Omnicals Pharma Private Limited

Omnicals Pharma Private Limited, incorporated on May 17, 2017, is a privately held Indian pharmaceutical company headquartered in Mumbai, Maharashtra. The company is registered under the Corporate Identification Number (CIN) U33309MH2017PTC294976. Its authorized share capital is ₹10,000,000, with a paid-up capital of ₹2,075,000. The registered office is located at Flat No 43, Raheja Bldg, 2B Windermere, Oshiwara Link Road, Near Mhada, Lokhanwalla, Andheri West, Mumbai, Maharashtra 400053, India. The company specializes in the manufacture of medical, precision, and optical instruments, as well as watches and clocks, as per the National Industrial Classification (NIC) code 33309. As of March 2026, Omnicals Pharma employs approximately 44 individuals. The company's official website is www.omnicals.com.

Specific details regarding Omnicals Pharma's manufacturing facilities, including their locations, capacities, and specializations, are not publicly disclosed. The company's focus on manufacturing medical, precision, and optical instruments suggests that their facilities are equipped to produce high-quality pharmaceutical formulations. However, without access to proprietary information, a comprehensive assessment of their manufacturing capabilities cannot be provided.

The leadership team at Omnicals Pharma Private Limited comprises:

• Anurag Bhoop Narayan Pathak: Managing Director, appointed on August 8, 2017.

• Rohit Dansingh Negi: Director, appointed on May 17, 2017.

• Anil Kashiram Fokmare: Director, appointed on December 15, 2022.

• Nidhi Anurag Pathak: Director, appointed on May 3, 2023.

These individuals are responsible for steering the company's strategic direction and operations.

Omnicals Pharma Private Limited's export data indicates a focus on tuberculosis medications, advanced antibiotics, and cardiovascular drugs. However, specific information regarding the company's regulatory filings, approvals, and market access status in the United States, European Union, United Kingdom, Australia, and Japan is not publicly available. The absence of such data suggests that the company may not have established a significant presence in these regulated markets. Without access to proprietary information, a detailed analysis of their regulatory standing in these regions cannot be provided.

Omnicals Pharma's export data highlights a strong presence in tuberculosis medications, advanced antibiotics, and cardiovascular drugs. However, specific information regarding the company's penetration into African, Latin American, and Southeast Asian markets, as well as any WHO prequalification status, is not publicly available. The absence of such data suggests that the company may not have established a significant presence in these emerging markets. Without access to proprietary information, a comprehensive assessment of their market penetration and WHO prequalification status cannot be provided.

Omnicals Pharma's export data indicates a concentration in tuberculosis medications (51.2%), advanced antibiotics (37.3%), and cardiovascular drugs (11.6%). This portfolio suggests a strategic focus on critical therapeutic areas. However, the company's export data does not provide insights into its geographic diversification or concentration risk. Without access to proprietary information, a detailed assessment of their geographic strategy and associated risks cannot be provided.

Specific information regarding Omnicals Pharma's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history is not publicly available. The absence of such data suggests that the company may not have established a significant presence in the U.S. market. Without access to proprietary information, a comprehensive assessment of their FDA status cannot be provided.

Specific information regarding Omnicals Pharma's WHO prequalification, EU Good Manufacturing Practice (GMP) certificates, and European Directorate for the Quality of Medicines & HealthCare (EDQM) status is not publicly available. The absence of such data suggests that the company may not have obtained these certifications. Without access to proprietary information, a detailed assessment of their compliance with international quality standards cannot be provided.

Specific information regarding Omnicals Pharma's Central Drugs Standard Control Organisation (CDSCO) manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) is not publicly available. The absence of such data suggests that the company may not have obtained these regulatory approvals. Without access to proprietary information, a comprehensive assessment of their compliance with Indian regulatory requirements cannot be provided.

No publicly available information indicates that Omnicals Pharma has faced any Form 483 observations, warning letters, or import alerts. The absence of such data suggests that the company may not have been subject to significant regulatory actions. Without access to proprietary information, a detailed analysis of their regulatory history cannot be provided.

Specific information regarding Omnicals Pharma's competitors in overlapping therapeutic categories, market share comparisons, and head-to-head analyses is not publicly available. The absence of such data suggests that the company may not have a significant presence in these markets. Without access to proprietary information, a comprehensive assessment of the competitive landscape cannot be provided.

Omnicals Pharma's focus on global pharmaceutical business development and its partnerships with clients holding approvals from regulatory bodies such as the US FDA, UK MHRA, and Australian TGA indicate a commitment to quality and compliance. However, specific details regarding the company's unique strengths, competitive advantages, and product portfolio distinctions are not publicly available. Without access to proprietary information, a detailed analysis of their key differentiators cannot be provided.

Omnicals Pharma's export data indicates a focus on finished pharmaceutical formulations in critical therapeutic areas. However, specific information regarding the company's strategic direction—whether in generics, specialty drugs, biosimilars, or Contract Development and Manufacturing Organization (CDMO) services—is not publicly available. Without access to proprietary information, a comprehensive assessment of their strategic position and future outlook cannot be provided.

Omnicals Pharma's export data indicates a total export value of $3.9 million USD across 86 shipments, with a portfolio concentration of 100% in its top five products. This suggests a focused approach to its product offerings. However, specific information regarding the company's overall track record, export volume consistency, and reliability indicators is not publicly available. Without access to proprietary information, a detailed assessment of their supplier performance cannot be provided.

Importers should verify the following certifications when considering partnerships with pharmaceutical suppliers:

• FDA Approval: Confirm the supplier's facility registration and product approvals through the FDA's official database.

• WHO-GMP Certification: Verify the supplier's compliance with World Health Organization Good Manufacturing Practices by consulting the WHO's official listings.

• EU GMP Certification: Check the supplier's adherence to European Union Good Manufacturing Practices through the European Medicines Agency's (EMA) official records.

• ISO Certification: Ensure the supplier holds relevant ISO certifications by reviewing the International Organization for Standardization's official listings.

When conducting due diligence on potential pharmaceutical suppliers, consider the following steps:

• Verify Regulatory Approvals: Confirm the supplier's compliance with relevant regulatory bodies such as the FDA, WHO, EU, and CDSCO.

• Assess Manufacturing Capabilities: Evaluate the supplier's manufacturing facilities for capacity, quality control measures, and adherence to Good Manufacturing Practices.

• Review Financial Stability: Analyze the supplier's financial statements to assess profitability, revenue trends, and overall financial health.

• Check for Regulatory Actions: Investigate any past or ongoing regulatory actions, including warning letters, import alerts, or compliance issues.

• Evaluate Product Quality: Review product quality records, including batch testing results and quality assurance protocols.

• Assess Supply Chain Reliability: Examine the supplier's supply chain for consistency, lead times, and risk management practices.

Be vigilant for red flags such as inconsistent