Glenmark Pharmaceuticals Limited — Sirolimus Exporter Profile
Indian Pharmaceutical Exporter · #8 for Sirolimus · $214.5K export value · DGFT Verified
Glenmark Pharmaceuticals Limited is the #8 Indian exporter of Sirolimus with $214.5K in export value and 32 verified shipments. Glenmark Pharmaceuticals Limited holds a 1.4% market share in Sirolimus exports across 2 countries. The company exports 28 pharmaceutical products worth $205.5M across 14 therapeutic categories.
Glenmark Pharmaceuticals Limited — Sirolimus Export Profile: Buyers & Destinations
Where Does Glenmark Pharmaceuticals Limited Export Sirolimus?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $155.7K | 4 | 73.0% |
| UNITED STATES OF AMERICA | $57.3K | 2 | 26.9% |
| BRAZIL | $296 | 26 | 0.1% |
Glenmark Pharmaceuticals Limited exports Sirolimus to 3 countries. The largest destination is UNITED STATES accounting for 73.0% of Glenmark Pharmaceuticals Limited's Sirolimus shipments, followed by UNITED STATES OF AMERICA (26.9%) and BRAZIL (0.1%). These destinations reflect Glenmark Pharmaceuticals Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Sirolimus from Glenmark Pharmaceuticals Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| GLENMARK PHARMACEUTICALS INC | UNITED STATES | $155.7K | 4 |
| XXENMXXK PXXRMAXXUTIXXLS XXC | UNITED STATES OF AMERICA | $57.3K | 2 |
| PHARMATECH IMPORTACAO E EXPORTACAO | BRAZIL | $296 | 26 |
Glenmark Pharmaceuticals Limited supplies Sirolimus to 3 buyers globally. The largest buyer is GLENMARK PHARMACEUTICALS INC (UNITED STATES), followed by XXENMXXK PXXRMAXXUTIXXLS XXC (UNITED STATES OF AMERICA) and PHARMATECH IMPORTACAO E EXPORTACAO (BRAZIL). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Sirolimus Export Value and How Much Does Glenmark Pharmaceuticals Limited Contribute?
India exported $6.1M worth of Sirolimus through 1,244 shipments from 97 suppliers to 48 countries, serving 128 buyers globally. Glenmark Pharmaceuticals Limited contributes $214.5K to this total, accounting for 1.4% of India's Sirolimus exports. Glenmark Pharmaceuticals Limited ships Sirolimus to 3 countries through 3 buyers.
What Is the Average Shipment Value for Glenmark Pharmaceuticals Limited's Sirolimus Exports?
Glenmark Pharmaceuticals Limited's average Sirolimus shipment value is $6.7K per consignment, based on 32 shipments totaling $214.5K. The largest destination is UNITED STATES (73.0% of Glenmark Pharmaceuticals Limited's Sirolimus exports).
How Does Glenmark Pharmaceuticals Limited Compare to Other Indian Sirolimus Exporters?
Glenmark Pharmaceuticals Limited ranks #8 among 97 Indian Sirolimus exporters with a 1.4% market share. The top 3 exporters are ALKEM LABORATORIES LIMITED ($2.7M), ZYDUS LIFESCIENCES LIMITED ($1.6M), DR REDDYS LABORATORIES LIMITED ($400.0K). Glenmark Pharmaceuticals Limited processed 32 shipments to 2 destination countries.
What Sirolimus Formulations Does Glenmark Pharmaceuticals Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| SIROLIMUS TAB 2MG 100 | $114.6K | 4 |
| SIROLIMUS TAB 0.5MG 100 | $98.5K | 2 |
| Sirolimus Tablets 2mg (Test Sample) | $149 | 2 |
| Sirolimus Tablets 1mg (Test Sample) | $74 | 2 |
| Sirolimus USP (Analytical Standard) | $36 | 1 |
| Placebo of Sirolimus Tablets 2mg | $8 | 2 |
| Placebo of Sirolimus Tablets 1mg | $6 | 2 |
| Placebo of Sirolimus Tablets 2mg (without Isopropyl Alcohol) | $3 | 2 |
| Placebo of Sirolimus Tablets 1mg (without EDTA) | $2 | 2 |
| Placebo of Sirolimus Tablets 1mg (without Isopropyl Alcohol) | $2 | 2 |
Glenmark Pharmaceuticals Limited exports 18 distinct Sirolimus formulations including tablets, capsules, syrups, and combination drugs. The top formulation is SIROLIMUS TAB 2MG 100 with 4 shipments worth $114.6K.
