Alkem Laboratories Limited — Sirolimus Exporter Profile
Indian Pharmaceutical Exporter · #2 for Sirolimus · $2.9M export value · DGFT Verified
Alkem Laboratories Limited is the #2 Indian exporter of Sirolimus with $2.9M in export value and 54 verified shipments. Alkem Laboratories Limited holds a 18.1% market share in Sirolimus exports across 2 countries. The company exports 30 pharmaceutical products worth $247.0M across 15 therapeutic categories.
Alkem Laboratories Limited — Sirolimus Export Profile: Buyers & Destinations
Where Does Alkem Laboratories Limited Export Sirolimus?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $2.3M | 53 | 98.5% |
| CHILE | $36.3K | 5 | 1.5% |
Alkem Laboratories Limited exports Sirolimus to 2 countries. The largest destination is UNITED STATES accounting for 98.5% of Alkem Laboratories Limited's Sirolimus shipments. These destinations reflect Alkem Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Sirolimus from Alkem Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| ASCEND LABORATORIES,LLC | UNITED STATES | $1.6M | 36 |
| ASCEND LABORATORIES LLC | UNITED STATES | $460.6K | 11 |
| ASCEND LABORATORIESLLC | UNITED STATES | $113.0K | 3 |
| ASCEND LABORATORIES, LLC, | UNITED STATES | $102.8K | 3 |
| ASCEND LABORATORIES SPA | CHILE | $36.3K | 5 |
Alkem Laboratories Limited supplies Sirolimus to 5 buyers globally. The largest buyer is ASCEND LABORATORIES,LLC (UNITED STATES), followed by ASCEND LABORATORIES LLC (UNITED STATES) and ASCEND LABORATORIESLLC (UNITED STATES). 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 Alkem Laboratories Limited Contribute?
India exported $6.1M worth of Sirolimus through 1,244 shipments from 97 suppliers to 48 countries, serving 128 buyers globally. Alkem Laboratories Limited contributes $2.9M to this total, accounting for 18.1% of India's Sirolimus exports. Alkem Laboratories Limited ships Sirolimus to 2 countries through 5 buyers.
What Is the Average Shipment Value for Alkem Laboratories Limited's Sirolimus Exports?
Alkem Laboratories Limited's average Sirolimus shipment value is $53.7K per consignment, based on 54 shipments totaling $2.9M. The largest destination is UNITED STATES (98.5% of Alkem Laboratories Limited's Sirolimus exports).
How Does Alkem Laboratories Limited Compare to Other Indian Sirolimus Exporters?
Alkem Laboratories Limited ranks #2 among 97 Indian Sirolimus exporters with a 18.1% market share. The top 3 exporters are ALKEM LABORATORIES LIMITED ($2.7M), ZYDUS LIFESCIENCES LIMITED ($1.6M), DR REDDYS LABORATORIES LIMITED ($400.0K). Alkem Laboratories Limited processed 54 shipments to 2 destination countries.
What Sirolimus Formulations Does Alkem Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| PHARMACEUTICAL PRODUCTS : SIROLIMUS TABLETS 1MG (100'S) USA NDC No67877074701 | $244.7K | 5 |
| SIROLIMUS TABLETS 1 MG (100S) USA, NDC | $231.9K | 5 |
| PHARMACEUTICAL PRODUCTS: SIROLIMUS TABLE | $200.0K | 4 |
| PHARMACEUTICAL PRODUCTS : SIROLIMUS TABLETS 0.5MG (100'S) USA NDC No67877074601 | $150.0K | 3 |
| SIROLIMUS TABLETS 1 MG (100'S) USA, NDC NO.: 67877074701 . | $150.0K | 3 |
| SIROLIMUS TABLETS 0.5MG (100S) USA NDC | $108.8K | 3 |
| PHARMACEUTICAL PRODUCTS :SIROLIMUS TABLE | $100.0K | 2 |
| PHARMACEUTICAL PRODUCTS : SIROLIMUS TABLETS 2MG (100'S) USA NDC No67877074801 | $100.0K | 2 |
| SIROLIMUS TABLETS 0.5MG (100'S) USA NDC NO67877074601 | $100.0K | 2 |
| PHARMACEUTICAL PRODUCTS- SIROLIMUS TAB | $85.2K | 2 |
Alkem Laboratories Limited exports 30 distinct Sirolimus formulations including tablets, capsules, syrups, and combination drugs. The top formulation is PHARMACEUTICAL PRODUCTS : SIROLIMUS TABLETS 1MG (100'S) USA with 5 shipments worth $244.7K.
