Ajanta Pharma Limited — Montelukast Exporter Profile
Indian Pharmaceutical Exporter · #3 for Montelukast · $6.4M export value · DGFT Verified
Ajanta Pharma Limited is the #3 Indian exporter of Montelukast with $6.4M in export value and 128 verified shipments. Ajanta Pharma Limited holds a 3.8% market share in Montelukast exports across 5 countries. The company exports 37 pharmaceutical products worth $116.1M across 17 therapeutic categories.
Ajanta Pharma Limited — Montelukast Export Profile: Buyers & Destinations
Where Does Ajanta Pharma Limited Export Montelukast?
| Country | Value | Shipments | Share |
|---|---|---|---|
| PHILIPPINES | $1.6M | 36 | 40.6% |
| IRAQ | $1.4M | 59 | 35.6% |
| UNITED STATES | $807.4K | 24 | 21.0% |
| YEMEN, DEMOCRATIC | $64.1K | 6 | 1.7% |
| BOLIVIA | $43.3K | 3 | 1.1% |
Ajanta Pharma Limited exports Montelukast to 5 countries. The largest destination is PHILIPPINES accounting for 40.6% of Ajanta Pharma Limited's Montelukast shipments, followed by IRAQ (35.6%) and UNITED STATES (21.0%). These destinations reflect Ajanta Pharma Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Montelukast from Ajanta Pharma Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| AJANTA PHARMA PHILIPPINES INC | PHILIPPINES | $657.0K | 15 |
| AJANTA PHARMA USA INC. C/O RXCROSSR | UNITED STATES | $606.4K | 19 |
| THE CATHAY DRUG CO. INC | PHILIPPINES | $550.0K | 11 |
| KAWKAB SCIENTIFIC BUREAU* | IRAQ | $477.0K | 23 |
| SHAMS AL-THURAYA CO FOR GENERAL TRA | IRAQ | $250.5K | 7 |
| THE CATHAY DRUG CO. INC. | PHILIPPINES | $201.7K | 7 |
| SHAMS AL-THURAYA CO | IRAQ | $200.0K | 4 |
| HAWKARY PHARMACEUITCAL CO.* | IRAQ | $175.4K | 12 |
| THE CATHAY DRUG CO INC | PHILIPPINES | $150.0K | 3 |
| KAWKAB SCIENTIFIC BUREAU | IRAQ | $143.7K | 7 |
Ajanta Pharma Limited supplies Montelukast to 19 buyers globally. The largest buyer is AJANTA PHARMA PHILIPPINES INC (PHILIPPINES), followed by AJANTA PHARMA USA INC. C/O RXCROSSR (UNITED STATES) and THE CATHAY DRUG CO. INC (PHILIPPINES). 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 Ajanta Pharma Limited Contribute?
India exported $73.6M worth of Montelukast through 6,431 shipments from 510 suppliers to 138 countries, serving 1,324 buyers globally. Ajanta Pharma Limited contributes $6.4M to this total, accounting for 3.8% of India's Montelukast exports. Ajanta Pharma Limited ships Montelukast to 5 countries through 19 buyers.
What Is the Average Shipment Value for Ajanta Pharma Limited's Montelukast Exports?
Ajanta Pharma Limited's average Montelukast shipment value is $50.0K per consignment, based on 128 shipments totaling $6.4M. The largest destination is PHILIPPINES (40.6% of Ajanta Pharma Limited's Montelukast exports).
How Does Ajanta Pharma Limited Compare to Other Indian Montelukast Exporters?
Ajanta Pharma Limited ranks #3 among 510 Indian Montelukast exporters with a 3.8% market share. The top 3 exporters are UNICHEM LABORATORIES LIMITED ($13.1M), MACLEODS PHARMACEUTICALS LTD ($11.6M), DR.REDDY'S LABORATORIES LTD ($9.4M). Ajanta Pharma Limited processed 128 shipments to 5 destination countries.
