Cipla Limited — Amlodipine Exporter Profile
Indian Pharmaceutical Exporter · #1 for Amlodipine · $101.8M export value · DGFT Verified
Cipla Limited is the #1 Indian exporter of Amlodipine with $101.8M in export value and 2,036 verified shipments. Cipla Limited holds a 0.9% market share in Amlodipine exports across 15 countries. The company exports 98 pharmaceutical products worth $1.1B across 26 therapeutic categories.
Cipla Limited — Amlodipine Export Profile: Buyers & Destinations
Where Does Cipla Limited Export Amlodipine?
| Country | Value | Shipments | Share |
|---|---|---|---|
| GERMANY | $19.8M | 1,570 | 53.1% |
| UNITED STATES | $12.4M | 693 | 33.1% |
| SRI LANKA | $1.1M | 51 | 3.0% |
| OMAN | $743.7K | 22 | 2.0% |
| NEW ZEALAND | $688.3K | 34 | 1.8% |
| PANAMA | $598.4K | 47 | 1.6% |
| FRANCE | $445.4K | 56 | 1.2% |
| MADAGASCAR | $442.2K | 45 | 1.2% |
| YEMEN, DEMOCRATIC | $399.2K | 11 | 1.1% |
| SOUTH AFRICA | $281.0K | 13 | 0.8% |
Cipla Limited exports Amlodipine to 18 countries. The largest destination is GERMANY accounting for 53.1% of Cipla Limited's Amlodipine shipments, followed by UNITED STATES (33.1%) and SRI LANKA (3.0%). These destinations reflect Cipla Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Amlodipine from Cipla Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| B LOGISTIK GMBH | GERMANY | $19.4M | 1,540 |
| CIPLA USA INC UPS SUPPLY CHAIN SOLU | UNITED STATES | $7.5M | 471 |
| CIPLA USA INC UPS SUPPLY CHAIN SOL | UNITED STATES | $2.4M | 127 |
| PRIORITY HEALTHCARE DISTRIBUTION DB | UNITED STATES | $1.7M | 68 |
| BREATHEFREE LANKA PVT LTD | SRI LANKA | $898.6K | 41 |
| CAPITAL PHARMACY | OMAN | $743.7K | 22 |
| REX MEDICAL LTD, | NEW ZEALAND | $465.5K | 19 |
| AGENCIAS CELMAR, | PANAMA | $457.0K | 34 |
| BOEHRINGER INGELHEIM INTERNATIONAL | GERMANY | $452.9K | 30 |
| PRIORITY HEALTHCARE DISTRIBUTION D | UNITED STATES | $427.0K | 14 |
Cipla Limited supplies Amlodipine to 32 buyers globally. The largest buyer is B LOGISTIK GMBH (GERMANY), followed by CIPLA USA INC UPS SUPPLY CHAIN SOLU (UNITED STATES) and CIPLA USA INC UPS SUPPLY CHAIN SOL (UNITED STATES). 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 Cipla Limited Contribute?
India exported $311.2M worth of Amlodipine through 15,000 shipments from 599 suppliers to 159 countries, serving 1,862 buyers globally. Cipla Limited contributes $101.8M to this total, accounting for 0.9% of India's Amlodipine exports. Cipla Limited ships Amlodipine to 18 countries through 32 buyers.
What Is the Average Shipment Value for Cipla Limited's Amlodipine Exports?
Cipla Limited's average Amlodipine shipment value is $50.0K per consignment, based on 2,036 shipments totaling $101.8M. The largest destination is GERMANY (53.1% of Cipla Limited's Amlodipine exports).
How Does Cipla Limited Compare to Other Indian Amlodipine Exporters?
Cipla Limited ranks #1 among 599 Indian Amlodipine exporters with a 0.9% market share. The top 3 exporters are CIPLA LIMITED ($101.8M), ALKEM LABORATORIES LIMITED ($37.3M), UNICHEM LABORATORIES LIMITED ($34.5M). Cipla Limited processed 2,036 shipments to 15 destination countries.
