DR Reddys Laboratories Limited — Omeprazole Exporter Profile
Indian Pharmaceutical Exporter · #7 for Omeprazole · $11.7M export value · DGFT Verified
DR Reddys Laboratories Limited is the #7 Indian exporter of Omeprazole with $11.7M in export value and 234 verified shipments. DR Reddys Laboratories Limited holds a 1.8% market share in Omeprazole exports across 10 countries. The company exports 37 pharmaceutical products worth $62.4M across 17 therapeutic categories.
DR Reddys Laboratories Limited — Omeprazole Export Profile: Buyers & Destinations
Where Does DR Reddys Laboratories Limited Export Omeprazole?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $6.0M | 177 | 83.0% |
| MEXICO | $377.1K | 8 | 5.2% |
| SOUTH AFRICA | $367.1K | 8 | 5.1% |
| KAZAKHSTAN | $150.0K | 3 | 2.1% |
| NEW ZEALAND | $100.0K | 2 | 1.4% |
| BELARUS | $82.3K | 21 | 1.1% |
| LATVIA | $79.2K | 7 | 1.1% |
| LITHUANIA | $55.1K | 6 | 0.8% |
| VIETNAM | $13.2K | 1 | 0.2% |
| MALDIVES | $6.0K | 1 | 0.1% |
DR Reddys Laboratories Limited exports Omeprazole to 10 countries. The largest destination is UNITED STATES accounting for 83.0% of DR Reddys Laboratories Limited's Omeprazole shipments, followed by MEXICO (5.2%) and SOUTH AFRICA (5.1%). These destinations reflect DR Reddys Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Omeprazole from DR Reddys Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| DR REDDYS LABORATORIES INC | UNITED STATES | $2.0M | 62 |
| DR REDDY SLABORATORIES INC | UNITED STATES | $1.7M | 47 |
| NORTHSTAR DISTRIBUTION CENTER | UNITED STATES | $690.9K | 21 |
| NORTHSTAR DISTRIBUTION CENTER 8912 | UNITED STATES | $671.3K | 23 |
| DR REDDYS LABORATORIES S A | UNITED STATES | $399.3K | 8 |
| PRIORITY HEALTHCARE DISTRIBUTION DB | UNITED STATES | $223.7K | 9 |
| SIEGFRIED RHEIN SADE CV | MEXICO | $200.0K | 4 |
| PRIORITY HEALTHCARE DISTRIBUTION DBA CURASCRIPT SD | UNITED STATES | $200.0K | 4 |
| DRREDDY S LABORATORIES PTY LTD | SOUTH AFRICA | $150.0K | 3 |
| DRREDDY S LABORATORIES PTY LIMITED | SOUTH AFRICA | $150.0K | 3 |
DR Reddys Laboratories Limited supplies Omeprazole to 39 buyers globally. The largest buyer is DR REDDYS LABORATORIES INC (UNITED STATES), followed by DR REDDY SLABORATORIES INC (UNITED STATES) and NORTHSTAR DISTRIBUTION CENTER (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Omeprazole Export Value and How Much Does DR Reddys Laboratories Limited Contribute?
India exported $248.0M worth of Omeprazole through 15,000 shipments from 975 suppliers to 179 countries, serving 2,858 buyers globally. DR Reddys Laboratories Limited contributes $11.7M to this total, accounting for 1.8% of India's Omeprazole exports. DR Reddys Laboratories Limited ships Omeprazole to 10 countries through 39 buyers.
What Is the Average Shipment Value for DR Reddys Laboratories Limited's Omeprazole Exports?
DR Reddys Laboratories Limited's average Omeprazole shipment value is $50.0K per consignment, based on 234 shipments totaling $11.7M. The largest destination is UNITED STATES (83.0% of DR Reddys Laboratories Limited's Omeprazole exports).
How Does DR Reddys Laboratories Limited Compare to Other Indian Omeprazole Exporters?
DR Reddys Laboratories Limited ranks #7 among 975 Indian Omeprazole exporters with a 1.8% market share. The top 3 exporters are SUN PHARMACEUTICAL INDUSTRIES LIMITED ($53.6M), CIPLA LIMITED ($44.0M), DR.REDDY'S LABORATORIES LTD ($35.7M). DR Reddys Laboratories Limited processed 234 shipments to 10 destination countries.
