Unichem Laboratories Limited — Amlodipine Exporter Profile
Indian Pharmaceutical Exporter · #2 for Amlodipine · $34.5M export value · DGFT Verified
Unichem Laboratories Limited is the #2 Indian exporter of Amlodipine with $34.5M in export value and 689 verified shipments. Unichem Laboratories Limited holds a 0.3% market share in Amlodipine exports across 9 countries. The company exports 19 pharmaceutical products worth $241.0M across 9 therapeutic categories.
Unichem Laboratories Limited — Amlodipine Export Profile: Buyers & Destinations
Where Does Unichem Laboratories Limited Export Amlodipine?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $18.5M | 680 | 91.3% |
| SOUTH AFRICA | $775.2K | 24 | 3.8% |
| FRANCE | $719.0K | 44 | 3.6% |
| IRELAND | $146.8K | 14 | 0.7% |
| MYANMAR | $83.8K | 24 | 0.4% |
| ZIMBABWE | $24.9K | 7 | 0.1% |
| ZAMBIA | $14.4K | 8 | 0.1% |
| TANZANIA | $1.5K | 1 | 0.0% |
| KENYA | $1.3K | 4 | 0.0% |
Unichem Laboratories Limited exports Amlodipine to 9 countries. The largest destination is UNITED STATES accounting for 91.3% of Unichem Laboratories Limited's Amlodipine shipments, followed by SOUTH AFRICA (3.8%) and FRANCE (3.6%). These destinations reflect Unichem Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Amlodipine from Unichem Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| UNICHEM PHARMACEUTICALS (USA) INC. | UNITED STATES | $9.7M | 393 |
| UNICHEM PHARMACEUTICALS USA INC | UNITED STATES | $3.6M | 110 |
| UNICHEM PHARMACEUTICALS (USA), INC | UNITED STATES | $2.1M | 51 |
| UNICHEM PHARMACEUTICALS (USA) INC | UNITED STATES | $1.8M | 71 |
| UNICHEM PHARMACEUTICALS (USA) INC.. | UNITED STATES | $906.6K | 41 |
| ALLOGA FRANCE | FRANCE | $421.1K | 24 |
| UNICHEM S A PTY LTD | SOUTH AFRICA | $250.0K | 5 |
| UNICHEM PHARMACEUTICALS (USA), INC. | UNITED STATES | $241.7K | 5 |
| ALLOGA FRANCE ZA LES | FRANCE | $220.6K | 12 |
| UNICHEM S.A. (PTY) LTD | SOUTH AFRICA | $214.4K | 7 |
Unichem Laboratories Limited supplies Amlodipine to 37 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 Amlodipine Export Value and How Much Does Unichem Laboratories Limited Contribute?
India exported $311.2M worth of Amlodipine through 15,000 shipments from 599 suppliers to 159 countries, serving 1,862 buyers globally. Unichem Laboratories Limited contributes $34.5M to this total, accounting for 0.3% of India's Amlodipine exports. Unichem Laboratories Limited ships Amlodipine to 9 countries through 37 buyers.
What Is the Average Shipment Value for Unichem Laboratories Limited's Amlodipine Exports?
Unichem Laboratories Limited's average Amlodipine shipment value is $50.0K per consignment, based on 689 shipments totaling $34.5M. The largest destination is UNITED STATES (91.3% of Unichem Laboratories Limited's Amlodipine exports).
How Does Unichem Laboratories Limited Compare to Other Indian Amlodipine Exporters?
Unichem Laboratories Limited ranks #2 among 599 Indian Amlodipine exporters with a 0.3% market share. The top 3 exporters are CIPLA LIMITED ($101.8M), ALKEM LABORATORIES LIMITED ($37.3M), UNICHEM LABORATORIES LIMITED ($34.5M). Unichem Laboratories Limited processed 689 shipments to 9 destination countries.
What Amlodipine Formulations Does Unichem Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| FINISHED FORMULATION-AMLODIPINE BESYLATE | $973.8K | 28 |
| HARMLESS MEDICINES : AMLODIPINE BESYLATE 10MGUSP TABLETS 1000TAmlodipine Besylate Tablets 10mgNDC Code: 29300 | $833.3K | 20 |
| AMLODIPINE BESYLATE 5MG TABLETS 1000T Am | $734.8K | 19 |
| FINISHED FORMULATION AMLODIPINE BESYLATE | $729.8K | 22 |
| AMLODIPINE BESYLATE 10MG TABLETS 1000T A | $631.0K | 15 |
| HARMLESS MEDICINES : AMLODIPINE BESYLATE 5MGUSP TABLETS 1000TAmlodipine Besylate Tablets USP5mg1000TNDC Code: | $614.3K | 13 |
| AMLODIPINE BESYLATE 10MG TABLETS 1000T ( | $421.0K | 11 |
| AMLODIPINE BESYLATE 5MG USP TABLETS 1000T AMLODIPINE BESYLATE TABLETS USP 5MG1000T NDC CODE: 2930039710 1000T | $417.3K | 11 |
| HARMLESS MEDICINES : AMLODIPINE BESYLATE 5MGUSP TABLETS 500TAmlodipine Besylate Tablets USP5mg500TNDC Code: 2 | $387.2K | 11 |
| AMLODIPINE BESYLATE 10MG TABLETS 500T (A | $309.1K | 9 |
Unichem Laboratories Limited exports 321 distinct Amlodipine formulations including tablets, capsules, syrups, and combination drugs. The top formulation is FINISHED FORMULATION-AMLODIPINE BESYLATE with 28 shipments worth $973.8K.
Regulatory Requirements: Exporting Amlodipine to Key Markets
What Unichem Laboratories Limited 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.
South Africa — SAHPRA
Approval Process
Registration under SAHPRA guidelines (CTD format). Bioequivalence required for generics.
Timeline: 24–48 months (significant backlog)
GMP & Export Requirements
WHO GMP or PIC/S GMP compliance
Certificate of Pharmaceutical Product from CDSCO; Import permit per Section 22A of Medicines Act
Note: Known registration backlog. WHO Prequalification significantly assists the process.
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 Amlodipine Exporters?
Exporters ranked immediately above and below #2 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 |
| 5 | IPCA LABORATORIES LIMITED | $21.9M | 438 | 14 | $50.0K |
| 3 | MYLAN LABORATORIES LIMITED | $19.4M | 387 | 11 | $50.0K |
Unichem Laboratories Limited ranks #2 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 CIPLA LIMITED and ALKEM 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 Unichem Laboratories Limited Export?
Unichem Laboratories Limited also exports these cardiovascular products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Unichem Laboratories Limited's Amlodipine 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 Amlodipine, top products include Iron, Allopurinol, Hydrochlorothiazide, Bisoprolol, Meloxicam. View the complete Unichem Laboratories 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: 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 806 individual customs records matching Unichem Laboratories Limited exporting Amlodipine, covering 321 formulations to 9 countries via 37 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
Get Amlodipine 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 Amlodipine. For current shipment-level data, contact TransData Nexus.