Regulatory Requirements: Exporting Sirolimus to Key Markets
What Alkem Laboratories 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.
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 Alkem Laboratories Limited Compare to Nearest Sirolimus Exporters?
Exporters ranked immediately above and below #2 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | ALKEM LABORATORIES LIMITED ★ | $2.7M | 54 | 2 | $50.0K |
| 1 | ZYDUS LIFESCIENCES LIMITED | $1.6M | 32 | 2 | $50.0K |
| 4 | DR REDDYS LABORATORIES LIMITED | $400.0K | 8 | 1 | $50.0K |
Alkem Laboratories Limited ranks #2 among 97 Indian Sirolimus exporters. Average shipment value of $50.0K compared to the market average of $62.9K. The closest competitors by value are ZYDUS LIFESCIENCES LIMITED and DR REDDYS LABORATORIES 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 Alkem Laboratories Limited Export?
Alkem Laboratories Limited also exports these immunosuppressants products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Alkem Laboratories Limited's Sirolimus Exports
The current geopolitical climate presents both challenges and opportunities for Indian pharmaceutical exporters like Alkem Laboratories. Escalating tensions in the Red Sea region, particularly due to Houthi attacks, have disrupted traditional shipping routes, leading to increased freight costs and extended delivery timelines. Major carriers have rerouted vessels around the Cape of Good Hope, adding 10–20 days to transit times and raising freight rates by 40–50% on key India–Europe routes (livemint.com). This logistical upheaval necessitates strategic adjustments in supply chain management to mitigate delays and cost escalations.
Conversely, the ongoing US-China trade tensions have prompted the United States to diversify its pharmaceutical supply sources, potentially benefiting Indian exporters. Alkem's established presence in the US market positions it to capitalize on this shift, provided it maintains stringent compliance with US regulatory standards. Additionally, the recent India–European Union Free Trade Agreement, signed in January 2026, aims to eliminate tariffs on pharmaceuticals, enhancing the competitiveness of Indian exporters in the EU market (en.wikipedia.org). However, compliance with the EU's Falsified Medicines Directive remains imperative to ensure market access.
Alkem Laboratories Limited — Regulatory Compliance & Quality Standards
Regulatory compliance is paramount for sustaining export operations in stringent markets like the US and EU. Alkem's subsidiary, Enzene Biosciences, recently underwent a USFDA inspection at its Chakan facility, resulting in six procedural observations but no data integrity issues (m.economictimes.com). This outcome underscores the company's commitment to quality assurance and regulatory adherence. Continuous investment in compliance infrastructure and proactive engagement with regulatory bodies are essential for Alkem to navigate the evolving global regulatory landscape effectively.
About Alkem Laboratories Limited
Alkem Laboratories Limited exports 30 products worth $247.0M. Beyond Sirolimus, top products include Amlodipine, Cephalexin, Gabapentin, Ezetimibe, Mycophenolate. View the complete Alkem Laboratories 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: Alkem Laboratories 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 58 individual customs records matching Alkem Laboratories Limited exporting Sirolimus, covering 30 formulations to 2 countries via 5 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 Alkem Laboratories Limited
Access shipment-level details, pricing data, buyer connections, and competitive analysis for Alkem Laboratories Limited's Sirolimus exports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
Alkem Laboratories Limited
Full Company Profile →
30 products · $247.0M total trade · 15 categories
Sirolimus Stats
Company Overview
Top Products by Alkem Laboratories Limited
Related Analysis
Need Detailed Export Data?
Access shipment-level records, pricing trends, and buyer contacts for Alkem Laboratories Limited.
Request DemoView Pricing →Data Source
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.