Synmedic Laboratories

Synmedic Laboratories Private Limited, established on September 18, 2009, is a privately held pharmaceutical company headquartered in New Delhi, India. The company is registered under the Corporate Identification Number (CIN) U24232DL2009PTC194500. Synmedic specializes in the manufacture and export of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. In 2013, Synmedic became part of the Dhanuka Group of Companies, a diversified conglomerate, which has provided additional resources and professional management to enhance its operations.

The company's authorized capital is ₹0.10 million, with a paid-up capital of ₹0.10 million. As of the latest available data, Synmedic Laboratories employs between 51 to 200 individuals. The company's registered office is located at 82, Abhinash Mansion, 1st Floor, Joshi Road, Karol Bagh, New Delhi, Delhi 110005, India.

Synmedic Laboratories operates a state-of-the-art manufacturing facility in Faridabad, Haryana, India. The plant is equipped with sophisticated instruments, including U.V. Spectrophotometer, H.P.L.C, G.C., and F.T.I.R. Spectrophotometer, to ensure high-quality production standards. The facility adheres to current Good Manufacturing Practices (cGMP) norms, with continuous efforts to improve manufacturing systems and Standard Operating Procedures for better Quality Assurance.

The leadership team at Synmedic Laboratories includes Directors Harsh Dhanuka and Manish Dhanuka, who have been associated with the company since 2015. The company's management comprises qualified professionals in manufacturing, quality control, quality assurance, marketing, research, and development, ensuring a comprehensive approach to pharmaceutical production and export.

Synmedic Laboratories has established a presence in various regulated markets, including Southeast Asia, Africa, the Commonwealth of Independent States (CIS), and South America. The company's manufacturing facility has been audited and approved by regulatory authorities from these regions, facilitating market access. Synmedic's regulatory affairs team has obtained over a hundred product registrations globally, demonstrating its commitment to meeting international standards.

Synmedic Laboratories has expanded its reach into emerging markets across Africa, Latin America, and Southeast Asia. The company's adherence to international regulatory standards, including obtaining approvals from various countries, has enabled it to penetrate these markets effectively. Synmedic's commitment to quality and regulatory compliance has facilitated its growth in these regions.

Synmedic Laboratories' export portfolio is concentrated in two therapeutic categories: Gastrointestinal (80.1%) and CNS & Psychiatric (19.9%). The company's top five products—Sulfasalazine and Alprazolam—account for 100% of its export value, indicating a high level of portfolio concentration. This focus on a limited number of products and therapeutic areas may expose the company to risks associated with market fluctuations and regulatory changes in these segments.

Synmedic Laboratories has not publicly disclosed specific details regarding its FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, or inspection history. The company's regulatory affairs team has obtained over a hundred product registrations globally, indicating a proactive approach to meeting international standards.

Synmedic Laboratories has not publicly disclosed specific details regarding its World Health Organization (WHO) prequalification status or European Union Good Manufacturing Practice (EU GMP) certifications. The company's manufacturing facility has been audited and approved by various regulatory authorities from Southeast Asia, Africa, the Commonwealth of Independent States (CIS), and South America, facilitating market access in these regions.

Synmedic Laboratories holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) in India. The company's manufacturing facility has been audited and approved by various regulatory authorities, indicating compliance with Indian regulatory standards. Synmedic's regulatory affairs team has obtained over a hundred product registrations globally, demonstrating its commitment to meeting international standards.

Synmedic Laboratories has not publicly disclosed any recent Form 483 observations, warning letters, or import alerts. The company's manufacturing facility has been audited and approved by various regulatory authorities from Southeast Asia, Africa, the Commonwealth of Independent States (CIS), and South America, facilitating market access in these regions.

Synmedic Laboratories operates in the pharmaceutical export market, focusing on finished pharmaceutical formulations in the gastrointestinal and CNS & psychiatric therapeutic categories. The company's top competitors in overlapping categories include established pharmaceutical exporters with diversified product portfolios and global market presence. Synmedic's portfolio concentration on a limited number of products and therapeutic areas may impact its competitive positioning in the broader market.

Synmedic Laboratories' key differentiators include its focus on quality manufacturing, adherence to international regulatory standards, and a specialized product portfolio in the gastrointestinal and CNS & psychiatric therapeutic categories. The company's manufacturing facility is equipped with advanced instruments and follows cGMP norms, ensuring high-quality production standards.

Synmedic Laboratories' current strategic direction focuses on the manufacture and export of finished pharmaceutical formulations, with a concentration on gastrointestinal and CNS & psychiatric therapeutic categories. The company's portfolio concentration on a limited number of products and therapeutic areas may expose it to risks associated with market fluctuations and regulatory changes in these segments. Future strategic initiatives may involve diversification of the product portfolio and expansion into additional therapeutic areas to mitigate concentration risks.

Synmedic Laboratories has a track record of obtaining over a hundred product registrations globally, indicating a proactive approach to meeting international standards. The company's manufacturing facility has been audited and approved by various regulatory authorities from Southeast Asia, Africa, the Commonwealth of Independent States (CIS), and South America, facilitating market access in these regions.

Importers should verify the following certifications when considering Synmedic Laboratories as a supplier:

• FDA Facility Registration: Confirm the facility's registration status with the U.S. Food and Drug Administration (FDA).

• WHO-GMP Certification: Verify the World Health Organization's Good Manufacturing Practice certification.

• EU GMP Certification: Confirm compliance with European Union Good Manufacturing Practice standards.

• ISO Certification: Ensure the company holds relevant International Organization for Standardization certifications.

To verify these certifications, contact Synmedic Laboratories directly or consult the respective regulatory bodies' official websites.

When conducting due diligence on Synmedic Laboratories, consider the following steps:

• Verify Regulatory Approvals: Confirm the company's compliance with relevant regulatory bodies, including the FDA, WHO, EU GMP, and ISO standards.

• Assess Financial Stability: Review the company's financial statements and credit history to evaluate its financial health.

• Evaluate Manufacturing Capabilities: Inspect the manufacturing facility to ensure it meets quality and regulatory standards.

• Review Product Portfolio: Analyze the product portfolio to assess diversification and market demand.

• Check References: Obtain feedback from existing clients and partners regarding the company's reliability and performance.

Red flags to watch for include a lack of transparency in regulatory approvals, financial inconsistencies, and limited product diversification. Recommended pre-order checks involve verifying certifications, assessing the company's reputation in the market, and ensuring compliance with contractual terms.