Caplin Steriles Limited — Phenylephrine Exporter Profile
Indian Pharmaceutical Exporter · #2 for Phenylephrine · $3.3M export value · DGFT Verified
Caplin Steriles Limited is the #2 Indian exporter of Phenylephrine with $3.3M in export value and 65 verified shipments. Caplin Steriles Limited holds a 3.8% market share in Phenylephrine exports across 3 countries. The company exports 4 pharmaceutical products worth $16.0M across 3 therapeutic categories.
Caplin Steriles Limited — Phenylephrine Export Profile: Buyers & Destinations
Where Does Caplin Steriles Limited Export Phenylephrine?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $2.7M | 59 | 90.1% |
| AUSTRALIA | $150.0K | 3 | 4.9% |
| UNITED ARAB EMIRATES | $150.0K | 3 | 4.9% |
Caplin Steriles Limited exports Phenylephrine to 3 countries. The largest destination is UNITED STATES accounting for 90.1% of Caplin Steriles Limited's Phenylephrine shipments, followed by AUSTRALIA (4.9%) and UNITED ARAB EMIRATES (4.9%). These destinations reflect Caplin Steriles Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Phenylephrine from Caplin Steriles Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| SOMERSET THERAPEUTICS | UNITED STATES | $832.9K | 17 |
| CARDINAL 3PL | UNITED STATES | $570.2K | 12 |
| SOMERSET THERAPEUTICS, LLC | UNITED STATES | $367.6K | 8 |
| SOMERSET THERAPEUTICS LLC | UNITED STATES | $281.3K | 6 |
| SOMERSET THERAPEUTICS,LLC | UNITED STATES | $222.1K | 6 |
| SOMERSET THERAPEAUTICS LLC | UNITED STATES | $200.0K | 4 |
| TRANS ARABIA DRUG STORE | UNITED ARAB EMIRATES | $150.0K | 3 |
| CAPLIN STERILES USA INC | UNITED STATES | $135.0K | 3 |
| BAXTER HEALTHCARE PTY LIMITED LIMITED | AUSTRALIA | $100.0K | 2 |
| SOLA PHARMACEUTICALS | UNITED STATES | $87.0K | 2 |
Caplin Steriles Limited supplies Phenylephrine to 12 buyers globally. The largest buyer is SOMERSET THERAPEUTICS (UNITED STATES), followed by CARDINAL 3PL (UNITED STATES) and SOMERSET THERAPEUTICS, LLC (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Phenylephrine Export Value and How Much Does Caplin Steriles Limited Contribute?
India exported $31.9M worth of Phenylephrine through 4,787 shipments from 541 suppliers to 157 countries, serving 1,210 buyers globally. Caplin Steriles Limited contributes $3.3M to this total, accounting for 3.8% of India's Phenylephrine exports. Caplin Steriles Limited ships Phenylephrine to 3 countries through 12 buyers.
What Is the Average Shipment Value for Caplin Steriles Limited's Phenylephrine Exports?
Caplin Steriles Limited's average Phenylephrine shipment value is $50.0K per consignment, based on 65 shipments totaling $3.3M. The largest destination is UNITED STATES (90.1% of Caplin Steriles Limited's Phenylephrine exports).
How Does Caplin Steriles Limited Compare to Other Indian Phenylephrine Exporters?
Caplin Steriles Limited ranks #2 among 541 Indian Phenylephrine exporters with a 3.8% market share. The top 3 exporters are MANKIND PHARMA LIMITED ($6.8M), ELYSIUM PHARMACEUTICALS LTD ($3.8M), COMBITIC GLOBAL CAPLET PRIVATE LIMITED ($3.7M). Caplin Steriles Limited processed 65 shipments to 3 destination countries.
What Phenylephrine Formulations Does Caplin Steriles Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| Phenylephrine Hydrochloride Injection, U | $317.6K | 7 |
| PHENYLEPHRINE HYDROCHLORIDE INJECTION US | $150.0K | 3 |
| (P/N:25000042) PHENYLEPHRINE HYDROCHLORI | $100.0K | 2 |
| PHENYLEPHRINE HYDROCHLORIDE INJECTION USP 10MG ML 1ML FDA PRODUCT CODE 60 C CP 09 BATCH NO 90000220 Jan 23 Dec 24 | $100.0K | 2 |
| ITEM NO:CPPHE10VAUSAP ITEM CODE:25000346PHENYLEPHRINE HYDROCHLORIDE INJECTION USP 10MG/ML-1ML BATCH NO:90000453 | $100.0K | 2 |
| PHENYLEPHRINE HYDROCHLORIDE INJECTION USP 10MG/ML - 1ML | $100.0K | 2 |
| (P/N:25000043) PHENYLEPHRINE HYDROCHLORI | $92.5K | 3 |
| PHENYLEPHRINE HYDROCHLORIDE INJECTION USP 50MG/5ML 10MG/ML -5MLBATCH NO.90000457 | $91.5K | 2 |
| PHENYLEPHRINE HYDROCHLORIDE INJECTION USP 10MG ML 5ML FDA PRODUCT CODE 60 C CP 09 BATCH NO 90000226 Jan 23 Dec 24 | $88.7K | 2 |
| PHENYLEPHRINE HYDROCHLORIDE INJECTION USP 10MG/ML-5ML BATCH NO.90000394 | $50.0K | 1 |
Caplin Steriles Limited exports 49 distinct Phenylephrine formulations including tablets, capsules, syrups, and combination drugs. The top formulation is Phenylephrine Hydrochloride Injection, U with 7 shipments worth $317.6K.
