Cipla Limited — Darunavir Exporter Profile
Indian Pharmaceutical Exporter · #6 for Darunavir · $1.6M export value · DGFT Verified
Cipla Limited is the #6 Indian exporter of Darunavir with $1.6M in export value and 31 verified shipments. Cipla Limited holds a 4.4% market share in Darunavir exports across 9 countries. The company exports 98 pharmaceutical products worth $1.1B across 26 therapeutic categories.
Cipla Limited — Darunavir Export Profile: Buyers & Destinations
Where Does Cipla Limited Export Darunavir?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $739.3K | 15 | 58.9% |
| ECUADOR | $263.2K | 7 | 21.0% |
| SOUTH AFRICA | $74.9K | 2 | 6.0% |
| PARAGUAY | $63.3K | 2 | 5.0% |
| COSTA RICA | $50.0K | 1 | 4.0% |
| GUATEMALA | $32.8K | 1 | 2.6% |
| EL SALVADOR | $16.2K | 1 | 1.3% |
| ALBANIA | $12.9K | 1 | 1.0% |
| EGYPT | $3.2K | 1 | 0.3% |
Cipla Limited exports Darunavir to 9 countries. The largest destination is UNITED STATES accounting for 58.9% of Cipla Limited's Darunavir shipments, followed by ECUADOR (21.0%) and SOUTH AFRICA (6.0%). These destinations reflect Cipla Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Darunavir from Cipla Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| CIPLA USA INC UPS SUPPLY CHAIN SOLU | UNITED STATES | $590.2K | 12 |
| MINISTERIO DE SALUD PBLICA DEL ECUA | ECUADOR | $150.0K | 3 |
| CIPLA USA INC UPS SUPPLY CHAIN SOL | UNITED STATES | $149.0K | 3 |
| MINISTERIO DE | GUATEMALA | $146.0K | 5 |
| MINISTERIO DE SALUD PUBLICA Y | PARAGUAY | $63.3K | 2 |
| MEDPRO PHARMACEUTICA PTY LIMITED | SOUTH AFRICA | $50.0K | 1 |
| CAJA COSTARRICENSE DE | COSTA RICA | $50.0K | 1 |
| MEDPRO PHARMACEUTICA (PTY) LTD, | SOUTH AFRICA | $24.9K | 1 |
| MINISTERIO DE SALUD PROGRAMA DE ITS | EL SALVADOR | $16.2K | 1 |
| UNIVERSITY HOSPITAL CENTER | ALBANIA | $12.9K | 1 |
Cipla Limited supplies Darunavir to 11 buyers globally. The largest buyer is CIPLA USA INC UPS SUPPLY CHAIN SOLU (UNITED STATES), followed by MINISTERIO DE SALUD PBLICA DEL ECUA (ECUADOR) 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 Darunavir Export Value and How Much Does Cipla Limited Contribute?
India exported $33.1M worth of Darunavir through 711 shipments from 28 suppliers to 114 countries, serving 258 buyers globally. Cipla Limited contributes $1.6M to this total, accounting for 4.4% of India's Darunavir exports. Cipla Limited ships Darunavir to 9 countries through 11 buyers.
What Is the Average Shipment Value for Cipla Limited's Darunavir Exports?
Cipla Limited's average Darunavir shipment value is $50.0K per consignment, based on 31 shipments totaling $1.6M. The largest destination is UNITED STATES (58.9% of Cipla Limited's Darunavir exports).
How Does Cipla Limited Compare to Other Indian Darunavir Exporters?
Cipla Limited ranks #6 among 28 Indian Darunavir exporters with a 4.4% market share. The top 3 exporters are MYLAN LABORATORIES LIMITED ($13.4M), HETERO LABS LIMITED ($11.3M), MSN LABORATORIES PRIVATE LIMITED ($3.2M). Cipla Limited processed 31 shipments to 9 destination countries.
What Darunavir Formulations Does Cipla Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| DARUNAVIR TABLETS 600MG PACK SIZE 1 X 60 | $150.0K | 3 |
| DARUNAVIR TABLETS 800MG PACK SIZE 1 X 30S | $100.0K | 2 |
| DARUNAVIR TABLETS 800 MG PACK SIZE 1 X 30S | $100.0K | 2 |
| DARUNAVIR TABLETS 600 MG PACK SIZE 1 X 60S | $100.0K | 2 |
| DARUNAVIR TABLETS 600MG PACK SIZE 1 X 60S | $100.0K | 2 |
| DARUNAVIR TABLETS 600MG (1610 PACK X1X60 | $50.0K | 1 |
| PARANVIR 400 TABLET DARUNAVIR 400 MG | $50.0K | 1 |
| DARUNAVIR TABLETS 600MG 1120 PACKx1X60'S=67200 NOS | $50.0K | 1 |
| DARUNAVIR TABLETS 600MG 1871PACKS 1X60'S=112260 NOS | $50.0K | 1 |
| DARUNAVIR TABLETS 600MG 1907 PACKS 1X60'S=114420 NOS | $50.0K | 1 |
Cipla Limited exports 25 distinct Darunavir formulations including tablets, capsules, syrups, and combination drugs. The top formulation is DARUNAVIR TABLETS 600MG PACK SIZE 1 X 60 with 3 shipments worth $150.0K.
Regulatory Requirements: Exporting Darunavir to Key Markets
What Cipla Limited must comply with to export Darunavir 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 Cipla Limited Compare to Nearest Darunavir Exporters?
Exporters ranked immediately above and below #6 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 5 | MSN LABORATORIES PRIVATE LIMITED | $3.2M | 68 | 9 | $46.4K |
| 4 | ANNORA PHARMA PRIVATE LIMITED | $2.8M | 55 | 5 | $50.0K |
| 6 | CIPLA LIMITED ★ | $1.6M | 31 | 9 | $50.0K |
| 7 | APL HEALTHCARE LIMITED | $350.0K | 7 | 3 | $50.0K |
| 2 | LUPIN LIMITED | $250.0K | 5 | 1 | $50.0K |
Cipla Limited ranks #6 among 28 Indian Darunavir exporters. Average shipment value of $50.0K compared to the market average of $1.2M. The closest competitors by value are MSN LABORATORIES PRIVATE LIMITED and ANNORA PHARMA PRIVATE LIMITED.
Which Indian Ports Ship Darunavir Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 165 | 23.2% |
| SAHAR AIR CARGO ACC (INBOM4) | 121 | 17.0% |
| HYDERABAD AIR | 85 | 12.0% |
| HYDERABAD ACC (INHYD4) | 59 | 8.3% |
| NHAVA SHEVA SEA (INNSA1) | 40 | 5.6% |
| HYDERABAD ICD (INSNF6) | 33 | 4.6% |
| HYDERABAD ICD | 30 | 4.2% |
| Bombay Air | 22 | 3.1% |
Geopolitical & Trade Policy Impact on Cipla Limited's Darunavir 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 Darunavir, top products include Fluticasone, Amlodipine, Salbutamol, Telmisartan, Salmeterol. View the complete Cipla Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Darunavir — 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: Darunavir 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 31 individual customs records matching Cipla Limited exporting Darunavir, covering 25 formulations to 9 countries via 11 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 114+ countries, 258+ 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 Darunavir. For current shipment-level data, contact TransData Nexus.