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Indian Pharmaceutical Exporter · Antifungals Specialist · $1.9M Total Trade · DGFT Verified
Orbion Pharmaceuticals Private Limited is an Indian pharmaceutical exporter with a total trade value of $1.9M across 2 products in 2 therapeutic categories. Based on 66 verified export shipments from Indian Customs (DGFT) records, the company actively competes across multiple product segments. Top exports include Terbinafine ($1.1M), Loperamide ($735.1K), .
Orbion Pharmaceuticals Private Limited is a privately held pharmaceutical company established on May 31, 2021, in Kanchipuram, Tamil Nadu, India. The company operates under the Corporate Identification Number (CIN) U24100TN2021FTC143806 and is registered with the Registrar of Companies, Chennai. It is a subsidiary of a foreign company, with an authorized and paid-up capital of ₹175 crore (approximately $23 million USD).
The company's manufacturing facility is located at Plot B5 (Part) & Plot B6 (Part), Sipcot Industrial Park, Irrungatukottai, Sriperumbudur Tal, Kanchipuram, Tamil Nadu, 602117, India. Orbion Pharmaceuticals specializes in the research, development, manufacturing, and marketing of generic pharmaceutical products, focusing on finished dose formulations such as tablets, capsules, syrups, and injections. The company has a global presence, exporting its products to over 40 countries, including the USA, UK, and EU regions.
Orbion Pharmaceuticals Private Limited operates across 2 therapeutic categories, with Antifungals (60.6%), Gastrointestinal (39.4%), representing the largest segments by export value. The portfolio is concentrated — the top 5 products account for 100% of total exports.
Antifungals
1 products · 60.6% · $1.1M
Gastrointestinal
1 products · 39.4% · $735.1K
Orbion Pharmaceuticals Private Limited exports 2 pharmaceutical products across 2 therapeutic categories.
| # | Product | Category | Export Value | Shipments | Market Share | Rank |
|---|---|---|---|---|---|---|
| 1 | Terbinafine | Antifungals | $1.1M | 46 | 4.1% | 7 |
| 2 | Loperamide |
Headquarters, ownership, manufacturing facilities, and key leadership
Orbion Pharmaceuticals Private Limited is a privately held pharmaceutical company established on May 31, 2021, in Kanchipuram, Tamil Nadu, India. The company operates under the Corporate Identification Number (CIN) U24100TN2021FTC143806 and is registered with the Registrar of Companies, Chennai. It is a subsidiary of a foreign company, with an authorized and paid-up capital of ₹175 crore (approximately $23 million USD).
The company's manufacturing facility is located at Plot B5 (Part) & Plot B6 (Part), Sipcot Industrial Park, Irrungatukottai, Sriperumbudur Tal, Kanchipuram, Tamil Nadu, 602117, India. Orbion Pharmaceuticals specializes in the research, development, manufacturing, and marketing of generic pharmaceutical products, focusing on finished dose formulations such as tablets, capsules, syrups, and injections. The company has a global presence, exporting its products to over 40 countries, including the USA, UK, and EU regions.
Orbion Pharmaceuticals operates a state-of-the-art manufacturing facility spanning 4.97 acres, designed to meet the stringent requirements of international markets. The facility is capable of producing up to 1.1 billion tablets and capsules annually, primarily serving customers in the USA and Europe. It comprises four cGMP-compliant manufacturing modules, ensuring adherence to global quality standards. Additionally, the facility includes cGMP-compliant packaging, quality control and stability laboratories, warehousing, and packing areas, all contributing to the company's commitment to quality and regulatory compliance.
| $735.1K |
| 20 |
1.0% |
| 13 |
Orbion Pharmaceuticals Private Limited exports 2 pharmaceutical products across 2 therapeutic categories with a total export value of $1.9M. The top category is Antifungals (60.6% of portfolio), followed by Gastrointestinal (39.4%), indicating a concentrated portfolio with the top 5 products accounting for 100.0% of total export value.
Shipment-level records, pricing & buyer contacts for Orbion Pharmaceuticals Private Limited.
Request DemoThe leadership team at Orbion Pharmaceuticals comprises seasoned professionals with extensive experience in the pharmaceutical industry:
Regulated market presence, emerging market penetration, and geographic strategy
Orbion Pharmaceuticals has established a strong presence in regulated markets, particularly in the USA and the EU. The company has developed and manufactured generic products in the oral solid dosage category (excluding penicillin and cephalosporins) for these regions. As of the latest available data, Orbion has approximately 29 Abbreviated New Drug Applications (ANDAs) and 29 Drug Master Files (DMFs) approved by the US Food and Drug Administration (FDA) and European regulatory agencies. This extensive portfolio underscores Orbion's commitment to meeting the stringent regulatory requirements of these markets.
The company's manufacturing facility is an Export Oriented Unit (EOU), predominantly exporting products to the US and EU markets. It is inspected and approved by various regulatory agencies, including the US FDA and the UK Medicines and Healthcare Regulatory Agency (MHRA). This regulatory compliance ensures that Orbion's products meet the quality and safety standards required for these markets.
