems.

Importers should undertake the following verification steps:

• Regulatory Compliance: Confirm the company's certifications and approvals from relevant regulatory bodies.

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

• Quality Assurance: Evaluate the company's quality control processes and manufacturing facilities.

• References: Seek references from existing clients to gauge reliability and performance.

Red flags to watch for include discrepancies in regulatory certifications, financial irregularities, and unresolved quality issues. Recommended pre-order checks involve obtaining product samples, conducting quality assessments, and ensuring compliance with import regulations.