Macleods Pharmaceuticals Ltd — Amlodipine Exporter Profile
Indian Pharmaceutical Exporter · #6 for Amlodipine · $17.5M export value · DGFT Verified
Macleods Pharmaceuticals Ltd is the #6 Indian exporter of Amlodipine with $17.5M in export value and 350 verified shipments. Macleods Pharmaceuticals Ltd holds a 2.3% market share in Amlodipine exports across 36 countries.
Macleods Pharmaceuticals Ltd — Amlodipine Export Profile: Buyers & Destinations
Where Does Macleods Pharmaceuticals Ltd Export Amlodipine?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.7M | 118 | 15.3% |
| FRANCE | $1.4M | 44 | 12.7% |
| GERMANY | $1.2M | 31 | 10.5% |
| AUSTRALIA | $1.1M | 50 | 9.4% |
| GREECE | $845.1K | 28 | 7.5% |
| JORDAN | $762.8K | 30 | 6.8% |
| MALTA | $513.3K | 30 | 4.5% |
| UNITED ARAB EMIRATES | $463.5K | 22 | 4.1% |
| GEORGIA | $284.3K | 9 | 2.5% |
| CROATIA | $257.0K | 15 | 2.3% |
Macleods Pharmaceuticals Ltd exports Amlodipine to 45 countries. The largest destination is UNITED STATES accounting for 15.3% of Macleods Pharmaceuticals Ltd's Amlodipine shipments, followed by FRANCE (12.7%) and GERMANY (10.5%). These destinations reflect Macleods Pharmaceuticals Ltd's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Amlodipine from Macleods Pharmaceuticals Ltd?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| PLANETPHARMA | FRANCE | $948.5K | 30 |
| MACLEODS PHARMA USA ,INC | UNITED STATES | $791.1K | 41 |
| HEUMANN PHARMA GMBH & CO. | MALTA | $752.5K | 36 |
| DEMO SA PHARMACEUTICAL INDUSTRY | GREECE | $642.4K | 23 |
| PHARMA INTERNATIONAL COMPANY | JORDAN | $526.9K | 23 |
| MACLEODS PHARMA USA INC | UNITED STATES | $456.9K | 28 |
| NEXTPHARMA LOGISTICS GMBH | GERMANY | $431.9K | 11 |
| PLANETPHARMA ZAC DU GRAND LAUNAY | FRANCE | $392.7K | 11 |
| APOTEX PTY LTD | AUSTRALIA | $366.6K | 15 |
| HEUMANN PHARMA GMBH AND CO. | GERMANY | $326.8K | 8 |
Macleods Pharmaceuticals Ltd supplies Amlodipine to 108 buyers globally. The largest buyer is PLANETPHARMA (FRANCE), followed by MACLEODS PHARMA USA ,INC (UNITED STATES) and HEUMANN PHARMA GMBH & CO. (MALTA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Amlodipine Export Value and How Much Does Macleods Pharmaceuticals Ltd Contribute?
India exported $311.2M worth of Amlodipine through 15,000 shipments from 599 suppliers to 159 countries, serving 1,862 buyers globally. Macleods Pharmaceuticals Ltd contributes $17.5M to this total, accounting for 2.3% of India's Amlodipine exports. Macleods Pharmaceuticals Ltd ships Amlodipine to 45 countries through 108 buyers.
What Is the Average Shipment Value for Macleods Pharmaceuticals Ltd's Amlodipine Exports?
Macleods Pharmaceuticals Ltd's average Amlodipine shipment value is $50.0K per consignment, based on 350 shipments totaling $17.5M. The largest destination is UNITED STATES (15.3% of Macleods Pharmaceuticals Ltd's Amlodipine exports).
How Does Macleods Pharmaceuticals Ltd Compare to Other Indian Amlodipine Exporters?
Macleods Pharmaceuticals Ltd ranks #6 among 599 Indian Amlodipine exporters with a 2.3% market share. The top 3 exporters are CIPLA LIMITED ($101.8M), ALKEM LABORATORIES LIMITED ($37.3M), UNICHEM LABORATORIES LIMITED ($34.5M). Macleods Pharmaceuticals Ltd processed 350 shipments to 36 destination countries.