Orbion Pharmaceuticals has expanded its reach to emerging markets in Africa, Latin America, and Southeast Asia. The company's adherence to international quality standards, as evidenced by approvals from agencies such as the US FDA and UK MHRA, facilitates its entry into these regions. While specific details regarding WHO prequalification are not provided, the company's global presence and regulatory compliance suggest a strategic approach to penetrating these emerging markets.
Orbion Pharmaceuticals demonstrates a diversified geographic strategy by exporting its products to over 40 countries, including the USA, UK, and EU regions. This broad market presence mitigates concentration risk and positions the company to leverage growth opportunities across different regions. The company's focus on regulated markets, coupled with its adherence to international quality standards, reflects a strategic direction aimed at establishing a strong global footprint.
FDA status, WHO-GMP certification, EU GMP compliance, and regulatory track record
Orbion Pharmaceuticals has achieved significant milestones in the US market, with approximately 29 ANDAs approved by the US FDA. This extensive portfolio indicates the company's capability to develop and manufacture generic pharmaceutical products that meet the FDA's rigorous standards. The manufacturing facility, an Export Oriented Unit (EOU), is inspected and approved by the US FDA, ensuring compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
Orbion Pharmaceuticals' manufacturing facility is an Export Oriented Unit (EOU), predominantly exporting products to the US and EU markets. It is inspected and approved by various regulatory agencies, including the US FDA and the UK Medicines and Healthcare Regulatory Agency (MHRA). While specific details regarding WHO prequalification and EU GMP certificates are not provided, the company's adherence to international quality standards and regulatory approvals suggests compliance with these certifications.
Orbion Pharmaceuticals operates under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) in India. The company's manufacturing facility is an Export Oriented Unit (EOU), indicating compliance with Indian export regulations. Specific details regarding CDSCO manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not provided in the available information. However, the company's adherence to international quality standards and regulatory approvals suggests compliance with Indian regulatory requirements.
As of the latest available data, there are no publicly disclosed Form 483 observations, warning letters, or import alerts associated with Orbion Pharmaceuticals. This absence indicates a favorable regulatory standing and suggests that the company's manufacturing practices align with the expectations of regulatory agencies.
Market share comparison, key differentiators, and strategic analysis
Orbion Pharmaceuticals operates in the competitive generic pharmaceutical market, focusing on finished dose formulations such as tablets, capsules, syrups, and injections. While specific competitors are not identified in the available information, the company's extensive portfolio of approximately 29 ANDAs and 29 DMFs approved by the US FDA and European regulatory agencies positions it as a significant player in the industry. The company's adherence to international quality standards and regulatory approvals further enhances its competitive standing.
Orbion Pharmaceuticals' key differentiators include its vertically integrated business model, covering the entire pharmaceutical value chain from research to distribution. The company's manufacturing facility is an Export Oriented Unit (EOU), predominantly exporting products to the US and EU markets, and is inspected and approved by various regulatory agencies, including the US FDA and the UK MHRA. Additionally, Orbion's extensive portfolio of approximately 29 ANDAs and 29 DMFs approved by the US FDA and European regulatory agencies underscores its capability to meet stringent regulatory standards.
Orbion Pharmaceuticals is strategically positioned as a research-based generic pharmaceutical company with a focus on finished dose formulations. The company's vertically integrated model spans from discovery to distribution, enabling it to maintain control over the entire value chain. With a global presence across over 40 countries and a portfolio of approximately 29 ANDAs and 29 DMFs approved by the US FDA and European regulatory agencies, Orbion is well-positioned to leverage growth opportunities in both developed and emerging markets.
Track record assessment, certifications to verify, and pre-order checks
Orbion Pharmaceuticals has demonstrated a strong track record in the pharmaceutical industry, with a focus on research, development, manufacturing, and marketing of generic pharmaceutical products. The company's manufacturing facility is an Export Oriented Unit (EOU), predominantly exporting products to the US and EU markets, and is inspected and approved by various regulatory agencies, including the US FDA and the UK MHRA.
Orbion Pharmaceuticals Private Limited exports 2 pharmaceutical products across 2 therapeutic categories. The top exports are Terbinafine ($1.1M), Loperamide ($735.1K). Total export value is $1.9M.
Orbion Pharmaceuticals Private Limited's total pharmaceutical export value is $1.9M, based on 66 verified shipments recorded in Indian Customs (DGFT) data.
Orbion Pharmaceuticals Private Limited exports across 2 therapeutic categories. The largest are Antifungals (60.6%, 1 products), Gastrointestinal (39.4%, 1 products).
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.
Verify manufacturer licensing, GMP certification, and export registration with the agencies above.
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.
linkedin.com/in/sureshsormareAll 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.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
2 Products Tracked
2 therapeutic categories
Expert-Reviewed
By pharmaceutical trade specialists
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.