SUN Pharmaceutical Industries Limited — Montelukast Exporter Profile
Indian Pharmaceutical Exporter · #14 for Montelukast · $1.9M export value · DGFT Verified
SUN Pharmaceutical Industries Limited is the #14 Indian exporter of Montelukast with $1.9M in export value and 106 verified shipments. SUN Pharmaceutical Industries Limited holds a 1.1% market share in Montelukast exports across 6 countries. The company exports 118 pharmaceutical products worth $979.8M across 25 therapeutic categories.
SUN Pharmaceutical Industries Limited — Montelukast Export Profile: Buyers & Destinations
Where Does SUN Pharmaceutical Industries Limited Export Montelukast?
| Country | Value | Shipments | Share |
|---|---|---|---|
| BELGIUM | $755.4K | 53 | 45.9% |
| BRAZIL | $333.0K | 32 | 20.2% |
| CANADA | $302.1K | 12 | 18.4% |
| MOROCCO | $214.9K | 9 | 13.1% |
| PERU | $22.5K | 2 | 1.4% |
| LEBANON | $14.6K | 1 | 0.9% |
| VIETNAM | $3.3K | 1 | 0.2% |
| SOMAALIA | $62 | 1 | 0.0% |
SUN Pharmaceutical Industries Limited exports Montelukast to 8 countries. The largest destination is BELGIUM accounting for 45.9% of SUN Pharmaceutical Industries Limited's Montelukast shipments, followed by BRAZIL (20.2%) and CANADA (18.4%). These destinations reflect SUN Pharmaceutical Industries Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Montelukast from SUN Pharmaceutical Industries Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| YUSEN LOGISTICS BENELUX BELGIUM | BELGIUM | $676.1K | 44 |
| M/S. SUN PHARMA CANADA INC | CANADA | $200.7K | 8 |
| M/S. RANBAXY FARMACEUTICA LTDA : | BRAZIL | $186.7K | 21 |
| M/S. SUN PHARMACEUTICALS MOROCCO LL | MOROCCO | $179.0K | 7 |
| M S RANBAXY FARMACEUTICA LTDA | BRAZIL | $72.5K | 2 |
| MS SUN PHARMA CANADA INC | CANADA | $51.3K | 3 |
| YUSEN LOGISTICS BENELUX BELGIUM KEETBERGLAAN | BELGIUM | $51.2K | 4 |
| TARO PHARMACEUTICALS INC., | CANADA | $50.0K | 1 |
| SUN PHARMACEUTICALS MOROCCO LL | MOROCCO | $33.1K | 1 |
| M/S. RANBAXYFARMACEUTICA LTDA | BRAZIL | $30.3K | 1 |
SUN Pharmaceutical Industries Limited supplies Montelukast to 22 buyers globally. The largest buyer is YUSEN LOGISTICS BENELUX BELGIUM (BELGIUM), followed by M/S. SUN PHARMA CANADA INC (CANADA) and M/S. RANBAXY FARMACEUTICA LTDA : (BRAZIL). 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 SUN Pharmaceutical Industries Limited Contribute?
India exported $73.6M worth of Montelukast through 6,431 shipments from 510 suppliers to 138 countries, serving 1,324 buyers globally. SUN Pharmaceutical Industries Limited contributes $1.9M to this total, accounting for 1.1% of India's Montelukast exports. SUN Pharmaceutical Industries Limited ships Montelukast to 8 countries through 22 buyers.
What Is the Average Shipment Value for SUN Pharmaceutical Industries Limited's Montelukast Exports?
SUN Pharmaceutical Industries Limited's average Montelukast shipment value is $17.5K per consignment, based on 106 shipments totaling $1.9M. The largest destination is BELGIUM (45.9% of SUN Pharmaceutical Industries Limited's Montelukast exports).
How Does SUN Pharmaceutical Industries Limited Compare to Other Indian Montelukast Exporters?
SUN Pharmaceutical Industries Limited ranks #14 among 510 Indian Montelukast exporters with a 1.1% market share. The top 3 exporters are UNICHEM LABORATORIES LIMITED ($13.1M), MACLEODS PHARMACEUTICALS LTD ($11.6M), DR.REDDY'S LABORATORIES LTD ($9.4M). SUN Pharmaceutical Industries Limited processed 106 shipments to 6 destination countries.