Regulatory Requirements: Exporting Sirolimus to Key Markets
What Glenmark Pharmaceuticals Limited must comply with to export Sirolimus 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 Glenmark Pharmaceuticals Limited Compare to Nearest Sirolimus Exporters?
Exporters ranked immediately above and below #8 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 4 | DR REDDYS LABORATORIES LIMITED | $400.0K | 8 | 1 | $50.0K |
| 3 | CADILA HEALTHCARE LIMITED | $250.0K | 5 | 1 | $50.0K |
| 8 | GLENMARK PHARMACEUTICALS LIMITED ★ | $214.5K | 32 | 2 | $6.7K |
| 5 | DR REDDY S LABORATORIES LIMITED | $200.0K | 4 | 1 | $50.0K |
| 6 | INTAS PHARMACEUTICALS LIMITED | $200.0K | 4 | 1 | $50.0K |
Glenmark Pharmaceuticals Limited ranks #8 among 97 Indian Sirolimus exporters. Average shipment value of $6.7K compared to the market average of $62.9K. The closest competitors by value are DR REDDYS LABORATORIES LIMITED and CADILA HEALTHCARE LIMITED.
Which Indian Ports Ship Sirolimus Exports?
| Port | Shipments | % Share |
|---|---|---|
| DELHI AIR CARGO ACC (INDEL4) | 384 | 30.9% |
| DELHI AIR | 234 | 18.8% |
| SAHAR AIR CARGO ACC (INBOM4) | 185 | 14.9% |
| SAHAR AIR | 95 | 7.6% |
| Delhi Air | 64 | 5.1% |
| NHAVA SHEVA SEA (INNSA1) | 36 | 2.9% |
| AHEMDABAD AIR | 29 | 2.3% |
| Bombay Air | 25 | 2.0% |
What Other Immunosuppressants Products Does Glenmark Pharmaceuticals Limited Export?
Glenmark Pharmaceuticals Limited also exports these immunosuppressants products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Glenmark Pharmaceuticals Limited's Sirolimus Exports
Glenmark's export operations are influenced by various geopolitical factors. The Israel-Iran tensions have led to disruptions in Red Sea shipping routes, causing increased freight costs and extended transit times. These challenges are particularly impactful for time-sensitive pharmaceutical shipments, necessitating strategic adjustments in logistics and supply chain management. (pharmaceuticalcommerce.com)
Conversely, the US-China trade tensions have opened avenues for Indian pharmaceutical companies like Glenmark to expand their footprint in the US market. The shifting trade dynamics have prompted US importers to seek alternative suppliers, presenting growth opportunities for Indian exporters.
The recent India-European Union Free Trade Agreement (FTA) is poised to benefit Glenmark by eliminating tariffs on pharmaceutical exports to the EU. This development enhances the company's competitiveness in the European market, potentially boosting export volumes and revenue streams. (en.wikipedia.org)
Glenmark Pharmaceuticals Limited — Regulatory Compliance & Quality Standards
Compliance with international regulatory standards is paramount for Glenmark's export success. The company has consistently adhered to guidelines set by the US FDA, WHO, and EU GMP, ensuring the quality and safety of its products. Notably, Glenmark's manufacturing facilities have undergone rigorous inspections, reflecting its commitment to maintaining high-quality standards.
The evolving regulatory landscape, including the EU's Falsified Medicines Directive, necessitates continuous adaptation. Glenmark's proactive approach to compliance positions it well to navigate these changes, thereby sustaining its market access and reputation.
About Glenmark Pharmaceuticals Limited
Glenmark Pharmaceuticals Limited exports 28 products worth $205.5M. Beyond Sirolimus, top products include Rosuvastatin, Omeprazole, Gabapentin, Ondansetron, Naproxen. View the complete Glenmark Pharmaceuticals Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Sirolimus — 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: Sirolimus shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Glenmark Pharmaceuticals 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 32 individual customs records matching Glenmark Pharmaceuticals Limited exporting Sirolimus, covering 18 formulations to 3 countries via 3 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 48+ countries, 128+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Sirolimus Export Data from Glenmark Pharmaceuticals Limited
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Glenmark Pharmaceuticals Limited
Full Company Profile →
28 products · $205.5M total trade · 14 categories
Sirolimus 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 Sirolimus. For current shipment-level data, contact TransData Nexus.