What Amlodipine Formulations Does Macleods Pharmaceuticals Ltd Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| AMLODIPINE BESILATE TABLETS 5MG 10X10S | $281.5K | 7 |
| AMLODIPINE 10MG AND OLMESARTAN 40MG TABL | $224.3K | 11 |
| AMLODIPINE AND VALSARTAN HYDROCHLOROTHIAZIDE TABLETS 5/160MG(COVADIR 5 /160MG)(3X 10S TABS) | $175.7K | 9 |
| BIFEKT (AMLODIPINE 5MG AND LISINOPRIL 10MG TABS) 3X10S (139489 PAC)TBS | $134.3K | 3 |
| AMAPINE 10MG CPR B/10(AMLODIPINE BESILATE TABLETS 10 MG) AMAP100 1X10S (191870PAC)TBS | $123.5K | 3 |
| AMAPINE 10MG CPR B/30(AMLODIPINE BESILAT | $122.4K | 3 |
| AMLODIPINE AND VALSARTAN HYDROCHLOROTHIAZIDE TABLETS 10/320/25MG(COVADIR 10/320/25MG)(3 X 10S TABS) | $119.3K | 3 |
| AMLODIPINE BESILATE TABLETS 5MG | $102.9K | 3 |
| AMLODIPINE AND VALSARTAN HYDROCHLOROTHIAZIDE TABLETS 5/160MG(COVADIR 5 /160MG)(3 X 10S TABS) BATCH NO:BAL92310A MFG.DTNOS | $100.3K | 3 |
| DRUGS&PHA.HARMLESS MED.AMLODIPINE/VALSAR10MG/160MG 30T (FR),BN.BAM12304C,MFG.DT.JUN-23,EXP.DT.MAY-26,PACK S-3X10S | $100.0K | 2 |
Macleods Pharmaceuticals Ltd exports 500 distinct Amlodipine formulations including tablets, capsules, syrups, and combination drugs. The top formulation is AMLODIPINE BESILATE TABLETS 5MG 10X10S with 7 shipments worth $281.5K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Amlodipine to Key Markets
What Macleods Pharmaceuticals Ltd must comply with to export Amlodipine 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.
Germany — BfArM/EMA
Approval Process
Marketing Authorisation via Decentralized or Mutual Recognition Procedure under EU Directive 2001/83/EC. CTD Module 1–5 dossier required.
Timeline: 12–18 months via Decentralized Procedure
GMP & Export Requirements
EU GMP (EudraLex Vol. 4); GMP certificate from EU competent authority; WHO Prequalification accepted as supporting evidence
Certificate of Pharmaceutical Product (CPP) from CDSCO; Written Confirmation for API export per EU requirements; EU FMD serialization mandatory
Note: Indian manufacturers must hold EU GMP certificate. EU Falsified Medicines Directive (FMD) serialization and tamper-evident packaging mandatory.
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 Macleods Pharmaceuticals Ltd Compare to Nearest Amlodipine Exporters?
Exporters ranked immediately above and below #6 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 5 | IPCA LABORATORIES LIMITED | $21.9M | 438 | 14 | $50.0K |
| 3 | MYLAN LABORATORIES LIMITED | $19.4M | 387 | 11 | $50.0K |
| 6 | MACLEODS PHARMACEUTICALS LTD ★ | $17.5M | 350 | 36 | $50.0K |
| 7 | LUPIN LIMITED | $17.4M | 360 | 2 | $48.2K |
| 8 | MICRO LABS LIMITED | $16.0M | 628 | 32 | $25.4K |
Macleods Pharmaceuticals Ltd ranks #6 among 599 Indian Amlodipine exporters. Average shipment value of $50.0K compared to the market average of $519.5K. The closest competitors by value are IPCA LABORATORIES LIMITED and MYLAN LABORATORIES LIMITED.
Which Indian Ports Ship Amlodipine Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 2,082 | 13.9% |
| NHAVA SHEVA SEA (INNSA1) | 1,850 | 12.3% |
| JNPT/ NHAVA SHEVA SEA | 1,599 | 10.7% |
| SAHAR AIR CARGO ACC (INBOM4) | 1,229 | 8.2% |
| DELHI AIR | 802 | 5.3% |
| DELHI AIR CARGO ACC (INDEL4) | 748 | 5.0% |
| JNPT | 710 | 4.7% |
| Bombay Air | 417 | 2.8% |
Market Intelligence
Latest developments and market context
Detailed market intelligence for Amlodipine — 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: Amlodipine shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Macleods Pharmaceuticals 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 717 individual customs records matching Macleods Pharmaceuticals Ltd exporting Amlodipine, covering 500 formulations to 45 countries via 108 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 159+ countries, 1,862+ 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 Amlodipine. For current shipment-level data, contact TransData Nexus.