India to Croatia: Amlodipine Export Trade Route
India has recorded 42 verified shipments of Amlodipine exported to Croatia, representing a combined trade value of $15.0M USD. This corridor is served by 4 active Indian exporters, with an average shipment value of $356.3K USD. The leading Indian exporter is IPCA LABORATORIES LIMITED, which accounts for 98% of total export value with 23 shipments worth $14.6M USD. On the buying side, NA is the largest importer in Croatia with $14.3M USD in purchases. The top 3 suppliers — IPCA LABORATORIES LIMITED, MACLEODS PHARMACEUTICALS LTD, IPCA LABORATORIES LIMITED — together control 99% of total trade value on this route. All data sourced from Indian Customs (DGFT) shipping bill records. Values reported in FOB USD.
Route Intelligence Overview
The India to Croatia Amlodipine corridor is one of India's established pharmaceutical export routes, with 42 shipments documented worth a combined $15.0M USD. The route is dominated by IPCA LABORATORIES LIMITED, which alone accounts for roughly 98% of all export value, reflecting the consolidated nature of India's amlodipine manufacturing sector.
Across 4 active suppliers, the average shipment value stands at $356.3K USD — a figure that reflects both bulk commercial orders from large pharmaceutical companies and smaller specialty shipments. Sea freight dominates at 72% of all shipments, consistent with amlodipine's non-urgent bulk-order profile.
Shipment activity peaks during July–September, with an average transit time of 16 days port-to-port. The route has recorded an annual growth rate of 32.1%, placing it at rank #20 among India's top amlodipine export destinations globally.
On the import side, key buyers of Indian amlodipine in Croatia include NA, BELUPO PHARMACEUTICAL AND COSMETICS, Pharma S and 5 others. NA is the single largest importer with 8 shipments valued at $14.3M USD.
Route Characteristics
- Average transit16 days
- Peak seasonQ3
- Primary modeSea freight
- Top portNHAVA SHEVA SEA (INNSA1)
Market Position
- Global rank#20
- Annual growth+32.1%
- Demand growth+28.6%
- Regulatory ease74/100
Top 10 Indian Amlodipine Exporters to Croatia
Showing top 10 of 4 Indian suppliers exporting Amlodipine to Croatia, ranked by total trade value (USD)
| Rank | Supplier (Indian Exporter) | Shipments | Total Value (USD) | Market Share |
|---|---|---|---|---|
| 1 | IPCA LABORATORIES LIMITED Avg $635.0K per shipment | 23 | $14.6M | 97.6% |
| 2 | MACLEODS PHARMACEUTICALS LTD Avg $22.8K per shipment | 8 | $182.2K | 1.2% |
| 3 | IPCA LABORATORIES LIMITED Avg $25.9K per shipment | 4 | $103.6K | 0.7% |
| 4 | MACLEODS PHARMACEUTICALS LIMITED Avg $10.7K per shipment | 7 | $74.9K | 0.5% |
This table shows the top 10 of 4 Indian companies exporting amlodipine to Croatia, ranked by total trade value. The listed exporters are: IPCA LABORATORIES LIMITED, MACLEODS PHARMACEUTICALS LTD, IPCA LABORATORIES LIMITED , MACLEODS PHARMACEUTICALS LIMITED. IPCA LABORATORIES LIMITED is the dominant supplier with 23 shipments worth $14.6M USD, giving it a 98% market share. The top 3 suppliers together account for 99% of the total trade value on this route.
