Gland Pharma Limited — Azithromycin Exporter Profile
Indian Pharmaceutical Exporter · #12 for Azithromycin · $1.1M export value · DGFT Verified
Gland Pharma Limited is the #12 Indian exporter of Azithromycin with $1.1M in export value and 21 verified shipments. Gland Pharma Limited holds a 0.6% market share in Azithromycin exports across 3 countries. The company exports 29 pharmaceutical products worth $262.0M across 15 therapeutic categories.
Gland Pharma Limited — Azithromycin Export Profile: Buyers & Destinations
Where Does Gland Pharma Limited Export Azithromycin?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.5M | 33 | 71.1% |
| SAUDI ARABIA | $315.8K | 7 | 14.8% |
| BRAZIL | $248.5K | 5 | 11.7% |
| UNITED STATES OF AMERICA | $50.0K | 1 | 2.3% |
| BELARUS | $37 | 2 | 0.0% |
Gland Pharma Limited exports Azithromycin to 5 countries. The largest destination is UNITED STATES accounting for 71.1% of Gland Pharma Limited's Azithromycin shipments, followed by SAUDI ARABIA (14.8%) and BRAZIL (11.7%). These destinations reflect Gland Pharma Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Azithromycin from Gland Pharma Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| EVERSANA | UNITED STATES | $506.7K | 12 |
| ATHENEX PHARMACEUTICAL DIVISION | UNITED STATES | $400.0K | 8 |
| BOSTON ONCOLOGY ARABIA | SAUDI ARABIA | $315.8K | 7 |
| ATHENEX PHARMACEUTICAL DIVISION LLC | UNITED STATES | $300.0K | 6 |
| SUN PHARMACEUTICAL INDUSTRIES INC. | UNITED STATES | $258.3K | 6 |
| ANTIBIOTICOS DO BRASIL LTDA | BRAZIL | $198.5K | 4 |
| TARO PHARMACEUTICAL USA INC | UNITED STATES OF AMERICA | $100.0K | 2 |
| ANTIBIOTICOS DO BRASIL LIMITED A RUA VER GERMANO | BRAZIL | $50.0K | 1 |
| NIKA PHARMACEFTIKA LIMITED | BELARUS | $37 | 2 |
Gland Pharma Limited supplies Azithromycin to 9 buyers globally. The largest buyer is EVERSANA (UNITED STATES), followed by ATHENEX PHARMACEUTICAL DIVISION (UNITED STATES) and BOSTON ONCOLOGY ARABIA (SAUDI ARABIA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Azithromycin Export Value and How Much Does Gland Pharma Limited Contribute?
India exported $74.0M worth of Azithromycin through 15,000 shipments from 853 suppliers to 169 countries, serving 2,397 buyers globally. Gland Pharma Limited contributes $1.1M to this total, accounting for 0.6% of India's Azithromycin exports. Gland Pharma Limited ships Azithromycin to 5 countries through 9 buyers.
What Is the Average Shipment Value for Gland Pharma Limited's Azithromycin Exports?
Gland Pharma Limited's average Azithromycin shipment value is $50.0K per consignment, based on 21 shipments totaling $1.1M. The largest destination is UNITED STATES (71.1% of Gland Pharma Limited's Azithromycin exports).
How Does Gland Pharma Limited Compare to Other Indian Azithromycin Exporters?
Gland Pharma Limited ranks #12 among 853 Indian Azithromycin exporters with a 0.6% market share. The top 3 exporters are LUPIN LIMITED ($11.0M), ALEMBIC PHARMACEUTICALS LIMITED ($8.7M), CIPLA LIMITED ($8.4M). Gland Pharma Limited processed 21 shipments to 3 destination countries.
What Azithromycin Formulations Does Gland Pharma Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| AZITHROMYCIN FOR INJECTION USP 500MG/VIAL | $746.0K | 16 |
| AZITHROMYCIN FOR INJECTION USP 500MG/ML, | $350.0K | 7 |
| AZITHROMYCIN FOR INJECTION USP 500MG/VIA | $300.0K | 6 |
| AZITHROMYCIN FOR INJECTION 500MG/VIAL, 10ML VIAL,(AZITHROMYCIN BOS) | $215.8K | 5 |
| AZITHROMYCIN FOR INJECTION USP 500MG/VIAL,10ML VIAL | $109.2K | 3 |
| AZITHROMYCIN FOR INJECTION USP 500MG PERVIALNOS | $108.3K | 3 |
| AZITHROMYCIN FOR INJECTION USP 500MG PER | $100.0K | 2 |
| AZITHROMYCIN FOR INJECTION 500MG VIAL 10ML VIAL AZITHROMYCIN BOS | $100.0K | 2 |
| AZITHROMYCIN FOR INJECTION USP 500MG VIAL | $50.0K | 1 |
| AZITHROMYCIN FOR INJECTION USP 500MG PERVIAL | $50.0K | 1 |
Gland Pharma Limited exports 11 distinct Azithromycin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is AZITHROMYCIN FOR INJECTION USP 500MG/VIAL with 16 shipments worth $746.0K.
