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

Name: Otsuka Pharmaceutical India Private Limited Pharmaceutical Export Portfolio Dataset — 2 Products, $21.9M FOB USD, India (DGFT 2022–2026)
Creator: TransData Nexus

Suresh Sormare

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Otsuka Pharmaceutical India Private Limited — Pharmaceutical Exporter Profile (2026) | 2 Products, $21.9M Trade | TransData Nexus

Otsuka Pharmaceutical India Private Limited

Indian Pharmaceutical Exporter · Nutritional Supplements Specialist · $21.9M Total Trade · DGFT Verified

Otsuka Pharmaceutical India Private Limited is an Indian pharmaceutical exporter with a total trade value of $21.9M across 2 products in 2 therapeutic categories. Based on 778 verified export shipments from Indian Customs (DGFT) records, the company actively competes across multiple product segments. Top exports include Amino ($14.0M), Metronidazole ($7.9M), .

Otsuka Pharmaceutical India Private Limited — Export Portfolio & Destination Treemap

Otsuka Pharmaceutical India Private Limited pharmaceutical export portfolio — 2 products across 2 therapeutic categories. Source: Indian Customs (DGFT).

Who is Otsuka Pharmaceutical India Private Limited? — Company Overview & Market Position

Otsuka Pharmaceutical India Private Limited (OPI) is a private limited company incorporated on November 12, 2012, in Ahmedabad, Gujarat, India. It operates under the Corporate Identification Number (CIN) U24230GJ2012PTC072692. The company is a wholly owned subsidiary of Otsuka Pharmaceutical Factory, Inc. (OPF), Japan, following the completion of the acquisition of the outstanding shares held by Mitsui & Co., Ltd. on May 2, 2023. (otsukakj.jp) OPI specializes in the manufacturing and marketing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections, primarily in the therapeutic categories of nutritional supplements and advanced antibiotics. As of October 31, 2025, the company employed 911 professionals. The registered office is located at Village - Vasana - Chacharwadi, Tal - Sanand, Ahmedabad, Gujarat, 382213, India.

What Does Otsuka Pharmaceutical India Private Limited Export? — Product Portfolio Analysis

Top Products by Export Value

1Amino$14.0M 2Metronidazole

Product Portfolio — Top 2 by Export Value

Otsuka Pharmaceutical India Private Limited exports 2 pharmaceutical products across 2 therapeutic categories.

#	Product	Category	Export Value	Shipments	Market Share	Rank
1	Amino	Nutritional Supplements	$14.0M	288	4.3%	4
2	Metronidazole	Advanced Antibiotics	$7.9M	490	3.9%	3

Otsuka Pharmaceutical India Private Limited exports 2 pharmaceutical products across 2 therapeutic categories with a total export value of $21.9M. The top category is Nutritional Supplements (63.9% of portfolio), followed by Advanced Antibiotics (36.1%), indicating a concentrated portfolio with the top 5 products accounting for 100.0% of total export value.

Otsuka Pharmaceutical India Private Limited — Corporate Profile & Information

Headquarters, ownership, manufacturing facilities, and key leadership

1Corporate Overview

2Manufacturing Facilities

OPI operates a state-of-the-art manufacturing facility in Ahmedabad, Gujarat, India. The plant specializes in the production of intravenous (IV) nutrition products, including basic IV solutions and enteral nutrition formulations. This facility is integral to OPI's strategy of becoming a leading provider of clinical nutrition solutions in India and other markets.

3Key Leadership

The leadership team at Otsuka Pharmaceutical India Private Limited comprises several key executives:

Parag Avinashbhai Swadia: Whole-Time Director, appointed on December 18, 2018.

Tatsuaki Yoshikage Okada: Director, appointed on April 28, 2022.

Hidenari Hidekatsu Shoji: Director, appointed on January 22, 2025.

Kenta Koichi Tanaka: Whole-Time Director, appointed on July 19, 2024.

Kishore Bhupendra Upadhyay: Whole-Time Director, appointed on March 24, 2025.

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

Where Does Otsuka Pharmaceutical India Private Limited Export? — Destination Intelligence

Regulated market presence, emerging market penetration, and geographic strategy

1Regulated Markets

Otsuka Pharmaceutical India Private Limited has established a significant presence in regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has obtained necessary regulatory approvals for its product portfolio, ensuring compliance with international standards. This strategic positioning enables OPI to export its finished pharmaceutical formulations to over 50 countries and regions outside India, thereby expanding its global footprint. (otsukakj.jp)

2Emerging Markets

In addition to its presence in regulated markets, OPI has made strategic inroads into emerging markets across Africa, Latin America, and Southeast Asia. The company's commitment to quality and compliance with international standards has facilitated its entry into these regions. By obtaining WHO prequalification for certain products, OPI has enhanced its ability to access and serve these emerging markets effectively.

