Unichem Laboratories Limited — Montelukast Exporter Profile
Indian Pharmaceutical Exporter · #2 for Montelukast · $13.1M export value · DGFT Verified
Unichem Laboratories Limited is the #2 Indian exporter of Montelukast with $13.1M in export value and 262 verified shipments. Unichem Laboratories Limited holds a 7.8% market share in Montelukast exports across 3 countries. The company exports 19 pharmaceutical products worth $241.0M across 9 therapeutic categories.
Unichem Laboratories Limited — Montelukast Export Profile: Buyers & Destinations
Where Does Unichem Laboratories Limited Export Montelukast?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $9.3M | 246 | 99.3% |
| MYANMAR | $47.0K | 10 | 0.5% |
| TANZANIA | $22.2K | 6 | 0.2% |
Unichem Laboratories Limited exports Montelukast to 3 countries. The largest destination is UNITED STATES accounting for 99.3% of Unichem Laboratories Limited's Montelukast shipments, followed by MYANMAR (0.5%) and TANZANIA (0.2%). These destinations reflect Unichem Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Montelukast from Unichem Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| UNICHEM PHARMACEUTICALS (USA) INC. | UNITED STATES | $4.2M | 112 |
| UNICHEM PHARMACEUTICALS USA INC | UNITED STATES | $2.1M | 50 |
| UNICHEM PHARMACEUTICALS (USA), INC | UNITED STATES | $1.7M | 45 |
| UNICHEM PHARMACEUTICALS (USA) INC | UNITED STATES | $1.0M | 29 |
| UNICHEM PHARMACEUTICALS (USA) INC.. | UNITED STATES | $132.3K | 3 |
| UNICHEM PHARMACEUTICALS (USA)INC | UNITED STATES | $107.1K | 3 |
| UNICHEM PHARMACEUTICALS USA IN | UNITED STATES | $50.0K | 1 |
| UNICHEM PHARMACEUTICALS USA INC | UNITED STATES | $34.1K | 3 |
| ASTRA PHARMA (T) LTD | TANZANIA | $22.2K | 6 |
| LWIN AND MYINT TRADING CO.LTD. | MYANMAR | $20.1K | 1 |
Unichem Laboratories Limited supplies Montelukast to 13 buyers globally. The largest buyer is UNICHEM PHARMACEUTICALS (USA) INC. (UNITED STATES), followed by UNICHEM PHARMACEUTICALS USA INC (UNITED STATES) and UNICHEM PHARMACEUTICALS (USA), INC (UNITED STATES). 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 Unichem 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. Unichem Laboratories Limited contributes $13.1M to this total, accounting for 7.8% of India's Montelukast exports. Unichem Laboratories Limited ships Montelukast to 3 countries through 13 buyers.
What Is the Average Shipment Value for Unichem Laboratories Limited's Montelukast Exports?
Unichem Laboratories Limited's average Montelukast shipment value is $50.0K per consignment, based on 262 shipments totaling $13.1M. The largest destination is UNITED STATES (99.3% of Unichem Laboratories Limited's Montelukast exports).
How Does Unichem Laboratories Limited Compare to Other Indian Montelukast Exporters?
Unichem Laboratories Limited ranks #2 among 510 Indian Montelukast exporters with a 7.8% market share. The top 3 exporters are UNICHEM LABORATORIES LIMITED ($13.1M), MACLEODS PHARMACEUTICALS LTD ($11.6M), DR.REDDY'S LABORATORIES LTD ($9.4M). Unichem Laboratories Limited processed 262 shipments to 3 destination countries.