What Montelukast Formulations Does Ajanta Pharma Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| MUBACT L 10/5 TABLETS[23760 X 3 X 10 = 712800 TABLETS][MONTELUKAST 10 MG PLUS LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG TABS]CNOS | $200.5K | 6 |
| ZYKAST TAB 10/5MG[123549PAC X 3 X 10 = 3706470][MONTELUKAST 10 MG PLUS LEVOCETIRIZINE 5 MG TABLETS]NOS | $150.0K | 3 |
| MUBACT L 10/5 TABLETS[63036PACKX3X10 = 1891080TABS]MONTELUKAST 10 MG PLUS LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG AS PER INV | $150.0K | 3 |
| ZYKAST TAB 10/5MG[187104 X 3 X 10 = 5613120][MONTELUKAST 10 MG PLUS LEVOCETIRIZINE 5 MG TABLETS]CONT:AS PER INVOICE | $150.0K | 3 |
| MONTELUKAST SODIUM ORAL GRANULES 4MG[744 | $117.3K | 4 |
| MONTELUKAST SODIUM ORAL GRANULES 4MG[796 | $115.2K | 4 |
| MONTELUKAST SODIUM ORAL GRANULES 4MG [8, | $111.0K | 4 |
| ZYKAST 10 5 MG TABLETS 61584 X 3 X 10 1847520 TABS MONTELUKAST 10 MG PLUS LEVOCETIRIZINE 5 MG TABS CONT AS PER INVOI | $100.0K | 2 |
| ZYKIDS FORTE TAB 5/5MG[25680PACKX3X10=770400 TABS]EACH CHEWABLE TAB CONT:MONTELUKAST SODIUM USP 5.2 MG AS PER INV | $90.5K | 3 |
| MUBACT 4 [MONTELUKAST SODIUM ORAL GRANUL | $87.7K | 4 |
Ajanta Pharma Limited exports 90 distinct Montelukast formulations including tablets, capsules, syrups, and combination drugs. The top formulation is MUBACT L 10/5 TABLETS[23760 X 3 X 10 = 712800 TABLETS][MONTE with 6 shipments worth $200.5K.
Regulatory Requirements: Exporting Montelukast to Key Markets
What Ajanta Pharma 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.
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 Ajanta Pharma Limited Compare to Nearest Montelukast Exporters?
Exporters ranked immediately above and below #3 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 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 |
| 5 | CIPLA LIMITED | $4.6M | 92 | 5 | $50.0K |
Ajanta Pharma Limited ranks #3 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 MACLEODS PHARMACEUTICALS LTD and DR.REDDY'S LABORATORIES 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% |
Geopolitical & Trade Policy Impact on Ajanta Pharma Limited's Montelukast Exports
Ajanta Pharma's export operations are intricately linked to global trade routes, making them susceptible to geopolitical tensions. The ongoing Israel-Iran conflict has disrupted shipping lanes in the Red Sea, leading to increased freight costs and extended delivery timelines. Such disruptions pose challenges for Indian pharmaceutical exporters like Ajanta, necessitating adaptive logistics strategies to maintain supply chain integrity. (pharmaceuticalcommerce.com)
Conversely, the US-China trade tensions have opened avenues for Indian pharmaceutical companies to strengthen their foothold in the American market. India's pharmaceutical exports to the US surged by 74% in March 2025, indicating a shift in sourcing preferences. Ajanta Pharma can leverage this trend by emphasizing its compliance with stringent US regulatory standards and offering competitive pricing. (business-standard.com)
In the European Union, adherence to the Falsified Medicines Directive (FMD) is paramount. Indian exporters, including Ajanta, must ensure robust serialization and traceability measures to comply with these regulations. Non-compliance could result in restricted market access, underscoring the importance of investing in advanced tracking systems and quality assurance protocols.
Ajanta Pharma Limited — Regulatory Compliance & Quality Standards
The global pharmaceutical industry is witnessing heightened regulatory scrutiny, with agencies like the US FDA, WHO, and EU GMP setting stringent compliance benchmarks. India has made significant strides in this arena, surpassing the US in the number of FDA-registered generic manufacturing sites, boasting 752 FDA-approved facilities as of 2024. (business-standard.com) Ajanta Pharma's commitment to quality is evident in its adherence to these international standards, facilitating smoother market entry and bolstering its reputation among global stakeholders.
About Ajanta Pharma Limited
Ajanta Pharma Limited exports 37 products worth $116.1M. Beyond Montelukast, top products include Artemether, Amlodipine, Clopidogrel, Rosuvastatin, Valsartan. View the complete Ajanta Pharma 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: Ajanta Pharma 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 128 individual customs records matching Ajanta Pharma Limited exporting Montelukast, covering 90 formulations to 5 countries via 19 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 Ajanta Pharma Limited
Access shipment-level details, pricing data, buyer connections, and competitive analysis for Ajanta Pharma Limited's Montelukast exports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
Ajanta Pharma Limited
Full Company Profile →
37 products · $116.1M total trade · 17 categories
Montelukast Stats
Company Overview
Top Products by Ajanta Pharma Limited
Related Analysis
Need Detailed Export Data?
Access shipment-level records, pricing trends, and buyer contacts for Ajanta Pharma Limited.
Request DemoView Pricing →Data Source
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.