Top 10 Amlodipine Importers in Croatia
Showing top 10 of 8 known buyers in Croatia receiving Amlodipine shipments from India, ranked by import value
On the receiving end of this trade route, the leading importers of Indian amlodipine in Croatia include NA, BELUPO PHARMACEUTICAL AND COSMETICS, Pharma S, Pharma S , PHARMA S, among 8 total buyers. The largest importer is NA, accounting for $14.3M USD across 8 shipments — representing 96% of all amlodipine imports from India on this route.
| Rank | Importer / Buyer | Shipments | Import Value (USD) | Market Share |
|---|---|---|---|---|
| 1 | NA | 8 | $14.3M | 95.5% |
| 2 | BELUPO PHARMACEUTICAL AND COSMETICS | 12 | $204.3K | 1.4% |
| 3 | Pharma S | 8 | $184.2K | 1.2% |
| 4 | Pharma S | 4 | $103.6K | 0.7% |
| 5 | PHARMA S | 5 | $87.5K | 0.6% |
| 6 | BELUPO PHARMACEUTICAL AND COSMETIC | 2 | $37.1K | 0.2% |
| 7 | PHARMA SINDUSTRIJSKA CESTA | 2 | $36.5K | 0.2% |
| 8 | BELUPO PHARMACEUTICAL AND | 1 | $15.7K | 0.1% |
Top 10 Amlodipine Formulations Imported by Croatia
Showing top 10 of 42 product formulations shipped on the India to Croatia Amlodipine route, ranked by trade value
Croatia imports a wide range of amlodipine formulations from India, spanning tablets, capsules, suspensions, and combination drugs. The top formulation — AMLODIPINE 5MG TABLETS(AMLODIPINE MEDICAL VALLEY 5MG TABLETS(115896X10X10'S PACK= 11589600 TABLETS) — accounts for $7.7M USD across 1 shipments. There are 42 distinct product descriptions in the dataset, reflecting the variety of dosage forms and strengths imported.
| Rank | Product Formulation | Shipments | Trade Value (USD) | Market Share |
|---|---|---|---|---|
| 1 | AMLODIPINE 5MG TABLETS(AMLODIPINE MEDICAL VALLEY 5MG TABLETS(115896X10X10'S PACK= 11589600 TABLETS) | 1 | $7.7M | 51.6% |
| 2 | AMLODIPINE 5MG TABLETS(AMLODIPIN MEDICALVALLEY 5MG TABLETS(56075X1X105'S PACK=5887875 TABLETS) | 1 | $3.9M | 26.2% |
| 3 | AMLODIPINE 10MG TABLETS (AMLODIPIN MEDICAL VALLEY 10MG TABLETS)(28596X10X10'S PACK= 2859600 TABLETS) | 1 | $2.6M | 17.6% |
| 4 | Amlodipine 5mg Tablets(78360x10x10's Pac | 1 | $79.5K | 0.5% |
| 5 | Amlodipine 5mg Tablets(104340x8x14's Pac | 1 | $71.7K | 0.5% |
| 6 | Amlodipine 10mg Tablets51300x8x14's Pac | 1 | $48.9K | 0.3% |
| 7 | VAINAS HCT 5MG/160MG/12.5MG FTBL(AMLODIPINE/VALSARTAN / HYDROCHLOROTHIAZIDE TABLETS 5/160/12.5MG)PACK Size : 3X10 | 1 | $42.2K | 0.3% |
| 8 | Amlodipine 5mg Tablets(39272x10x10's Pac | 1 | $39.8K | 0.3% |
| 9 | Amlodipine 10mg Tablets(34520x8x14's Pac | 1 | $39.2K | 0.3% |
| 10 | Amlodipine 5mg Tablets52380x8x14's Pack=5866560 Tablets | 1 | $36.5K | 0.2% |
Showing top 10 of 42 Amlodipine formulations imported by Croatia on this route.
Shipping & Logistics Analysis
Freight mode split and port-of-origin breakdown
Freight Mode Distribution
Sea freight dominates at 72%, typical for bulk pharmaceutical shipments.
Top Ports of Origin
NHAVA SHEVA SEA (INNSA1) handles the highest volume with 12 shipments. Transit time averages 16 days by sea.
Market Dynamics
India's amlodipine exports to Croatia are driven primarily by a handful of large-scale manufacturers. IPCA LABORATORIES LIMITED with 23 shipments leads the pack, a pattern common in generic pharmaceutical corridors where manufacturing scale creates significant cost advantages. The presence of 4 active exporters signals a competitive but concentrated market — buyers in Croatia benefit from supplier diversity while the top tier handles the majority of volume.
