Granules India Limited — Guaifenesin Exporter Profile
Indian Pharmaceutical Exporter · #1 for Guaifenesin · $9.1M export value · DGFT Verified
Granules India Limited is the #1 Indian exporter of Guaifenesin with $9.1M in export value and 181 verified shipments. Granules India Limited holds a 33.9% market share in Guaifenesin exports across 2 countries. The company exports 20 pharmaceutical products worth $412.3M across 9 therapeutic categories.
Granules India Limited — Guaifenesin Export Profile: Buyers & Destinations
Where Does Granules India Limited Export Guaifenesin?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $6.6M | 177 | 99.0% |
| UNITED STATES OF AMERICA | $68.0K | 2 | 1.0% |
| JORDAN | $36 | 2 | 0.0% |
Granules India Limited exports Guaifenesin to 3 countries. The largest destination is UNITED STATES accounting for 99.0% of Granules India Limited's Guaifenesin shipments, followed by UNITED STATES OF AMERICA (1.0%) and JORDAN (0.0%). These destinations reflect Granules India Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Guaifenesin from Granules India Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| GRANULES CONSUMER HEALTH | UNITED STATES | $4.3M | 116 |
| GRANULES USA INC. | UNITED STATES | $697.1K | 25 |
| PERRIGO COMPANY | UNITED STATES | $600.0K | 12 |
| GRANULES USA INC | UNITED STATES | $559.6K | 15 |
| PERRIGO COMPANY PLANT | UNITED STATES | $250.0K | 5 |
| GRANULES CONSUMER HEALTH, LLC | UNITED STATES | $186.8K | 4 |
| GRANULES CONSUMER HEALTH LLC | UNITED STATES | $50.0K | 1 |
| GRANULES USA A DIVISION OF | UNITED STATES | $42.0K | 1 |
| TO TRIUMPHARMA ATT | JORDAN | $36 | 2 |
Granules India Limited supplies Guaifenesin to 9 buyers globally. The largest buyer is GRANULES CONSUMER HEALTH (UNITED STATES), followed by GRANULES USA INC. (UNITED STATES) and PERRIGO COMPANY (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Guaifenesin Export Value and How Much Does Granules India Limited Contribute?
India exported $19.9M worth of Guaifenesin through 1,050 shipments from 151 suppliers to 77 countries, serving 278 buyers globally. Granules India Limited contributes $9.1M to this total, accounting for 33.9% of India's Guaifenesin exports. Granules India Limited ships Guaifenesin to 3 countries through 9 buyers.
What Is the Average Shipment Value for Granules India Limited's Guaifenesin Exports?
Granules India Limited's average Guaifenesin shipment value is $50.0K per consignment, based on 181 shipments totaling $9.1M. The largest destination is UNITED STATES (99.0% of Granules India Limited's Guaifenesin exports).
How Does Granules India Limited Compare to Other Indian Guaifenesin Exporters?
Granules India Limited ranks #1 among 151 Indian Guaifenesin exporters with a 33.9% market share. The top 3 exporters are GRANULES INDIA LIMITED ($9.1M), ELYSIUM PHARMACEUTICALS LTD ($3.9M), SUN PHARMACEUTICAL INDUSTRIES LIMITED ($899.7K). Granules India Limited processed 181 shipments to 2 destination countries.
What Guaifenesin Formulations Does Granules India Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| Guaifenesin Extended Release Tablets 120 | $500.0K | 10 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 600MG | $450.8K | 12 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 600 | $360.2K | 10 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 1200MG | $349.9K | 8 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 1200MG-14'S | $300.0K | 6 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 120 | $289.3K | 8 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 1200MGNOS | $204.4K | 6 |
| GUAIFENESIN EXTENDED-RELEASE TABLETS 600MGNOS | $154.7K | 6 |
| Guaifenesin Extended Release Tablets 1200mg 14s/Perrigo | $150.0K | 3 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 1200MG-14S(201,000.000PAC) | $150.0K | 3 |
Granules India Limited exports 84 distinct Guaifenesin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is Guaifenesin Extended Release Tablets 120 with 10 shipments worth $500.0K.