What Amlodipine Formulations Does Cipla Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| TELMISARTAN AND AMLODIPINE TABLETS 40/5M | $3.2M | 228 |
| TELMISARTAN AND AMLODIPINE TABLETS 80/5M | $2.7M | 187 |
| TELMISARTAN AND AMLODIPINE TABLETS 80/10 | $1.7M | 117 |
| AMLODIPINE BESYLATE TABS USP 10MG NDC N | $1.3M | 52 |
| AMLODIPINE BESYLATE TABS USP 5MG NDC No | $564.7K | 27 |
| AMLOPRES 5 TABLET (AMLODIPINE BESYLATE 5 | $486.3K | 25 |
| TELMISARTAN AND AMLODIPINE TABLETS 40/10 | $379.8K | 27 |
| TELMISARTAN AND AMLODIPINE TABLETS80/10M | $302.3K | 22 |
| AMLODIPINE BESYLATE TABS USP 10MG; NDC N | $264.1K | 12 |
| AMLOPRES 5 TABLET AMLODIPINE BESYLATE | $230.0K | 10 |
Cipla Limited exports 1142 distinct Amlodipine formulations including tablets, capsules, syrups, and combination drugs. The top formulation is TELMISARTAN AND AMLODIPINE TABLETS 40/5M with 228 shipments worth $3.2M. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Amlodipine to Key Markets
What Cipla Limited must comply with to export Amlodipine to its top destination countries
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.
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 Cipla Limited Compare to Nearest Amlodipine Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | CIPLA LIMITED ★ | $101.8M | 2,036 | 15 | $50.0K |
| 4 | ALKEM LABORATORIES LIMITED | $37.3M | 746 | 4 | $50.0K |
| 2 | UNICHEM LABORATORIES LIMITED | $34.5M | 689 | 9 | $50.0K |
Cipla Limited ranks #1 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 ALKEM LABORATORIES LIMITED and UNICHEM 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% |
What Other Cardiovascular Products Does Cipla Limited Export?
Cipla Limited also exports these cardiovascular products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Cipla Limited's Amlodipine Exports
Cipla's export operations are currently navigating a complex geopolitical landscape. The Israel-Iran conflict has led to disruptions in Red Sea shipping routes, resulting in increased freight costs and extended transit times. These challenges are particularly acute for time-sensitive pharmaceutical shipments, necessitating strategic adjustments in logistics and supply chain management.
In the United States, recent import policies, including the imposition of 100% tariffs on branded or patented pharmaceutical products effective October 2025, have introduced additional hurdles for Indian exporters. While generic drugs, a significant component of Cipla's portfolio, may be less affected, the overall trade environment demands vigilance and adaptability. Conversely, the India-European Union Free Trade Agreement, concluded in January 2026, offers a promising avenue for Cipla. The agreement aims to eliminate tariffs on pharmaceuticals, potentially enhancing Cipla's competitiveness in the European market and offsetting challenges faced in other regions.
Cipla Limited — Regulatory Compliance & Quality Standards
Maintaining stringent quality standards is paramount for Cipla, given the diverse regulatory environments across its export markets. The company has demonstrated a strong commitment to compliance, as evidenced by the U.S. Food and Drug Administration's (FDA) classification of its Bengaluru facility as Voluntary Action Indicated (VAI) in October 2025. This classification is crucial for sustaining and expanding Cipla's presence in the U.S. market. Additionally, the European Union's evolving regulatory framework, including the Falsified Medicines Directive, necessitates continuous adaptation to ensure compliance and maintain market access.
About Cipla Limited
Cipla Limited exports 98 products worth $1.1B. Beyond Amlodipine, top products include Fluticasone, Salbutamol, Telmisartan, Salmeterol, Budesonide. View the complete Cipla Limited profile for full portfolio analysis.
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: Cipla 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 2,577 individual customs records matching Cipla Limited exporting Amlodipine, covering 1142 formulations to 18 countries via 32 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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Cipla Limited
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98 products · $1.1B total trade · 26 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 Amlodipine. For current shipment-level data, contact TransData Nexus.