What Montelukast Formulations Does SUN Pharmaceutical Industries Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| MONTELUKAST SODIUM CHEWABLE TABLETS 5MG | $115.9K | 5 |
| MONTELUKAST SODIUM CHEWABLE TABLETS 4MG | $115.0K | 5 |
| TARO-MONTELUKAST TAB 10MG PACK: 100s Bot | $75.9K | 2 |
| MONTELUKAST SODIUM TAB 10MG 3X10S BRAZ PACK Box3x10s Batch DFE0886A DFE0887A EACH TAB CONTS MONTELUKAST SODIUM CHE | $50.0K | 1 |
| TARO-MONTELUKAST TAB 10MG PACK:30s STRIP | $50.0K | 1 |
| ROMILAST CHEWABLE TABS 5MG PACK:BOX3X10SBATCH:BRE01213B EACH CHEWABLE TAB CONTS. MONTELUKAST SODIUM 5MG | $50.0K | 1 |
| MONTELUKAST RANBAXY TAB 10MG ( MONTELUKAST TAB 10MG ) PACK : 4X7S BATCH : DFF3267A, DFF3268A, DFF3269A EACH TAB CONTS: M | $50.0K | 1 |
| MONTELUKAST RANBAXY TAB 10MG ( MONTELUKAST TAB 10MG ) PACK : 4X7S BATCH : DFF3980A, DFF4032A, DFF4033A EACH TABLET CONTS | $50.0K | 1 |
| TARO-MONTELUKAST TABLETS 10MG (MONTELUKAST SODIUM TABLETS 10MG) [5167 PACK X 100'S BOTTLES] (BATCH NO. DFG1248A MFG DT: | $50.0K | 1 |
| ROMILAST CHEWABLE TABS 4MG PACK:BOX3X10SBATCH:BRE01212A EACH CHEWABLE TAB CONTS. MONTELUKAST SODIUM 4MG | $34.2K | 1 |
SUN Pharmaceutical Industries Limited exports 89 distinct Montelukast formulations including tablets, capsules, syrups, and combination drugs. The top formulation is MONTELUKAST SODIUM CHEWABLE TABLETS 5MG with 5 shipments worth $115.9K.
Regulatory Requirements: Exporting Montelukast to Key Markets
What SUN Pharmaceutical Industries Limited must comply with to export Montelukast to its top destination countries
Brazil — ANVISA
Approval Process
Generic registration under RDC 200/2017. ANVISA GMP inspection of Indian facility mandatory before approval.
Timeline: 12–24 months
GMP & Export Requirements
ANVISA GMP certificate (CBPF) for each manufacturing site; on-site inspection by ANVISA
Certificate of Pharmaceutical Product from CDSCO; Import Authorization via SISCOMEX
Note: ANVISA maintains active Indian pharma facility inspection program. Inspection backlog can extend timelines.
Canada — HC
Approval Process
ANDS (Abbreviated New Drug Submission) referencing Canadian Reference Product. Comparative bioavailability study required.
Timeline: 12–18 months
GMP & Export Requirements
Health Canada GMP (GUI-0001); Drug Establishment Licence (DEL) inspection
Drug Identification Number (DIN) for each product; Certificate of Pharmaceutical Product from CDSCO
Note: Subject to Good Import Practices and annual C.01.014.6 review.
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 SUN Pharmaceutical Industries Limited Compare to Nearest Montelukast Exporters?
Exporters ranked immediately above and below #14 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 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 |
| 13 | SANDOZ PRIVATE LIMITED | $1.3M | 26 | 1 | $50.0K |
SUN Pharmaceutical Industries Limited ranks #14 among 510 Indian Montelukast exporters. Average shipment value of $17.5K compared to the market average of $144.3K. The closest competitors by value are HETERO LABS LIMITED and DR REDDYS LABORATORIES 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 SUN Pharmaceutical Industries Limited's Montelukast Exports
Sun Pharma's export operations, valued at $979.8 million, are significantly influenced by current geopolitical events. The ongoing Israel-Iran tensions have led to disruptions in the Red Sea shipping routes, a critical corridor for Indian pharmaceutical exports to Europe and North Africa. Major shipping lines have imposed 'Emergency Risk Surcharges,' increasing freight costs and extending transit times by 10–15 days. These delays pose risks to the integrity of time-sensitive and temperature-controlled pharmaceutical shipments. (pharmaceuticalcommerce.com)
In the United States, policy shifts towards domestic manufacturing and the imposition of tariffs on imported pharmaceuticals have created challenges for Indian exporters. Sun Pharma, which supplies a substantial portion of generics to the U.S. market, faces potential reductions in export volumes due to these protectionist measures. The company is exploring strategies such as establishing local partnerships and investing in U.S.-based manufacturing to mitigate these impacts. (odrindia.in)
The European Union's implementation of the Carbon Border Adjustment Mechanism (CBAM) introduces additional compliance requirements for exporters. Sun Pharma must adapt to these regulations to maintain its market presence in the EU, necessitating investments in sustainable manufacturing practices and comprehensive reporting mechanisms. (sgeexport.com)
SUN Pharmaceutical Industries Limited — Regulatory Compliance & Quality Standards
Compliance with international regulatory standards remains a critical focus for Sun Pharma. The company has encountered challenges with the U.S. FDA, including import alerts and non-compliance letters for certain facilities. Addressing these issues involves implementing corrective actions and awaiting reinspection to resume full operations. (business-standard.com)
Globally, the pharmaceutical industry faces increasing scrutiny regarding quality standards. Sun Pharma's commitment to adhering to Good Manufacturing Practices (GMP) and other regulatory requirements is essential to maintain its export licenses and market reputation. Continuous investment in quality control systems and compliance infrastructure is imperative to navigate the evolving regulatory landscape.
About SUN Pharmaceutical Industries Limited
SUN Pharmaceutical Industries Limited exports 118 products worth $979.8M. Beyond Montelukast, top products include Strip, Esomeprazole, Magnesium, Calcium, Omeprazole. View the complete SUN Pharmaceutical Industries 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: SUN Pharmaceutical Industries 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 111 individual customs records matching SUN Pharmaceutical Industries Limited exporting Montelukast, covering 89 formulations to 8 countries via 22 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 SUN Pharmaceutical Industries Limited
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SUN Pharmaceutical Industries Limited
Full Company Profile →
118 products · $979.8M total trade · 25 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.