What Omeprazole Formulations Does DR Reddys Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| OMEPRAZOLE MAGNESIUM DELAYED RELEASE | $399.3K | 8 |
| 300038464 OmeprazoleDRCapstUSP20mg1000sQ | $223.7K | 9 |
| OMEPRAZOLE DELAYED-RELEASE CAPSULES USP20MG 1000S 5897 X 1000S PACKS=5897000 NOS | $150.0K | 3 |
| OMEPRAZOLE DR CAPSULES USP 40MG 11520x100's PACK | $103.5K | 5 |
| NAPROXEN AND ESOMEPRAZOLE MG DR TABS 500/20MG 60 S 6024 X 60 S PACKS= 361440 NOS | $100.0K | 2 |
| ESOMEPRAZOLE MAGNESIUM DR CAPSULES USP 40MG 30S 63528 X 30S PACKS=1905840 NOS | $100.0K | 2 |
| OMEZ 40 OMEPRAZOLE CAPSULES 40MG 28SPACK 23664 X 28S PACK | $100.0K | 2 |
| OMEPRAZOLE DELAYED-RELEASE CAPSULES USP40MG 30 S 115248 X 30 S PACKS = 3457440NOS | $100.0K | 2 |
| ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES USP 40 MG 1000 S 1752 X 1000 SPACKS= 1752000 NOS | $88.1K | 2 |
| ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES USP 20 MG 90 S 16968 X 90 S PACKS = 1527120 NOS | $76.3K | 2 |
DR Reddys Laboratories Limited exports 193 distinct Omeprazole formulations including tablets, capsules, syrups, and combination drugs. The top formulation is OMEPRAZOLE MAGNESIUM DELAYED RELEASE with 8 shipments worth $399.3K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Omeprazole to Key Markets
What DR Reddys Laboratories Limited must comply with to export Omeprazole to its top destination countries
United States — FDA
Approval Process
ANDA (Abbreviated New Drug Application) for generics. Indian manufacturing site must pass FDA pre-approval inspection. Drug Master File (DMF) required for APIs.
Timeline: 10–18 months for ANDA approval
GMP & Export Requirements
FDA cGMP compliance (21 CFR 210/211); facility inspection by FDA
Drug Listing with FDA; Export Certificate from CDSCO India; Import Alert screening via FDA PREDICT system
Note: Subject to FDA Import Alerts. Open Form 483 observations can block all exports from a facility.
Mexico — COFEPRIS
Approval Process
Generic registration under Mexican health law. NOM standards apply.
Timeline: 12–18 months
GMP & Export Requirements
Mexican GMP (NOM-059-SSA1); COFEPRIS overseas inspection or PIC/S certificate
Sanitary Import Permit from COFEPRIS; import licence via SAT
Note: COFEPRIS participates in PIC/S, easing recognition of PIC/S certificates from Indian authorities.
South Africa — SAHPRA
Approval Process
Registration under SAHPRA guidelines (CTD format). Bioequivalence required for generics.
Timeline: 24–48 months (significant backlog)
GMP & Export Requirements
WHO GMP or PIC/S GMP compliance
Certificate of Pharmaceutical Product from CDSCO; Import permit per Section 22A of Medicines Act
Note: Known registration backlog. WHO Prequalification significantly assists the process.
Regulatory information is provided for general reference based on publicly available guidelines. Requirements vary by formulation, dosage form, and therapeutic classification. Exporters should consult qualified regulatory affairs professionals for case-specific guidance.
How Does DR Reddys Laboratories Limited Compare to Nearest Omeprazole Exporters?
Exporters ranked immediately above and below #7 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 4 | MICRO LABS LIMITED | $17.2M | 344 | 23 | $50.0K |
| 8 | ZYDUS LIFESCIENCES LIMITED | $13.2M | 313 | 18 | $42.1K |
| 7 | DR REDDYS LABORATORIES LIMITED ★ | $11.7M | 234 | 10 | $50.0K |
| 10 | COMBITIC GLOBAL CAPLET PRIVATE LIMITED | $7.9M | 205 | 3 | $38.4K |
| 5 | MYLAN LABORATORIES LIMITED | $6.7M | 133 | 5 | $50.0K |
DR Reddys Laboratories Limited ranks #7 among 975 Indian Omeprazole exporters. Average shipment value of $50.0K compared to the market average of $254.4K. The closest competitors by value are MICRO LABS LIMITED and ZYDUS LIFESCIENCES LIMITED.