The top 3 suppliers — IPCA LABORATORIES LIMITED, MACLEODS PHARMACEUTICALS LTD, IPCA LABORATORIES LIMITED — together account for 99% of total trade value on this route. The average shipment value of $356.3K USD reflects primarily bulk commercial orders from large pharmaceutical distributors.
Beyond the primary product category, shipments on this route include closely related formulations such as amlodipine 5mg tablets(amlodipin medicalvalley 5mg tablets(56075x1x105's pack=5887875 tablets) and amlodipine 10mg tablets (amlodipin medical valley 10mg tablets)(28596x10x10's pack= 2859600 tablets), suggesting that buyers in Croatia tend to consolidate orders across related product lines from the same Indian supplier.
On the buying side, NA is the largest importer with 8 shipments worth $14.3M USD — representing 96% of all amlodipine imports from India on this route. A total of 8 buyers are active on this corridor.
Route Statistics
- Trade Volume
- $15.0M
- Avg. Shipment
- $356.3K
- Suppliers
- 4
- Buyers
- 8
- Transit (Sea)
- ~16 days
- Annual Growth
- +32.1%
Related Analysis
Reverse Direction
Croatia → India — Amlodipine (Import)Other Amlodipine Routes
Unlock the Full India to Croatia Amlodipine Dataset
TransData Nexus provides verified shipment-level records, supplier contact details, HS code breakdowns, real-time pricing benchmarks, and regulatory compliance guides for 42 shipments on this route.
Live Corridor Intelligence
India → Croatia trade corridor intelligence
1Live Corridor Intelligence
As of March 2026, the India-Croatia pharmaceutical trade corridor is experiencing significant disruptions due to escalating tensions in the Middle East. Heightened security risks in the Strait of Hormuz and the Red Sea–Suez Canal corridor have led major shipping lines to suspend or restrict transits, resulting in vessels being rerouted around Africa's Cape of Good Hope. This diversion has extended transit times by 10–20 days and increased freight rates by 40–50% on key India–Europe routes.
Additionally, war-risk insurance premiums have surged, further elevating shipping costs. The combined effect of longer transit times and higher costs is particularly challenging for time-sensitive pharmaceutical exports, including finished formulations containing Amlodipine. These disruptions have also led to container and reefer imbalances, increasing the risk of cold-chain failures for temperature-sensitive products.
Currency fluctuations have added another layer of complexity. The Indian Rupee has experienced volatility against the Euro, impacting pricing strategies and profit margins for exporters. Trade policy changes, including new tariffs and port fees introduced by the United States and several trading partners, have added costs and uncertainty to global shipping.
Geopolitical & Sanctions Impact
India → Croatia trade corridor intelligence
1Geopolitical & Sanctions Impact
The India-Croatia pharmaceutical trade corridor is indirectly affected by global geopolitical tensions. The 12-day conflict between Israel and Iran in June 2025 led to extreme GPS and AIS signal jamming in the Strait of Hormuz, making safe navigation nearly impossible without military escorts. This conflict triggered an immediate surge in war-risk insurance premiums, adding approximately $10 per barrel to fuel costs, which directly translated into higher freight rates for bulk carriers.
While there are no direct sanctions between India and Croatia, the broader geopolitical landscape, including conflicts in the Middle East and Ukraine, has led to increased insurance premiums and freight rates. These factors contribute to the overall cost and complexity of shipping pharmaceutical products from India to Croatia.
Trade Agreement & Policy Analysis
India → Croatia trade corridor intelligence
1Trade Agreement & Policy Analysis
On January 27, 2026, India and the European Union concluded a comprehensive Free Trade Agreement (FTA) after nearly two decades of negotiations. This agreement aims to reduce or eliminate trade barriers, including customs duties and non-tariff measures, thereby facilitating smoother trade between India and EU member states, including Croatia.