Regulatory Requirements: Exporting Phenylephrine to Key Markets
What Caplin Steriles Limited must comply with to export Phenylephrine 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.
Australia — TGA
Approval Process
Registration on Australian Register of Therapeutic Goods (ARTG). Bioequivalence and quality data per TGA guidelines.
Timeline: 10–14 months
GMP & Export Requirements
TGA GMP clearance; PIC/S-aligned inspection. PIC/S certificate from India may expedite.
TGA sponsor licence for Australian importer; GMP clearance per manufacturing site
Note: TGA participates in PIC/S mutual recognition.
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 Caplin Steriles Limited Compare to Nearest Phenylephrine Exporters?
Exporters ranked immediately above and below #2 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 3 | ELYSIUM PHARMACEUTICALS LTD | $3.8M | 75 | 1 | $50.0K |
| 4 | COMBITIC GLOBAL CAPLET PRIVATE LIMITED | $3.7M | 100 | 3 | $36.7K |
| 2 | CAPLIN STERILES LIMITED ★ | $3.3M | 65 | 3 | $50.0K |
| 5 | SOCOMED PHARMA PRIVATE LIMITED | $2.7M | 149 | 8 | $17.9K |
| 7 | INDOCO REMEDIES LIMITED | $2.0M | 66 | 6 | $30.6K |
Caplin Steriles Limited ranks #2 among 541 Indian Phenylephrine exporters. Average shipment value of $50.0K compared to the market average of $59.0K. The closest competitors by value are ELYSIUM PHARMACEUTICALS LTD and COMBITIC GLOBAL CAPLET PRIVATE LIMITED.
Which Indian Ports Ship Phenylephrine Exports?
| Port | Shipments | % Share |
|---|---|---|
| NHAVA SHEVA SEA (INNSA1) | 489 | 10.2% |
| JNPT/ NHAVA SHEVA SEA | 418 | 8.7% |
| SAHAR AIR | 396 | 8.3% |
| JNPT | 330 | 6.9% |
| SAHAR AIR CARGO ACC (INBOM4) | 238 | 5.0% |
| MUNDRA SEA | 199 | 4.2% |
| DELHI AIR | 155 | 3.2% |
| DELHI AIR CARGO ACC (INDEL4) | 145 | 3.0% |
What Other Respiratory & OTC Products Does Caplin Steriles Limited Export?
Caplin Steriles Limited also exports these respiratory & otc products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Caplin Steriles Limited's Phenylephrine Exports
The current geopolitical landscape presents both challenges and opportunities for Indian pharmaceutical exporters like Caplin Steriles. Escalating tensions in the Middle East, particularly the Israel-Iran conflict, have disrupted key shipping routes such as the Red Sea and the Suez Canal. This has led to increased freight costs and extended transit times for shipments to Europe, compelling exporters to seek alternative routes and strategies to maintain supply chain efficiency. (livemint.com)
Conversely, the recent India–European Union Free Trade Agreement (FTA), signed in January 2026, is poised to benefit Indian pharmaceutical exporters by eliminating tariffs on pharmaceutical products. This agreement enhances the competitiveness of Indian pharmaceuticals in the European market, potentially boosting export volumes and market share for companies like Caplin Steriles. (en.wikipedia.org)
Caplin Steriles Limited — Regulatory Compliance & Quality Standards
Maintaining stringent quality standards is paramount for pharmaceutical exporters. Caplin Steriles has demonstrated a strong commitment to regulatory compliance, evidenced by the successful completion of an unannounced USFDA inspection in August 2024, which concluded with zero observations. This outcome underscores the company's adherence to Good Manufacturing Practices (GMP) and its dedication to quality assurance. (caplin-us.com)
As regulatory requirements evolve, particularly in the European Union with the implementation of the Falsified Medicines Directive, Caplin Steriles' proactive compliance measures position it favorably to navigate these changes and maintain its export credentials.
About Caplin Steriles Limited
Caplin Steriles Limited exports 4 products worth $16.0M. Beyond Phenylephrine, top products include Ketorolac, Verapamil, Ephedrine. View the complete Caplin Steriles Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Phenylephrine — 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: Phenylephrine shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Caplin Steriles 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 65 individual customs records matching Caplin Steriles Limited exporting Phenylephrine, covering 49 formulations to 3 countries via 12 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 157+ countries, 1,210+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Phenylephrine Export Data from Caplin Steriles Limited
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Caplin Steriles Limited
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4 products · $16.0M total trade · 3 categories
Phenylephrine Stats
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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 Phenylephrine. For current shipment-level data, contact TransData Nexus.