Regulatory Requirements: Exporting Azithromycin to Key Markets
What Gland Pharma Limited must comply with to export Azithromycin 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.
Brazil — ANVISA
Approval Process
Generic registration under RDC 200/2017. ANVISA GMP inspection of Indian facility mandatory before approval.
Timeline: 12–24 months
GMP & Export Requirements
ANVISA GMP certificate (CBPF) for each manufacturing site; on-site inspection by ANVISA
Certificate of Pharmaceutical Product from CDSCO; Import Authorization via SISCOMEX
Note: ANVISA maintains active Indian pharma facility inspection program. Inspection backlog can extend timelines.
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 Gland Pharma Limited Compare to Nearest Azithromycin Exporters?
Exporters ranked immediately above and below #12 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 14 | SCOTT EDIL PHARMACIA LIMITED | $2.7M | 68 | 18 | $40.3K |
| 15 | MEDOPHARM | $2.3M | 103 | 23 | $22.2K |
| 12 | GLAND PHARMA LIMITED ★ | $1.1M | 21 | 3 | $50.0K |
| 9 | ANANT PHARMACEUTICS | $550.0K | 11 | 1 | $50.0K |
Gland Pharma Limited ranks #12 among 853 Indian Azithromycin exporters. Average shipment value of $50.0K compared to the market average of $86.8K. The closest competitors by value are SCOTT EDIL PHARMACIA LIMITED and MEDOPHARM.
Which Indian Ports Ship Azithromycin Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR CARGO ACC (INBOM4) | 2,394 | 16.0% |
| SAHAR AIR | 2,211 | 14.7% |
| DELHI AIR CARGO ACC (INDEL4) | 1,693 | 11.3% |
| DELHI AIR | 1,106 | 7.4% |
| JNPT/ NHAVA SHEVA SEA | 902 | 6.0% |
| NHAVA SHEVA SEA (INNSA1) | 870 | 5.8% |
| Bombay Air | 618 | 4.1% |
| JNPT | 408 | 2.7% |
What Other Antibiotics Products Does Gland Pharma Limited Export?
Gland Pharma Limited also exports these antibiotics products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Gland Pharma Limited's Azithromycin Exports
The current geopolitical landscape presents both challenges and opportunities for Indian pharmaceutical exporters like Gland Pharma. The 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. This escalation in shipping costs directly impacts the profitability of exports to Europe and the U.S. East Coast, necessitating strategic adjustments in logistics and pricing strategies. (sgeexport.com)
Conversely, the India–European Union Free Trade Agreement (FTA), concluded on January 27, 2026, offers a favorable outlook. The agreement eliminates tariffs on most European optical, medical, surgical, and pharmaceutical exports to India, and vice versa, potentially enhancing Gland Pharma's competitiveness in the European market. This development aligns with the company's strategic objectives to deepen market penetration and increase market share within existing therapeutic areas. (en.wikipedia.org)
Gland Pharma Limited — Regulatory Compliance & Quality Standards
Maintaining compliance with international regulatory standards is paramount for Gland Pharma's export operations. The company's Visakhapatnam facility's recent EIR from the USFDA underscores its commitment to quality and regulatory adherence. (business-standard.com) Additionally, the Danish Medicines Agency's Good Manufacturing Practice (GMP) compliance certification for Gland Pharma's facility further validates its manufacturing excellence. (ainvest.com)
However, challenges persist, as evidenced by the French drug regulator ANSM's issuance of ten observations to Gland Pharma's subsidiary, Cenexi, following a GMP inspection. The company is actively addressing these observations, reflecting its proactive approach to regulatory compliance and continuous improvement. (business-standard.com)
About Gland Pharma Limited
Gland Pharma Limited exports 29 products worth $262.0M. Beyond Azithromycin, top products include Heparin, Enoxaparin, Syringe, Ketorolac, Sodium. View the complete Gland Pharma Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Azithromycin — 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: Azithromycin shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Gland Pharma 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 48 individual customs records matching Gland Pharma Limited exporting Azithromycin, covering 11 formulations to 5 countries via 9 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 169+ countries, 2,397+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Azithromycin Export Data from Gland Pharma Limited
Access shipment-level details, pricing data, buyer connections, and competitive analysis for Gland Pharma Limited's Azithromycin exports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
Gland Pharma Limited
Full Company Profile →
29 products · $262.0M total trade · 15 categories
Azithromycin 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 Azithromycin. For current shipment-level data, contact TransData Nexus.