The FTA covers trade in goods and services, intellectual property rights, investment, government procurement, and competition policy. It is expected to enhance market access for Indian pharmaceutical products in Croatia by reducing tariffs and streamlining regulatory processes. However, the agreement's full implementation is contingent upon approval by the Council of the European Union, consent of the European Parliament, and completion of approval by the Union Council of Ministers in India.
In the broader context, the World Trade Organization's Trade Facilitation Agreement (TFA) continues to play a role in expediting the movement, release, and clearance of goods, including pharmaceuticals. The TFA allows developing and least-developed country members to determine their own implementation schedules and seek technical assistance and capacity-building support.
Landed Cost Breakdown
India → Croatia trade corridor intelligence
1Landed Cost Breakdown
Estimating the landed cost for Amlodipine formulations shipped from India to Croatia involves several components:
1. FOB Price (Free on Board): The price of the goods at the Indian port before shipping. For Amlodipine formulations, this varies based on manufacturer and order size but typically ranges from $0.10 to $0.50 per tablet.
2. Sea Freight Cost: Due to current disruptions, freight rates have increased by 40–50%. Assuming a standard 20-foot container holds approximately 10 million tablets, and the pre-disruption freight cost was $2,000 per container, the current cost would be approximately $2,800–$3,000 per container.
3. Insurance: War-risk insurance premiums have surged, adding approximately $4,000–$8,000 per shipment.
4. Customs Duty: Under the new India-EU FTA, customs duties on pharmaceutical products are expected to be reduced or eliminated. However, until full implementation, existing duties apply, typically around 5–10% of the CIF (Cost, Insurance, and Freight) value.
5. Clearance Charges: These include port handling, documentation, and customs clearance fees, averaging $500–$1,000 per container.
6. VAT/GST: Croatia applies a Value Added Tax (VAT) of 25% on imported goods, calculated on the CIF value plus customs duty.
7. Local Distribution: Costs associated with warehousing, transportation, and distribution within Croatia, estimated at $0.05–$0.10 per tablet.
Per-Unit Cost Estimate:
- FOB Price: $0.10–$0.50 per tablet
- Sea Freight: $0.00028–$0.00030 per tablet
- Insurance: $0.0004–$0.0008 per tablet
- Customs Duty: $0.005–$0.05 per tablet
- Clearance Charges: $0.00005–$0.0001 per tablet
- VAT: $0.028–$0.14 per tablet
- Local Distribution: $0.05–$0.10 per tablet
Total Landed Cost per Tablet: Approximately $0.19–$0.79
These estimates are subject to fluctuations in freight rates, insurance premiums, and currency exchange rates. Exporters should monitor these variables closely to maintain competitive pricing and profitability.
Croatia Pharmaceutical Import Regulations
EMA registration, GMP, and compliance requirements for Indian exporters
1EMA Registration & Import Requirements
To import Amlodipine formulations into Croatia, the following approvals and registrations are necessary:
- Marketing Authorization: A valid marketing authorization issued by HALMED is mandatory. The application must be submitted in the Common Technical Document (CTD) or electronic CTD (eCTD) format, encompassing comprehensive data on quality, safety, and efficacy.
- Manufacturing and Import Authorization: Entities involved in the manufacture or import of medicinal products must possess appropriate authorizations. These authorizations are contingent upon compliance with Good Manufacturing Practice (GMP) standards.
- GMP Compliance: Manufacturing facilities, including those in India, must undergo GMP inspections to ensure adherence to EU standards. The frequency of these inspections is determined based on a risk-based approach.
- Batch Certification: Each batch imported into the European Economic Area (EEA) must be certified by a Qualified Person (QP) within the EEA, confirming compliance with GMP and the marketing authorization.
Timelines for approval can vary; however, GMP certificates are typically issued within 30 calendar days, extendable to 60 days if a new inspection is required. Product registration fees are subject to HALMED's current fee schedule.
2Quality & GMP Standards for Indian Exporters
Indian manufacturers exporting Amlodipine formulations to Croatia must comply with the following GMP standards:
- EU GMP Compliance: Manufacturers must adhere to EU GMP guidelines, ensuring consistent product quality and safety.
