DR Reddys Laboratories Limited — Montelukast Exporter Profile
Indian Pharmaceutical Exporter · #12 for Montelukast · $2.3M export value · DGFT Verified
DR Reddys Laboratories Limited is the #12 Indian exporter of Montelukast with $2.3M in export value and 45 verified shipments. DR Reddys Laboratories Limited holds a 1.3% market share in Montelukast exports across 3 countries. The company exports 37 pharmaceutical products worth $62.4M across 17 therapeutic categories.
DR Reddys Laboratories Limited — Montelukast Export Profile: Buyers & Destinations
Where Does DR Reddys Laboratories Limited Export Montelukast?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.1M | 30 | 64.5% |
| SOUTH AFRICA | $433.6K | 10 | 26.1% |
| UNITED KINGDOM | $157.6K | 5 | 9.5% |
DR Reddys Laboratories Limited exports Montelukast to 3 countries. The largest destination is UNITED STATES accounting for 64.5% of DR Reddys Laboratories Limited's Montelukast shipments, followed by SOUTH AFRICA (26.1%) and UNITED KINGDOM (9.5%). These destinations reflect DR Reddys Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Montelukast from DR Reddys Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| DR REDDYS LABORATORIES INC | UNITED STATES | $597.0K | 20 |
| DR REDDY SLABORATORIES INC | UNITED STATES | $475.3K | 10 |
| DR REDDYS LABORATORIES PTY LIMI | SOUTH AFRICA | $218.0K | 5 |
| MOVIANTO UK LIMITED | UNITED KINGDOM | $157.6K | 5 |
| DRREDDY S LABORATORIES PTY LIMITED | SOUTH AFRICA | $116.4K | 3 |
| DRREDDY S LABORATORIES PTY LTD | SOUTH AFRICA | $99.2K | 2 |
DR Reddys Laboratories Limited supplies Montelukast to 6 buyers globally. The largest buyer is DR REDDYS LABORATORIES INC (UNITED STATES), followed by DR REDDY SLABORATORIES INC (UNITED STATES) and DR REDDYS LABORATORIES PTY LIMI (SOUTH AFRICA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Montelukast Export Value and How Much Does DR Reddys Laboratories Limited Contribute?
India exported $73.6M worth of Montelukast through 6,431 shipments from 510 suppliers to 138 countries, serving 1,324 buyers globally. DR Reddys Laboratories Limited contributes $2.3M to this total, accounting for 1.3% of India's Montelukast exports. DR Reddys Laboratories Limited ships Montelukast to 3 countries through 6 buyers.
What Is the Average Shipment Value for DR Reddys Laboratories Limited's Montelukast Exports?
DR Reddys Laboratories Limited's average Montelukast shipment value is $50.0K per consignment, based on 45 shipments totaling $2.3M. The largest destination is UNITED STATES (64.5% of DR Reddys Laboratories Limited's Montelukast exports).
How Does DR Reddys Laboratories Limited Compare to Other Indian Montelukast Exporters?
DR Reddys Laboratories Limited ranks #12 among 510 Indian Montelukast exporters with a 1.3% market share. The top 3 exporters are UNICHEM LABORATORIES LIMITED ($13.1M), MACLEODS PHARMACEUTICALS LTD ($11.6M), DR.REDDY'S LABORATORIES LTD ($9.4M). DR Reddys Laboratories Limited processed 45 shipments to 3 destination countries.