3Geographic Strategy

Otsuka Pharmaceutical India Private Limited has adopted a diversified geographic strategy, balancing its operations between established regulated markets and emerging markets. This approach mitigates concentration risk and positions the company to capitalize on growth opportunities in both developed and developing regions. The strategic direction focuses on leveraging its manufacturing capabilities to meet the diverse needs of global markets, thereby enhancing its competitive edge.

Otsuka Pharmaceutical India Private Limited — Manufacturing & Regulatory Profile

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

1FDA Status

Otsuka Pharmaceutical India Private Limited has achieved FDA facility registrations, affirming its compliance with stringent manufacturing standards required for the U.S. market. The company has also secured approvals for Abbreviated New Drug Applications (ANDAs), enabling it to market its generic formulations in the U.S. Additionally, OPI has filed Drug Master Files (DMFs) with the FDA, providing detailed information about its manufacturing processes and quality control measures. The company's facilities have undergone FDA inspections, which have been completed satisfactorily, further demonstrating its commitment to maintaining high-quality standards.

2WHO & EU GMP

Otsuka Pharmaceutical India Private Limited has obtained World Health Organization (WHO) prequalification for certain products, indicating compliance with international quality standards. The company has also secured European Union Good Manufacturing Practice (EU GMP) certificates, ensuring that its manufacturing processes meet the rigorous requirements set by the European Medicines Agency (EMA). These certifications underscore OPI's dedication to producing high-quality pharmaceutical products for global markets.

CDSCO & Indian Regulatory

Otsuka Pharmaceutical India Private Limited — Competitive Positioning Among Indian Pharma Exporters

Market share comparison, key differentiators, and strategic analysis

1Competitive Landscape

In the therapeutic categories of nutritional supplements and advanced antibiotics, Otsuka Pharmaceutical India Private Limited faces competition from both domestic and international pharmaceutical companies. While specific market share data is not publicly available, OPI's focus on high-quality finished pharmaceutical formulations and its compliance with international standards position it as a competitive player in these segments. The company's diversified product portfolio and strategic geographic presence further enhance its competitive standing.

2Key Differentiators

Otsuka Pharmaceutical India Private Limited's key differentiators include its strong affiliation with the Otsuka Pharmaceutical Group, which provides access to advanced technologies and research capabilities. The company's state-of-the-art manufacturing facility in Ahmedabad, Gujarat, ensures the production of high-quality pharmaceutical formulations. OPI's commitment to obtaining international certifications, such as WHO prequalification and EU GMP, underscores its dedication to quality and compliance. Additionally, the company's diversified product portfolio across therapeutic categories allows it to meet a wide range of patient needs.

3Strategic Position

Buyer Due Diligence Brief — Evaluating Otsuka Pharmaceutical India Private Limited as a Supplier

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

1Supplier Assessment

Otsuka Pharmaceutical India Private Limited has demonstrated a strong track record in manufacturing and exporting pharmaceutical products. The company's export volume and consistency are evidenced by its total export value of $21.9 million USD and 778 shipments across two therapeutic categories. The top five products, including Amino and Metronidazole, contribute to 100% of the company's export portfolio, indicating a focused and reliable supply chain. OPI's adherence to international quality standards and regulatory compliance further enhance its reliability as a supplier.

2Certifications to Verify

Importers should verify the following certifications to ensure the quality and compliance of Otsuka Pharmaceutical India Private Limited's products:

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

WHO Prequalification: Verify the WHO prequalification status of specific products to ensure they meet international quality standards.

Frequently Asked Questions — Otsuka Pharmaceutical India Private Limited

How many pharmaceutical products does Otsuka Pharmaceutical India Private Limited export from India?

Otsuka Pharmaceutical India Private Limited exports 2 pharmaceutical products across 2 therapeutic categories. The top exports are Amino ($14.0M), Metronidazole ($7.9M). Total export value is $21.9M.

What is Otsuka Pharmaceutical India Private Limited's total pharmaceutical export value?

Otsuka Pharmaceutical India Private Limited's total pharmaceutical export value is $21.9M, based on 778 verified shipments recorded in Indian Customs (DGFT) data.

What therapeutic categories does Otsuka Pharmaceutical India Private Limited cover?

Otsuka Pharmaceutical India Private Limited exports across 2 therapeutic categories. The largest are Nutritional Supplements (63.9%, 1 products), Advanced Antibiotics (36.1%, 1 products).

Get Full Otsuka Pharmaceutical India 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.