- GMP Certification: Facilities must obtain GMP certification from HALMED or another recognized EU competent authority. For instance, on July 18, 2025, STELLAPHARM J.V. Co., Ltd. achieved EU GMP certification issued by HALMED.
- EudraGMDP Database Listing: Certified manufacturers are listed in the EudraGMDP database, facilitating verification of compliance.
Recent inspections have identified deficiencies in some Indian facilities. For example, in August 2016, the German authority issued a GMP Non-Compliance Statement for an Indian API manufacturer due to significant deficiencies. Such findings underscore the importance of maintaining stringent quality standards.
3Recent Regulatory Developments (2024-2026)
Several regulatory changes between 2024 and 2026 have impacted Indian pharmaceutical exports to Croatia:
- Mutual Recognition Agreements (MRAs): As of August 7, 2024, the EU and the United States have implemented an MRA recognizing each other's GMP inspections for human medicines, streamlining regulatory processes.
- Falsified Medicines Directive (FMD): The FMD introduced new requirements for Qualified Person (QP) declarations, emphasizing the verification of active pharmaceutical ingredient (API) pedigrees and impacting GMP standards for intermediates and starting materials.
These developments necessitate that Indian exporters remain vigilant and adapt to evolving regulatory landscapes to ensure continued market access in Croatia.
Croatia Amlodipine Market Context & Tariffs
Market size, import duties, and competitive landscape · MFN tariff: 0.0%
1Croatia Amlodipine Market Size & Demand
Amlodipine, a calcium channel blocker, is widely prescribed in Croatia for managing hypertension and angina. The country's aging population and increasing prevalence of cardiovascular diseases have led to a steady demand for antihypertensive medications. In 2024, Croatia's healthcare expenditure was approximately €4.5 billion, with a significant portion allocated to cardiovascular treatments. While domestic pharmaceutical production exists, Croatia relies on imports to meet the full demand for amlodipine formulations.
2Import Tariff & Duty Structure
Croatia, as an EU member state, applies a Most-Favored-Nation (MFN) import duty rate of 0.0% on pharmaceutical products classified under HS code 30049072, which includes amlodipine formulations. This duty-free status facilitates the importation of these medications. Additionally, Croatia imposes a Value-Added Tax (VAT) on pharmaceutical products; however, specific VAT rates for pharmaceuticals are not detailed in the available data. There are no Free Trade Agreements (FTAs) between India and Croatia that specifically affect pharmaceutical tariffs, nor are there any anti-dumping duties imposed on amlodipine imports from India.
3Competitive Landscape
India is a significant supplier of amlodipine formulations to Croatia, with IPCA Laboratories Limited leading exports valued at $14.6 million. Other notable Indian exporters include Macleods Pharmaceuticals Ltd. Croatia also imports amlodipine formulations from European Union manufacturers, benefiting from intra-EU trade agreements and proximity. While specific data on India's share of Croatia's total amlodipine imports and comparative pricing with competitors like China and EU manufacturers is not available, India's competitive pricing and established pharmaceutical industry position it as a key player in Croatia's amlodipine market.
Supplier Due Diligence Guide — Amlodipine from India
Pre-qualification checklist, document requirements, red flags, and audit guidance for Croatia buyers
1Pre-Qualification Checklist for Croatia Buyers
Before engaging with Indian manufacturers for Amlodipine formulations, Croatian buyers should adhere to the following pre-qualification steps:
1. Verify EMA Registration:
2. Assess GMP Certification Validity:
3. Review Drug Master File (DMF):
4. Evaluate Quality Management Systems:
5. Check for Additional Certifications:
6. Conduct a Risk Assessment:
7. Plan for On-Site Audit:
2Key Documents to Request from Indian Suppliers
When sourcing Amlodipine formulations from Indian manufacturers, Croatian buyers should request the following documents:
1. Certificate of Analysis (CoA):
2. Certificate of Origin (CoO):
3. GMP Certificate:
4. Stability Data:
5. Batch Manufacturing Records:
6. Drug Master File (DMF):
7. Free Sale Certificate:
8. Insurance Certificates:
3Red Flags & Warning Signs
When evaluating Indian suppliers for Amlodipine formulations, be vigilant for the following warning signs:
1. Regulatory Non-Compliance:
2. Unrealistically Low Pricing:
3. Lack of Stability Data:
4. Absence of EU Market Experience:
5. Resistance to Audits:
4Factory Audit & Ongoing Monitoring
To ensure continuous compliance and product quality, implement the following audit and monitoring procedures:
1. Pre-Audit Desktop Review:
2. On-Site Inspection Focus Areas:
3. Post-Audit Corrective Actions:
4. Annual Re-Qualification Process:
5. Remote Monitoring Options:
Cost Estimates and Timeline:
- Audit Visits to India:
- Cost: Approximately $10,000 to $15,000 USD per audit, covering travel, accommodation, and professional fees.