What Montelukast Formulations Does DR Reddys Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| MONTELUKAST SODIUM TABLETS 10MG 6684 X1000S PACKS=6684000 NOS | $50.0K | 1 |
| MONTELUKAST SODIUM TABLETS 10MG 90 S 92409 X 90 S PACKS= 8316810 NOS | $50.0K | 1 |
| MONTELUKAST SODIUM TABLETS 10MG 85536 X90S PACKS=7698240 NOS | $50.0K | 1 |
| 300027586 TOPRAZ 10 MONTELUKAST 30?S/PACK 49296 PACKSX30'S/PAC=1478880.NOS | $50.0K | 1 |
| MONTELUKAST FILM-COATED TABLETS 10 MG 28S PACKS 50849 X 28S PACKS= 1423772 NOS | $50.0K | 1 |
| MONTELUKAST SODIUM TABLETS 10MG 1000'S 4942 X 1000S PACKS=4942000 NOS | $50.0K | 1 |
| TOPRAZ 4 MONTELUKAST 30S PACKQTY: 26908 PACKS X 30 =807240 | $50.0K | 1 |
| 300027586 TOPRAZ 10 MONTELUKAST SODIUM10MG 30?S/PACK 54707 PACKSX30'S/PAC=1641210.NOS | $50.0K | 1 |
| MONTELUKAST SODIUM TABLETS 10MG 1000 S 10005 X 1000 S PACKS= 10005000 NOS | $50.0K | 1 |
| MONTELUKAST SODIUM TABLETS 10MG 90 S 49083 X 90 S PACKS= 4417470 NOS | $50.0K | 1 |
DR Reddys Laboratories Limited exports 43 distinct Montelukast formulations including tablets, capsules, syrups, and combination drugs. The top formulation is MONTELUKAST SODIUM TABLETS 10MG 6684 X1000S PACKS=6684000 NO with 1 shipments worth $50.0K.
Regulatory Requirements: Exporting Montelukast to Key Markets
What DR Reddys Laboratories Limited must comply with to export Montelukast 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.
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.
United Kingdom — MHRA
Approval Process
Post-Brexit UK Marketing Authorisation via national procedure. Separate from EU approval since January 2021.
Timeline: 12–15 months
GMP & Export Requirements
UK GMP compliance; MHRA inspection of manufacturing site
Manufacturer Import Authorisation (MIA) held by UK importer; Qualified Person (QP) batch release
Note: Post-Brexit: EU GMP certificates no longer automatically valid in UK. Separate MHRA recognition required.
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 Montelukast Exporters?
Exporters ranked immediately above and below #12 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 9 | INDOCO REMEDIES LIMITED | $3.0M | 61 | 2 | $50.0K |
| 7 | HETERO LABS LIMITED | $2.9M | 58 | 8 | $50.0K |
| 12 | DR REDDYS LABORATORIES LIMITED ★ | $2.3M | 45 | 3 | $50.0K |
| 14 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $1.9M | 106 | 6 | $17.5K |
| 15 | MICRO LABS LIMITED | $1.8M | 45 | 7 | $39.4K |
DR Reddys Laboratories Limited ranks #12 among 510 Indian Montelukast exporters. Average shipment value of $50.0K compared to the market average of $144.3K. The closest competitors by value are INDOCO REMEDIES LIMITED and HETERO LABS LIMITED.
Which Indian Ports Ship Montelukast Exports?
| Port | Shipments | % Share |
|---|---|---|
| DELHI AIR CARGO ACC (INDEL4) | 537 | 8.4% |
| NHAVA SHEVA SEA (INNSA1) | 528 | 8.2% |
| SAHAR AIR | 479 | 7.4% |
| SAHAR AIR CARGO ACC (INBOM4) | 466 | 7.2% |
| DELHI AIR | 451 | 7.0% |
| JNPT/ NHAVA SHEVA SEA | 286 | 4.4% |
| JNPT | 224 | 3.5% |
| MUNDRA SEA | 214 | 3.3% |
Geopolitical & Trade Policy Impact on DR Reddys Laboratories Limited's Montelukast 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 Montelukast, top products include Omeprazole, Metoprolol, Diclofenac, Clopidogrel, Fexofenadine. View the complete DR Reddys Laboratories Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Montelukast — 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: Montelukast 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 45 individual customs records matching DR Reddys Laboratories Limited exporting Montelukast, covering 43 formulations to 3 countries via 6 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 138+ countries, 1,324+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Montelukast 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 Montelukast. For current shipment-level data, contact TransData Nexus.