Regulatory Requirements: Exporting Guaifenesin to Key Markets
What Granules India Limited must comply with to export Guaifenesin 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.
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 Granules India Limited Compare to Nearest Guaifenesin Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | GRANULES INDIA LIMITED ★ | $9.1M | 181 | 2 | $50.0K |
| 2 | ELYSIUM PHARMACEUTICALS LTD | $3.9M | 77 | 1 | $50.0K |
| 3 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $899.7K | 31 | 1 | $29.0K |
Granules India Limited ranks #1 among 151 Indian Guaifenesin exporters. Average shipment value of $50.0K compared to the market average of $131.8K. The closest competitors by value are ELYSIUM PHARMACEUTICALS LTD and SUN PHARMACEUTICAL INDUSTRIES LIMITED.
Which Indian Ports Ship Guaifenesin Exports?
| Port | Shipments | % Share |
|---|---|---|
| HYDERABAD ICD | 118 | 11.2% |
| NHAVA SHEVA SEA (INNSA1) | 94 | 9.0% |
| JNPT | 74 | 7.0% |
| JNPT/ NHAVA SHEVA SEA | 70 | 6.7% |
| HYDERABAD AIR | 53 | 5.0% |
| HYDERABAD ICD (INSNF6) | 50 | 4.8% |
| MUNDRA SEA (INMUN1) | 50 | 4.8% |
| MUNDRA SEA | 47 | 4.5% |
What Other Respiratory & OTC Products Does Granules India Limited Export?
Granules India Limited also exports these respiratory & otc products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Granules India Limited's Guaifenesin Exports
Granules India's export operations are influenced by various geopolitical factors. The ongoing Israel-Iran tensions have led to disruptions in Red Sea shipping routes, compelling maritime carriers to reroute via the Cape of Good Hope. This has resulted in increased lead times and freight costs, posing challenges for time-sensitive pharmaceutical shipments. To mitigate these risks, Granules India is leveraging its multi-site manufacturing capabilities and strategic inventory positioning. (pharmaceuticalcommerce.com)
The U.S.-China trade tensions have created opportunities for Indian pharmaceutical exporters like Granules India, as global buyers seek to diversify their supply chains. However, compliance with evolving U.S. pharmaceutical import policies remains crucial. In the European Union, the implementation of the Falsified Medicines Directive necessitates stringent serialization and traceability measures. Granules India's proactive approach to regulatory compliance positions it favorably to navigate these complexities and maintain its export momentum.
Granules India Limited — Regulatory Compliance & Quality Standards
Regulatory compliance is paramount for Granules India, given its extensive export operations. The company's Gagillapur facility in Telangana received a warning letter from the U.S. Food and Drug Administration (FDA) in February 2025, following an inspection that identified issues related to equipment maintenance and contamination control. In response, Granules India implemented comprehensive corrective and preventive actions, including engaging independent consultants and enhancing cleaning protocols. The company has been providing regular updates to the FDA and is prepared for re-inspection to demonstrate compliance. (moneycontrol.com)
Conversely, Granules India's U.S.-based packaging facility in Virginia successfully cleared an FDA inspection in December 2025 with zero observations, reflecting the company's commitment to quality and regulatory excellence. (pharma.economictimes.indiatimes.com)
About Granules India Limited
Granules India Limited exports 20 products worth $412.3M. Beyond Guaifenesin, top products include Metformin, Acetaminophen, Amino, Ibuprofen, Potassium. View the complete Granules India Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Guaifenesin — 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: Guaifenesin shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Granules India 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 181 individual customs records matching Granules India Limited exporting Guaifenesin, covering 84 formulations to 3 countries via 9 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 77+ countries, 278+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Guaifenesin Export Data from Granules India Limited
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Granules India Limited
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20 products · $412.3M 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 Guaifenesin. For current shipment-level data, contact TransData Nexus.