Intas Pharmaceuticals Limited — Busulfan Exporter Profile
Indian Pharmaceutical Exporter · #1 for Busulfan · $2.0M export value · DGFT Verified
Intas Pharmaceuticals Limited is the #1 Indian exporter of Busulfan with $2.0M in export value and 92 verified shipments. Intas Pharmaceuticals Limited holds a 40.4% market share in Busulfan exports across 15 countries. The company exports 75 pharmaceutical products worth $372.3M across 19 therapeutic categories.
Intas Pharmaceuticals Limited — Busulfan Export Profile: Buyers & Destinations
Where Does Intas Pharmaceuticals Limited Export Busulfan?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $457.7K | 12 | 33.3% |
| UNITED KINGDOM | $202.7K | 10 | 14.7% |
| POLAND | $158.6K | 6 | 11.5% |
| PERU | $130.2K | 3 | 9.5% |
| NETHERLANDS | $99.7K | 15 | 7.3% |
| SOUTH AFRICA | $80.6K | 4 | 5.9% |
| BRAZIL | $66.0K | 3 | 4.8% |
| THAILAND | $65.5K | 4 | 4.8% |
| AUSTRALIA | $36.5K | 1 | 2.7% |
| SPAIN | $27.9K | 4 | 2.0% |
Intas Pharmaceuticals Limited exports Busulfan to 15 countries. The largest destination is UNITED STATES accounting for 33.3% of Intas Pharmaceuticals Limited's Busulfan shipments, followed by UNITED KINGDOM (14.7%) and POLAND (11.5%). These destinations reflect Intas Pharmaceuticals Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Busulfan from Intas Pharmaceuticals Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| EVERSANA LIFE SCIENCES SERVICES,LLC | UNITED STATES | $179.8K | 6 |
| ACCORD UK | UNITED KINGDOM | $111.6K | 7 |
| ACCORD HEALTHCARE S.A.C. | PERU | $100.0K | 2 |
| MYLAN INSTITUTIONAL INC GSO | UNITED STATES | $100.0K | 2 |
| ACCORD HEALTHCARE POLSKA SP Z O O | POLAND | $100.0K | 2 |
| TO THE ORDER | UNITED KINGDOM | $93.4K | 2 |
| EVERSANA LIFE SCIENCES SERVICES,LL | UNITED STATES | $80.4K | 2 |
| ACCORD FARMACEUTICA LTDA | BRAZIL | $66.0K | 3 |
| ACCORD HEALTHCARE C/O QESTMED (PTY) | SOUTH AFRICA | $59.9K | 2 |
| ACCORD HEALTHCARE THAILAND LTD | THAILAND | $58.6K | 2 |
Intas Pharmaceuticals Limited supplies Busulfan to 35 buyers globally. The largest buyer is EVERSANA LIFE SCIENCES SERVICES,LLC (UNITED STATES), followed by ACCORD UK (UNITED KINGDOM) and ACCORD HEALTHCARE S.A.C. (PERU). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Busulfan Export Value and How Much Does Intas Pharmaceuticals Limited Contribute?
India exported $4.7M worth of Busulfan through 369 shipments from 33 suppliers to 44 countries, serving 109 buyers globally. Intas Pharmaceuticals Limited contributes $2.0M to this total, accounting for 40.4% of India's Busulfan exports. Intas Pharmaceuticals Limited ships Busulfan to 15 countries through 35 buyers.
What Is the Average Shipment Value for Intas Pharmaceuticals Limited's Busulfan Exports?
Intas Pharmaceuticals Limited's average Busulfan shipment value is $21.7K per consignment, based on 92 shipments totaling $2.0M. The largest destination is UNITED STATES (33.3% of Intas Pharmaceuticals Limited's Busulfan exports).
How Does Intas Pharmaceuticals Limited Compare to Other Indian Busulfan Exporters?
Intas Pharmaceuticals Limited ranks #1 among 33 Indian Busulfan exporters with a 40.4% market share. The top 3 exporters are INTAS PHARMACEUTICALS LIMITED ($2.0M), EMCURE PHARMACEUTICALS LIMITED ($1.5M), FRESENIUS KABI ONCOLOGY LIMITED ($627.6K). Intas Pharmaceuticals Limited processed 92 shipments to 15 destination countries.
What Busulfan Formulations Does Intas Pharmaceuticals Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| PHA.DRU & MEDI, BUSULFAN INJECTION 6MG/M | $114.9K | 3 |
| PH.DRU. & MED.: BUFANCORD (BUSULFAN CONC | $100.0K | 2 |
| BUSULFAN INJ 6MG/ML 10ML 1X8V MYLAN USA | $100.0K | 2 |
| PHARMA DRUGS & MEDI BUSULFAN INJ,6MG/ML,10MLX1VACCORD-PL/RO AS PER DOCUMENT | $100.0K | 2 |
| PHARMA DRUG&MED:BUSULFAN INJ,6MG/ML,10ML | $98.6K | 8 |
| PHARMA DRUGS & MEDI BUSULFAN INJ,6MG/ML, | $66.6K | 8 |
| PHR DRUGS & MEDI ACCORAN BUSULFAN 6MG/ML | $59.9K | 2 |
| PHARMA DRUG&MED: BUSSULFANO 60MG/10ML,10ML 1V (AC-BR)EACH ML CONTAINS: BUSULFANPH.EUR. 6MG COLOUR N.A.VLS | $50.0K | 1 |
| PHA.DRU & MEDI BUSULFAN INJECTION6MG/ML10ML8V(ACC-US EACH ML CONTAINS BUSULFAN USP 6 MG 1239X1X8VIAL | $50.0K | 1 |
| PHARMA DRUGS AND MEDI BUSULFAN INJECTION6MG/ML,10ML8V(ACC-US) BUSULFAN USP 6 MG | $47.5K | 1 |
Intas Pharmaceuticals Limited exports 64 distinct Busulfan formulations including tablets, capsules, syrups, and combination drugs. The top formulation is PHA.DRU & MEDI, BUSULFAN INJECTION 6MG/M with 3 shipments worth $114.9K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Busulfan to Key Markets
What Intas Pharmaceuticals Limited must comply with to export Busulfan 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.
