Dr.reddy's Laboratories Ltd — Montelukast Exporter Profile
Indian Pharmaceutical Exporter · #4 for Montelukast · $9.4M export value · DGFT Verified
Dr.reddy's Laboratories Ltd is the #4 Indian exporter of Montelukast with $9.4M in export value and 219 verified shipments. Dr.reddy's Laboratories Ltd holds a 5.6% market share in Montelukast exports across 4 countries.
Dr.reddy's Laboratories Ltd — Montelukast Export Profile: Buyers & Destinations
Where Does Dr.reddy's Laboratories Ltd Export Montelukast?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $4.8M | 152 | 69.8% |
| SOUTH AFRICA | $1.2M | 41 | 17.5% |
| UNITED KINGDOM | $854.0K | 38 | 12.5% |
| AUSTRIA | $18.4K | 1 | 0.3% |
Dr.reddy's Laboratories Ltd exports Montelukast to 4 countries. The largest destination is UNITED STATES accounting for 69.8% of Dr.reddy's Laboratories Ltd's Montelukast shipments, followed by SOUTH AFRICA (17.5%) and UNITED KINGDOM (12.5%). These destinations reflect Dr.reddy's Laboratories Ltd's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Montelukast from Dr.reddy's Laboratories Ltd?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| DR. REDDYS LABORATORIES, INC | UNITED STATES | $1.8M | 46 |
| DR REDDYS LABORATORIES,INC | UNITED STATES | $710.1K | 24 |
| DR.REDDY'S LABORATORIES (PTY) LIMIT | SOUTH AFRICA | $556.9K | 23 |
| MOVIANTO UK LTD | UNITED KINGDOM | $521.4K | 24 |
| DR. REDDYS LABORATORIES INC | UNITED STATES | $420.0K | 12 |
| DR. REDDY'S LABORATORIES, INC | UNITED STATES | $419.9K | 16 |
| MOVIANTO UK LTD, | UNITED KINGDOM | $329.5K | 11 |
| DR REDDYS LABORATORIES INC | UNITED STATES | $301.0K | 8 |
| DR.REDDY'S LABORATORIES INC | UNITED STATES | $194.0K | 9 |
| DR.REDDYS LABORATORIES,INC | UNITED STATES | $163.8K | 4 |
Dr.reddy's Laboratories Ltd supplies Montelukast to 33 buyers globally. The largest buyer is DR. REDDYS LABORATORIES, INC (UNITED STATES), followed by DR REDDYS LABORATORIES,INC (UNITED STATES) and DR.REDDY'S LABORATORIES (PTY) LIMIT (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.reddy's Laboratories Ltd Contribute?
India exported $73.6M worth of Montelukast through 6,431 shipments from 510 suppliers to 138 countries, serving 1,324 buyers globally. Dr.reddy's Laboratories Ltd contributes $9.4M to this total, accounting for 5.6% of India's Montelukast exports. Dr.reddy's Laboratories Ltd ships Montelukast to 4 countries through 33 buyers.
What Is the Average Shipment Value for Dr.reddy's Laboratories Ltd's Montelukast Exports?
Dr.reddy's Laboratories Ltd's average Montelukast shipment value is $43.0K per consignment, based on 219 shipments totaling $9.4M. The largest destination is UNITED STATES (69.8% of Dr.reddy's Laboratories Ltd's Montelukast exports).
How Does Dr.reddy's Laboratories Ltd Compare to Other Indian Montelukast Exporters?
Dr.reddy's Laboratories Ltd ranks #4 among 510 Indian Montelukast exporters with a 5.6% 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.reddy's Laboratories Ltd processed 219 shipments to 4 destination countries.
What Montelukast Formulations Does Dr.reddy's Laboratories Ltd Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| MONTELUKAST SODIUM TABLETS 10MG 1000S ( | $633.1K | 14 |
| MONTELUKAST SODIUM TABLETS 10MG 90S (TO | $367.0K | 8 |
| 300027543 TOPRAZ 4 (MONTELUKAST) (20028X30'S) | $183.0K | 6 |
| MONTELUKAST SODIUM TABLETS 10MG (11701X 1000'S=11701000)NOS | $144.0K | 3 |
| 300016142 MONTELUKAST SODIUM TABLETS 10MG 90S (92592 SU X 90=8333280 NOS)NOS | $135.9K | 3 |
| MONTELUKAST SODIUM TABLETS 10MG 1000S | $126.0K | 6 |
| 300027586 TOPROZ 10 (MONTELUKAST) (30S P | $118.5K | 8 |
| MONTELUKAST SODIUM TABLETS 10 MG (8322 PACKS X 1000'S= 8322000 NOS) | $111.3K | 3 |
| MONTELUKAST SODIUM TABLETS 10MG (56184 X90'S PACK = 5056560 NO'S) | $100.0K | 2 |
| 300027585 TOPRAZ 5(MONTELUKAST) (10752X30'S) | $98.2K | 6 |
Dr.reddy's Laboratories Ltd exports 130 distinct Montelukast formulations including tablets, capsules, syrups, and combination drugs. The top formulation is MONTELUKAST SODIUM TABLETS 10MG 1000S ( with 14 shipments worth $633.1K.
Regulatory Requirements: Exporting Montelukast to Key Markets
What Dr.reddy's Laboratories Ltd 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.reddy's Laboratories Ltd Compare to Nearest Montelukast Exporters?
Exporters ranked immediately above and below #4 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | UNICHEM LABORATORIES LIMITED | $13.1M | 262 | 3 | $50.0K |
| 1 | MACLEODS PHARMACEUTICALS LTD | $11.6M | 231 | 16 | $50.0K |
| 4 | DR.REDDY'S LABORATORIES LTD ★ | $9.4M | 219 | 4 | $43.0K |
| 3 | AJANTA PHARMA LIMITED | $6.4M | 128 | 5 | $50.0K |
| 6 | TORRENT PHARMACEUTICALS LTD | $5.4M | 221 | 14 | $24.6K |
Dr.reddy's Laboratories Ltd ranks #4 among 510 Indian Montelukast exporters. Average shipment value of $43.0K compared to the market average of $144.3K. The closest competitors by value are UNICHEM LABORATORIES LIMITED and MACLEODS PHARMACEUTICALS LTD.
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% |
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.reddy's Laboratories Ltd 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 232 individual customs records matching Dr.reddy's Laboratories Ltd exporting Montelukast, covering 130 formulations to 4 countries via 33 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
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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.