Simpex Pharma Private Limited Pharmaceutical Export Profile — India (DGFT 2022–2026)

Name: Simpex Pharma Private Limited Pharmaceutical Export Portfolio Dataset — 2 Products, $351.0K FOB USD, India (DGFT 2022–2026)
Creator: TransData Nexus

Suresh Sormare

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Simpex Pharma Private Limited — Pharmaceutical Exporter Profile (2026) | 2 Products, $351.0K Trade | TransData Nexus

Simpex Pharma Private Limited

Indian Pharmaceutical Exporter · Tuberculosis Medications Specialist · $351.0K Total Trade · DGFT Verified

Simpex Pharma Private Limited is an Indian pharmaceutical exporter with a total trade value of $351.0K across 2 products in 2 therapeutic categories. Based on 16 verified export shipments from Indian Customs (DGFT) records, the company actively competes across multiple product segments. Top exports include Pyrazinamide ($194.8K), Ornidazole ($156.2K), .

Simpex Pharma Private Limited — Export Portfolio & Destination Treemap

Simpex Pharma Private Limited pharmaceutical export portfolio — 2 products across 2 therapeutic categories. Source: Indian Customs (DGFT).

Who is Simpex Pharma Private Limited? — Company Overview & Market Position

Simpex Pharma Private Limited, established on March 7, 1997, is a privately held pharmaceutical company headquartered in New Delhi, India. The company is registered under the Corporate Identification Number (CIN) U33112DL1997PTC085657 and is classified as a private limited company. It has an authorized and paid-up capital of ₹2.50 crore.

The company's registered office is located at Flat No-302, 3rd Floor, Ansal Tower, 38, New Delhi, Delhi, 110019. Simpex Pharma specializes in the manufacturing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections, focusing on therapeutic areas such as tuberculosis and advanced antibiotics. The company has a workforce of approximately 157 employees.

What Does Simpex Pharma Private Limited Export? — Product Portfolio Analysis

Top Products by Export Value

1Pyrazinamide$194.8K 2Ornidazole$156.2K

Product Portfolio — Top 2 by Export Value

Simpex Pharma Private Limited exports 2 pharmaceutical products across 2 therapeutic categories.

#	Product	Category	Export Value	Shipments	Market Share	Rank
1	Pyrazinamide	Tuberculosis Medications	$194.8K	6	0.0%	10
2	Ornidazole	Advanced Antibiotics	$156.2K	10	0.9%	15

Simpex Pharma Private Limited exports 2 pharmaceutical products across 2 therapeutic categories with a total export value of $351.0K. The top category is Tuberculosis Medications (55.5% of portfolio), followed by Advanced Antibiotics (44.5%), indicating a concentrated portfolio with the top 5 products accounting for 100.0% of total export value.

Simpex Pharma Private Limited — Corporate Profile & Information

Headquarters, ownership, manufacturing facilities, and key leadership

1Corporate Overview

2Manufacturing Facilities

Simpex Pharma operates a state-of-the-art manufacturing facility located in the foothills of the Himalayas, near Kotdwar in Uttarakhand, approximately 235 kilometers from New Delhi. This facility spans 16,000 square meters and is designed to comply with global Good Manufacturing Practice (GMP) standards. The plant specializes in the production of solid oral dosage forms, including tablets and capsules. It is equipped with modern equipment and adheres to stringent quality control measures to ensure the production of high-quality pharmaceutical products.

3Key Leadership

The leadership team at Simpex Pharma Private Limited comprises:

Naresh Santhanam: Director since February 15, 2010.
Ajay Kumar Mishra: Director since April 6, 2010.
Piyush Kumar Singh: Director since January 2, 2020.

These individuals bring a wealth of experience and expertise to the company's strategic direction and operations.

TransData Nexus Research · Government registries, company filings, regulatory databasesMar 2026

Where Does Simpex Pharma Private Limited Export? — Destination Intelligence

Regulated market presence, emerging market penetration, and geographic strategy

1Regulated Markets

Simpex Pharma Private Limited has made significant strides in expanding its presence in regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's manufacturing facility in Uttarakhand is WHO-GMP approved, which is a critical requirement for market access in these regions. This certification indicates that the facility adheres to international standards of quality and safety, facilitating the export of pharmaceutical products to these markets.

2Emerging Markets

In addition to its presence in regulated markets, Simpex Pharma has been actively exploring opportunities in emerging markets across Africa, Latin America, and Southeast Asia. The WHO-GMP certification of its manufacturing facility enhances the company's ability to meet the regulatory requirements of these regions, thereby facilitating market entry and expansion. This strategic focus aligns with the company's objective to diversify its market presence and tap into the growing demand for pharmaceutical products in these regions.

3Geographic Strategy

Simpex Pharma Private Limited — Manufacturing & Regulatory Profile

FDA status, WHO-GMP certification, EU GMP compliance, and regulatory track record

1FDA Status

As of March 2026, specific details regarding Simpex Pharma'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 WHO-GMP certification of its manufacturing facility suggests a commitment to meeting international quality standards, which is a prerequisite for FDA approvals. However, without explicit information on FDA-related filings and approvals, a comprehensive assessment of the company's FDA status cannot be provided at this time.