- Timeline: Plan for a 4 to 6-week lead time to schedule and conduct the audit, including preparation and reporting.
By adhering to these guidelines, Croatian buyers can ensure the selection of reliable Indian suppliers for Amlodipine formulations, maintaining high standards of quality and regulatory compliance.
Frequently Asked Questions — India to Croatia Amlodipine Trade
Answers based on Indian Customs (DGFT) shipment records compiled by TransData Nexus
Q Which Indian companies export Amlodipine to Croatia?
The leading Indian exporters of Amlodipine to Croatia are IPCA LABORATORIES LIMITED, MACLEODS PHARMACEUTICALS LTD, IPCA LABORATORIES LIMITED . IPCA LABORATORIES LIMITED holds the largest market share at approximately 98% of total trade value on this route.
Q What is the total value of Amlodipine exports from India to Croatia?
India exports Amlodipine to Croatia worth approximately $15.0M USD across 42 recorded shipments. The average value per shipment is $356.3K USD.
Q Which ports does India use to ship Amlodipine to Croatia?
The most active port of origin is NHAVA SHEVA SEA (INNSA1) with 12 shipments. Indian exporters primarily use sea freight for this route, with 72% of shipments going by sea and 20% by air.
Q How long does shipping take from India to Croatia for Amlodipine?
The average transit time for Amlodipine shipments from India to Croatia is approximately 16 days. Sea freight typically takes longer, while air freight can reduce this significantly for urgent orders. Peak shipping activity is observed during July–September.
Q Is the India to Croatia Amlodipine trade route growing?
Yes — this trade corridor has seen an annual growth rate of approximately 32.1% with demand growth tracking at 28.6%. The route is ranked #20 among India's top Amlodipine export destinations globally.
Q How many suppliers are active on the India to Croatia Amlodipine route?
There are currently 4 active Indian suppliers exporting Amlodipine to Croatia. The market is moderately concentrated with IPCA LABORATORIES LIMITED accounting for 98% of total shipment value.
Q Who are the main importers of Amlodipine from India in Croatia?
The leading importers of Indian Amlodipine in Croatia include NA, BELUPO PHARMACEUTICAL AND COSMETICS, Pharma S, Pharma S , PHARMA S. NA is the largest buyer with 8 shipments worth $14.3M USD.
Official References & Regulatory Resources
- India Trade Statistics (DGFT)
- Invest India — Pharma Sector
- WCO HS Nomenclature
- Ministry of Commerce — Pharma Exports
- Pharmexcil
Data sourced from Indian Customs (DGFT) records. Verify regulatory and trade status with the 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.Route Identification: India to Croatia export trade corridor identified from Indian Customs (DGFT) records for Amlodipine.
- 2.Supplier/Buyer Matching: 4 Indian exporters and 8 importers in Croatia matched using name normalization.
- 3.Value Aggregation: Total export value aggregated from 42 verified shipping bill records. Values are FOB in USD.
- 4.Market Share Analysis: Each supplier and buyer contribution calculated as a percentage of total route value. Statistical normalization applied to ensure accurate representation across varying shipment sizes.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
42 Verified Shipments
4 Indian exporters tracked
Expert-Reviewed
By pharmaceutical trade specialists