Granules India Limited — Metformin Exporter Profile
Indian Pharmaceutical Exporter · #1 for Metformin · $113.9M export value · DGFT Verified
Granules India Limited is the #1 Indian exporter of Metformin with $113.9M in export value and 2,278 verified shipments. Granules India Limited holds a 24.4% market share in Metformin exports across 19 countries. The company exports 20 pharmaceutical products worth $412.3M across 9 therapeutic categories.
Granules India Limited — Metformin Export Profile: Buyers & Destinations
Where Does Granules India Limited Export Metformin?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $98.8M | 2,728 | 66.4% |
| FRANCE | $12.6M | 392 | 8.5% |
| CANADA | $5.3M | 130 | 3.6% |
| NETHERLANDS | $5.0M | 161 | 3.4% |
| UNITED STATES OF AMERICA | $4.7M | 112 | 3.2% |
| SPAIN | $4.3M | 101 | 2.9% |
| UNITED KINGDOM | $3.5M | 174 | 2.3% |
| ITALY | $3.5M | 101 | 2.3% |
| MALTA | $2.2M | 73 | 1.5% |
| SOUTH AFRICA | $1.9M | 101 | 1.2% |
Granules India Limited exports Metformin to 24 countries. The largest destination is UNITED STATES accounting for 66.4% of Granules India Limited's Metformin shipments, followed by FRANCE (8.5%) and CANADA (3.6%). These destinations reflect Granules India Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Metformin from Granules India Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| GRANULES PHARMACEUTICALS, INC. | UNITED STATES | $35.6M | 971 |
| GRANULES PHARMACEUTICALS INC | UNITED STATES | $28.1M | 726 |
| GRANULES PHARMACEUTICALS, INC | UNITED STATES | $22.4M | 746 |
| CSP VIATRIS SANTE AT CSP- LAB | FRANCE | $5.3M | 201 |
| MYLAN PHARMACEUTICALS INC | UNITED STATES | $5.2M | 109 |
| ASCEND LABORATORIES LLC | UNITED STATES | $4.2M | 97 |
| MANX HEALTHCARE | UNITED KINGDOM | $3.3M | 168 |
| SAG MANUFACTURING SLU | SPAIN | $3.2M | 66 |
| PRIORITY HEALTHCARE DISTRIBUTION | UNITED STATES | $2.9M | 68 |
| CSP MYLAN SAS AT CSP-LABO 274 | FRANCE | $2.7M | 65 |
Granules India Limited supplies Metformin to 102 buyers globally. The largest buyer is GRANULES PHARMACEUTICALS, INC. (UNITED STATES), followed by GRANULES PHARMACEUTICALS INC (UNITED STATES) and GRANULES PHARMACEUTICALS, INC (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Metformin Export Value and How Much Does Granules India Limited Contribute?
India exported $266.5M worth of Metformin through 15,000 shipments from 528 suppliers to 160 countries, serving 1,475 buyers globally. Granules India Limited contributes $113.9M to this total, accounting for 24.4% of India's Metformin exports. Granules India Limited ships Metformin to 24 countries through 102 buyers.
What Is the Average Shipment Value for Granules India Limited's Metformin Exports?
Granules India Limited's average Metformin shipment value is $50.0K per consignment, based on 2,278 shipments totaling $113.9M. The largest destination is UNITED STATES (66.4% of Granules India Limited's Metformin exports).
How Does Granules India Limited Compare to Other Indian Metformin Exporters?
Granules India Limited ranks #1 among 528 Indian Metformin exporters with a 24.4% market share. The top 3 exporters are GRANULES INDIA LIMITED ($113.9M), ZENTIVA PRIVATE LIMITED ($19.4M), IPCA LABORATORIES LIMITED ($17.1M). Granules India Limited processed 2,278 shipments to 19 destination countries.
What Metformin Formulations Does Granules India Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| METFORMIN HYDROCHLORIDE TABLETS USP 1000 | $8.6M | 198 |
| METFORMIN HYDROCHLORIDE TABLETS USP 500M | $5.5M | 136 |
| METFORMIN HCL EXTENDED-RELEASE TABLETS, | $3.4M | 72 |
| METFORMIN TABLETS 850 MG (GALENICUM - SA | $2.5M | 49 |
| Metformin HCl BB 500mg T 500s Metformin | $2.1M | 42 |
| METFORMIN HYDROCHLORIDE 500MG FILM-COTED | $1.3M | 60 |
| METFORMIN HCL EXTENDED RELEASE TABLETS, | $1.3M | 25 |
| METFORMIN HCL EXTENDED-RELEASE TABLETS | $1.2M | 24 |
| METFORMIN HYDROCHLORIDE EXTENDED RELEASE | $1.1M | 42 |
| METFORMIN HYDROCHLORIDE 850MG FILM-COATE | $869.2K | 36 |
Granules India Limited exports 1897 distinct Metformin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is METFORMIN HYDROCHLORIDE TABLETS USP 1000 with 198 shipments worth $8.6M.
Regulatory Requirements: Exporting Metformin to Key Markets
What Granules India Limited must comply with to export Metformin 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.
Canada — HC
Approval Process
ANDS (Abbreviated New Drug Submission) referencing Canadian Reference Product. Comparative bioavailability study required.
Timeline: 12–18 months
GMP & Export Requirements
Health Canada GMP (GUI-0001); Drug Establishment Licence (DEL) inspection
Drug Identification Number (DIN) for each product; Certificate of Pharmaceutical Product from CDSCO
Note: Subject to Good Import Practices and annual C.01.014.6 review.
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 Metformin Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | GRANULES INDIA LIMITED ★ | $113.9M | 2,278 | 19 | $50.0K |
| 5 | ZENTIVA PRIVATE LIMITED | $19.4M | 585 | 5 | $33.2K |
| 4 | IPCA LABORATORIES LIMITED | $17.1M | 342 | 14 | $50.0K |
Granules India Limited ranks #1 among 528 Indian Metformin exporters. Average shipment value of $50.0K compared to the market average of $504.7K. The closest competitors by value are ZENTIVA PRIVATE LIMITED and IPCA LABORATORIES LIMITED.
Which Indian Ports Ship Metformin Exports?
| Port | Shipments | % Share |
|---|---|---|
| NHAVA SHEVA SEA (INNSA1) | 2,284 | 15.2% |
| SAHAR AIR CARGO ACC (INBOM4) | 1,638 | 10.9% |
| HYDERABAD ICD (INSNF6) | 1,593 | 10.6% |
| DELHI AIR CARGO ACC (INDEL4) | 1,355 | 9.0% |
| SAHAR AIR | 1,015 | 6.8% |
| JNPT/ NHAVA SHEVA SEA | 843 | 5.6% |
| DELHI AIR | 711 | 4.7% |
| Bombay Air | 695 | 4.6% |
Geopolitical & Trade Policy Impact on Granules India Limited's Metformin 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 Metformin, top products include Acetaminophen, Amino, Ibuprofen, Potassium, Paracetamol. View the complete Granules India Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Metformin — 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: Metformin 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 4,305 individual customs records matching Granules India Limited exporting Metformin, covering 1897 formulations to 24 countries via 102 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 160+ countries, 1,475+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Metformin Export Data from Granules India Limited
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Granules India Limited
Full Company Profile →
20 products · $412.3M total trade · 9 categories
Metformin 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 Metformin. For current shipment-level data, contact TransData Nexus.