Which Indian Ports Ship Omeprazole Exports?
| Port | Shipments | % Share |
|---|---|---|
| NHAVA SHEVA SEA (INNSA1) | 1,900 | 12.7% |
| SAHAR AIR CARGO ACC (INBOM4) | 1,316 | 8.8% |
| DELHI AIR CARGO ACC (INDEL4) | 857 | 5.7% |
| SAHAR AIR | 837 | 5.6% |
| JNPT/ NHAVA SHEVA SEA | 784 | 5.2% |
| HYDERABAD ICD (INSNF6) | 480 | 3.2% |
| Bombay Air | 463 | 3.1% |
| DELHI AIR | 456 | 3.0% |
What Other Gastrointestinal Products Does DR Reddys Laboratories Limited Export?
DR Reddys Laboratories Limited also exports these gastrointestinal products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on DR Reddys Laboratories Limited's Omeprazole Exports
The global pharmaceutical export landscape has been significantly influenced by recent geopolitical events. The 2026 Strait of Hormuz crisis, initiated by military conflicts involving the United States, Israel, and Iran, led to the effective halt of shipping traffic through this critical maritime route, disrupting approximately 20% of the world's daily oil supply and causing a surge in global energy prices. (en.wikipedia.org) This disruption has had a cascading effect on shipping costs and insurance premiums, directly impacting Indian pharmaceutical exporters like Dr. Reddy's, which rely on these routes for timely delivery of products to key markets.
Simultaneously, the 2025–26 United States–India diplomatic and trade crisis, marked by the imposition of a 50% tariff on Indian exports by the U.S., has posed additional challenges. These tariffs have increased the cost of Indian pharmaceutical products in the U.S. market, potentially affecting the competitiveness of companies like Dr. Reddy's. (en.wikipedia.org)
In the European Union, compliance with the Falsified Medicines Directive (FMD) remains a critical requirement for exporters. Dr. Reddy's has been proactive in adhering to these regulations, ensuring that its products meet the stringent safety and traceability standards mandated by the EU, thereby maintaining its market access and reputation.
DR Reddys Laboratories Limited — Regulatory Compliance & Quality Standards
Compliance with international regulatory standards is paramount for Indian pharmaceutical exporters. Dr. Reddy's has demonstrated a commitment to quality by securing approvals from major regulatory bodies, including the U.S. Food and Drug Administration (FDA), the World Health Organization (WHO), and the European Medicines Agency (EMA). The company's recent Biologics License Application (BLA) submission for a proposed interchangeable biosimilar to Orencia® (abatacept) underscores its adherence to rigorous regulatory processes. (stockwatch.com)
However, the company has faced regulatory challenges, such as the tax audit decision from the Russian Federal Tax Service in January 2026, which reclassified certain marketing services as taxable, resulting in a penalty. (stocktitan.net) Such incidents highlight the complexities of operating in diverse regulatory environments and the importance of robust compliance frameworks.
About DR Reddys Laboratories Limited
DR Reddys Laboratories Limited exports 37 products worth $62.4M. Beyond Omeprazole, top products include Metoprolol, Diclofenac, Clopidogrel, Fexofenadine, Esomeprazole. View the complete DR Reddys Laboratories Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Omeprazole — including regulatory updates, trade policy changes, and competitive landscape analysis — will be available in an upcoming update. This section will feature AI-researched insights from verified industry sources, government notifications, and market reports.
Official References & Regulatory Resources
- CDSCO India
- Pharmexcil
- IBEF — India Pharma Industry
- Ministry of Commerce — Pharma Exports
- India Trade Statistics (DGFT)
Verify manufacturer licensing and export certifications with the official agencies above.
Research Methodology & Data Transparency
Suresh Sormare
Verified AuthorPharmaceutical 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/sureshsormarePrimary 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.
Analysis Methodology
- 1.Product Matching: Omeprazole shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: DR Reddys Laboratories Limited matched across shipments using name normalization, accounting for company name formatting variations.
- 3.Statistical Normalization: Shipment values are statistically normalized to ensure accurate market share representation. This removes the impact of unusually large one-off transactions that could distort company rankings.
- 4.Verified Records: This page is backed by 234 individual customs records matching DR Reddys Laboratories Limited exporting Omeprazole, covering 193 formulations to 10 countries via 39 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 179+ countries, 2,858+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Omeprazole Export Data from DR Reddys Laboratories Limited
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DR Reddys Laboratories Limited
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37 products · $62.4M total trade · 17 categories
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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 for Omeprazole. For current shipment-level data, contact TransData Nexus.