What Montelukast Formulations Does Unichem Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| FINISHED FORMULATION MONTELUKAST SODIUM | $908.3K | 21 |
| HARMLESS MEDICINES : MONTELUKAST SODIUM 10MGTABLETS 90T USPMontelukast Sodium Tablets 10mgNDC Code: 293002201 | $819.2K | 23 |
| HARMLESS MEDICINES : MONTELUKAST SODIUM 10MGTABLETS 1000T USPMontelukast Sodium Tablets 10mgNDC Code: 2930022 | $586.4K | 15 |
| FINISHED FORMULATION-MONTELUKAST SODIUM | $547.6K | 11 |
| FINISHED FORMULATION MONTELUKAST SODIUM 10MG TABLETS 90T USP Montelukast Sodium Tablets 10mg NDC Code: 2930022019 BOTTLE | $476.4K | 12 |
| MONTELUKAST SODIUM 10MG TABLETS 90T Mont | $350.0K | 7 |
| FINISHED FORMULATION - MONTELUKAST SODIU | $350.0K | 7 |
| MONTELUKAST SODIUM 10MG TABLETS 90T (MON | $250.0K | 5 |
| FINISHED FORMULATION: MONTELUKAST SODIUM | $247.0K | 5 |
| MONTELUKAST SODIUM 10MG TABLETS 1000T ( | $200.0K | 4 |
Unichem Laboratories Limited exports 93 distinct Montelukast formulations including tablets, capsules, syrups, and combination drugs. The top formulation is FINISHED FORMULATION MONTELUKAST SODIUM with 21 shipments worth $908.3K.
Regulatory Requirements: Exporting Montelukast to Key Markets
What Unichem 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.
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 Unichem Laboratories Limited Compare to Nearest Montelukast Exporters?
Exporters ranked immediately above and below #2 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 |
Unichem Laboratories Limited ranks #2 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 Unichem Laboratories Limited's Montelukast Exports
Unichem's export operations are influenced by a complex geopolitical landscape. The ongoing Israel-Iran tensions have led to increased security risks in the Red Sea, prompting major shipping lines to implement 'Emergency Risk Surcharges' ranging from $250 to $500 per TEU. These additional costs directly impact Indian exporters like Unichem, potentially eroding profit margins or necessitating price adjustments. (sgeexport.com)
Conversely, the U.S.-China trade tensions have opened avenues for Indian pharmaceutical companies to capture market share in the U.S., as American importers seek alternative suppliers to mitigate risks associated with Chinese imports. This shift presents an opportunity for Unichem to expand its footprint in the lucrative U.S. market.
In the European Union, the implementation of the Carbon Border Adjustment Mechanism (CBAM) introduces new compliance requirements for exporters. The Directorate General of Foreign Trade (DGFT) in India has established a 'CBAM Facilitation Cell' to assist exporters in navigating these regulations. For Unichem, adherence to CBAM is crucial to maintain competitiveness in the EU market, necessitating investments in sustainable practices and transparent reporting. (sgeexport.com)
Unichem Laboratories Limited — Regulatory Compliance & Quality Standards
Compliance with international regulatory standards is paramount for Unichem's export success. In June 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of Unichem's Roha facility, resulting in three observations related to procedural changes, though none pertained to data integrity. The company promptly addressed these observations, demonstrating its commitment to maintaining stringent quality standards. (capitalmarket.com)
Additionally, Unichem's proactive approach to regulatory compliance is evident in its adherence to the Securities and Exchange Board of India (SEBI) regulations, as confirmed by its compliance with share dematerialization requirements for Q1 FY26. (moneycontrol.com) Such diligence enhances the company's credibility and facilitates smoother operations in international markets.
About Unichem Laboratories Limited
Unichem Laboratories Limited exports 19 products worth $241.0M. Beyond Montelukast, top products include Amlodipine, Iron, Allopurinol, Hydrochlorothiazide, Bisoprolol. View the complete Unichem 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: Unichem 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 262 individual customs records matching Unichem Laboratories Limited exporting Montelukast, covering 93 formulations to 3 countries via 13 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 Unichem Laboratories Limited
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Unichem Laboratories Limited
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19 products · $241.0M total trade · 9 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.