United Kingdom — MHRA
Approval Process
Post-Brexit UK Marketing Authorisation via national procedure. Separate from EU approval since January 2021.
Timeline: 12–15 months
GMP & Export Requirements
UK GMP compliance; MHRA inspection of manufacturing site
Manufacturer Import Authorisation (MIA) held by UK importer; Qualified Person (QP) batch release
Note: Post-Brexit: EU GMP certificates no longer automatically valid in UK. Separate MHRA recognition required.
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 Intas Pharmaceuticals Limited Compare to Nearest Busulfan Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | INTAS PHARMACEUTICALS LIMITED ★ | $2.0M | 92 | 15 | $21.7K |
| 2 | EMCURE PHARMACEUTICALS LIMITED | $1.5M | 109 | 9 | $14.1K |
| 3 | FRESENIUS KABI ONCOLOGY LIMITED | $627.6K | 77 | 7 | $8.2K |
Intas Pharmaceuticals Limited ranks #1 among 33 Indian Busulfan exporters. Average shipment value of $21.7K compared to the market average of $143.5K. The closest competitors by value are EMCURE PHARMACEUTICALS LIMITED and FRESENIUS KABI ONCOLOGY LIMITED.
Which Indian Ports Ship Busulfan Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR CARGO ACC (INBOM4) | 75 | 20.3% |
| SAHAR AIR | 62 | 16.8% |
| DELHI AIR | 41 | 11.1% |
| DELHI AIR CARGO ACC (INDEL4) | 31 | 8.4% |
| AHEMDABAD AIR ACC (INAMD4) | 26 | 7.0% |
| AHEMDABAD AIR | 21 | 5.7% |
| MUNDRA SEA (INMUN1) | 17 | 4.6% |
| Ahmedabad Air | 13 | 3.5% |
Geopolitical & Trade Policy Impact on Intas Pharmaceuticals Limited's Busulfan Exports
The current geopolitical landscape presents both challenges and opportunities for Indian pharmaceutical exporters like Intas Pharmaceuticals. The Israel-Iran tensions have led to increased security risks in the Strait of Hormuz and the Red Sea–Suez Canal corridor, prompting major carriers to reroute shipments around the Cape of Good Hope. This detour has extended transit times by 10–20 days and raised freight rates by 40–50% on key India–Europe routes, impacting the cost-effectiveness and timeliness of exports. (livemint.com)
Conversely, the ongoing US-China trade tensions have opened avenues for Indian pharmaceutical companies to capture a larger share of the U.S. market. Intas's acquisition of UDENYCA® and the FDA's acceptance of its biosimilar applications position the company to leverage these opportunities effectively. However, compliance with the European Union's Falsified Medicines Directive (FMD) remains a critical factor for market access. Intas's proactive approach in securing partnerships and ensuring regulatory compliance underscores its commitment to maintaining and expanding its presence in the European market.
Intas Pharmaceuticals Limited — Regulatory Compliance & Quality Standards
Maintaining stringent regulatory compliance is paramount for Indian pharmaceutical exporters. Intas Pharmaceuticals has demonstrated a strong commitment to adhering to international quality standards, as evidenced by its successful acquisitions and partnerships that necessitate compliance with FDA, WHO, and EU Good Manufacturing Practices (GMP). The company's proactive engagement in regulatory processes, such as the FDA's acceptance of its Biologics License Application for DMB-3115, reflects its dedication to quality and compliance. (intaspharma.com) As global regulatory requirements continue to evolve, Intas's focus on quality assurance and compliance positions it favorably in the competitive pharmaceutical export market.
About Intas Pharmaceuticals Limited
Intas Pharmaceuticals Limited exports 75 products worth $372.3M. Beyond Busulfan, top products include Ras, Mycophenolate, Tacrolimus, Apixaban, Ezetimibe. View the complete Intas Pharmaceuticals Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Busulfan — 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: Busulfan shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Intas 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 108 individual customs records matching Intas Pharmaceuticals Limited exporting Busulfan, covering 64 formulations to 15 countries via 35 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 44+ countries, 109+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Busulfan Export Data from Intas Pharmaceuticals Limited
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Intas Pharmaceuticals Limited
Full Company Profile →
75 products · $372.3M total trade · 19 categories
Busulfan 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 Busulfan. For current shipment-level data, contact TransData Nexus.