2WHO & EU GMP

Simpex Pharma's manufacturing facility in Uttarakhand holds WHO-GMP certification, indicating compliance with international standards for pharmaceutical manufacturing. This certification is essential for exporting products to various international markets, including the European Union. While the WHO-GMP certification is a significant step towards meeting EU GMP requirements, obtaining EU GMP certification would further enhance the company's credibility and market access within the European Union. As of March 2026, specific details regarding EU GMP certification are not publicly available.

3CDSCO & Indian Regulatory

Simpex Pharma Private Limited — Competitive Positioning Among Indian Pharma Exporters

Market share comparison, key differentiators, and strategic analysis

1Competitive Landscape

Simpex Pharma Private Limited operates in a competitive pharmaceutical industry, with several key players in the tuberculosis medications and advanced antibiotics segments. While specific market share data is not publicly available, the company's focus on high-quality manufacturing and adherence to international standards positions it favorably in the market. The WHO-GMP certification of its manufacturing facility further enhances its competitive edge by ensuring product quality and safety.

2Key Differentiators

Simpex Pharma's key differentiators include its WHO-GMP certified manufacturing facility, which ensures compliance with international quality standards, and its focus on research and innovation, leading to the development of over 150 products with an additional 50 in the pipeline. These strengths enable the company to address challenging therapeutic needs and maintain a competitive edge in the pharmaceutical industry.

3Strategic Position

Simpex Pharma Private Limited's current strategic direction emphasizes the production of high-quality pharmaceutical formulations, with a focus on therapeutic areas such as tuberculosis and advanced antibiotics. The company's WHO-GMP certified manufacturing facility supports this strategy by ensuring compliance with international standards. Looking ahead, the company aims to expand its product portfolio and market presence, leveraging its manufacturing capabilities and commitment to quality to meet the evolving needs of the global pharmaceutical market.

Buyer Due Diligence Brief — Evaluating Simpex Pharma Private Limited as a Supplier

Track record assessment, certifications to verify, and pre-order checks

1Supplier Assessment

Simpex Pharma Private Limited demonstrates a strong track record in pharmaceutical manufacturing, with a focus on high-quality finished formulations. The company's WHO-GMP certified manufacturing facility indicates a commitment to international quality standards. While specific export volumes and consistency metrics are not publicly available, the company's strategic focus on regulated and emerging markets suggests a reliable and consistent supply chain.

2Certifications to Verify

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

WHO-GMP Certification: Confirms adherence to international manufacturing standards.
EU GMP Certification: Validates compliance with European Union manufacturing standards.
FDA Facility Registration: Indicates eligibility for exporting to the United States.

These certifications can typically be verified through the respective regulatory bodies' official websites or by requesting copies directly from the manufacturer.

Frequently Asked Questions — Simpex Pharma Private Limited

How many pharmaceutical products does Simpex Pharma Private Limited export from India?

Simpex Pharma Private Limited exports 2 pharmaceutical products across 2 therapeutic categories. The top exports are Pyrazinamide ($194.8K), Ornidazole ($156.2K). Total export value is $351.0K.

What is Simpex Pharma Private Limited's total pharmaceutical export value?

Simpex Pharma Private Limited's total pharmaceutical export value is $351.0K, based on 16 verified shipments recorded in Indian Customs (DGFT) data.

What therapeutic categories does Simpex Pharma Private Limited cover?

Simpex Pharma Private Limited exports across 2 therapeutic categories. The largest are Tuberculosis Medications (55.5%, 1 products), Advanced Antibiotics (44.5%, 1 products).

Get Full Simpex Pharma Private Limited Export Intelligence

Access shipment-level details, pricing data, buyer connections, product breakdown, and competitive analysis. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.

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Official References & Regulatory Resources

Verify manufacturer licensing, GMP certification, and export registration with the agencies above.

Research Methodology & Data Transparency

Suresh Sormare

Verified Author

Pharmaceutical Export-Import Analyst & Trade Intelligence Expert

Suresh Sormare is a pharmaceutical export-import analyst with deep expertise in Indian Customs (DGFT) data, HS code classification, and global pharmaceutical supply chains. His analysis covers 10M+ shipment records across 150+ countries and is used by manufacturers, procurement agencies, and trade consultants worldwide. Suresh specializes in identifying verified suppliers and buyers from customs records, mapping bilateral pharmaceutical trade corridors, analyzing tariff structures and regulatory frameworks across 170+ destination markets, and benchmarking competitive positioning for finished pharmaceutical formulations. His methodology combines granular customs transaction data with regulatory intelligence from FDA, EMA, WHO, CDSCO, and 40+ national drug authorities to deliver actionable trade insights for the pharmaceutical formulations sector.

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Primary Data Source

All trade data is sourced from Indian Customs (DGFT) official shipping bill records — the authoritative government database for India's pharmaceutical trade. Each verified record contains exporter name, consignee (buyer) name, detailed product description, quantity, declared FOB value (USD), port of loading, destination country, and shipment date.

Data Source & Methodology

Trade data sourced from Indian Customs (DGFT) export shipment records. Values represent FOB export value in USD. Market share calculated relative to total Indian pharmaceutical exports per product category. For current shipment-level data, contact TransData Nexus.