Intas Pharmaceuticals Limited — Mitomycin Exporter Profile
Indian Pharmaceutical Exporter · #1 for Mitomycin · $2.3M export value · DGFT Verified
Intas Pharmaceuticals Limited is the #1 Indian exporter of Mitomycin with $2.3M in export value and 46 verified shipments. Intas Pharmaceuticals Limited holds a 28.2% market share in Mitomycin exports across 6 countries. The company exports 75 pharmaceutical products worth $372.3M across 19 therapeutic categories.
Intas Pharmaceuticals Limited — Mitomycin Export Profile: Buyers & Destinations
Where Does Intas Pharmaceuticals Limited Export Mitomycin?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.0M | 34 | 70.4% |
| JAPAN | $204.6K | 6 | 14.3% |
| UNITED KINGDOM | $50.0K | 1 | 3.5% |
| CANADA | $50.0K | 1 | 3.5% |
| POLAND | $50.0K | 1 | 3.5% |
| FRANCE | $39.0K | 1 | 2.7% |
| AUSTRALIA | $26.8K | 1 | 1.9% |
| MALTA | $3.5K | 2 | 0.2% |
| ITALY | $117 | 5 | 0.0% |
| HUNGARY | $12 | 1 | 0.0% |
Intas Pharmaceuticals Limited exports Mitomycin to 10 countries. The largest destination is UNITED STATES accounting for 70.4% of Intas Pharmaceuticals Limited's Mitomycin shipments, followed by JAPAN (14.3%) and UNITED KINGDOM (3.5%). These destinations reflect Intas Pharmaceuticals Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Mitomycin from Intas Pharmaceuticals Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| EVERSANA LIFE SCIENCES SERVICES,LLC | UNITED STATES | $290.9K | 15 |
| TO THE ORDER | UNITED STATES | $200.0K | 4 |
| B BRAUN MEDICAL INC | UNITED STATES | $150.0K | 3 |
| FOUNDATION CARE | UNITED STATES | $150.0K | 3 |
| KYOWA KIRIN CO LTD | JAPAN | $120.0K | 3 |
| FOUNDATION CARE. | UNITED STATES | $118.4K | 3 |
| XXOWAXXIRIXXCO XXLIMITEDX | JAPAN | $67.3K | 2 |
| XXCORXXHEAXXHCAXX LTXX | UNITED KINGDOM | $51.2K | 2 |
| ACCORD HEALTHCARE INC | CANADA | $50.0K | 1 |
| ACCORD HEALTHCARE POLSKA SP Z O O | POLAND | $50.0K | 1 |
Intas Pharmaceuticals Limited supplies Mitomycin to 19 buyers globally. The largest buyer is EVERSANA LIFE SCIENCES SERVICES,LLC (UNITED STATES), followed by TO THE ORDER (UNITED STATES) and B BRAUN MEDICAL INC (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Mitomycin Export Value and How Much Does Intas Pharmaceuticals Limited Contribute?
India exported $5.6M worth of Mitomycin through 1,333 shipments from 213 suppliers to 103 countries, serving 456 buyers globally. Intas Pharmaceuticals Limited contributes $2.3M to this total, accounting for 28.2% of India's Mitomycin exports. Intas Pharmaceuticals Limited ships Mitomycin to 10 countries through 19 buyers.
What Is the Average Shipment Value for Intas Pharmaceuticals Limited's Mitomycin Exports?
Intas Pharmaceuticals Limited's average Mitomycin shipment value is $50.0K per consignment, based on 46 shipments totaling $2.3M. The largest destination is UNITED STATES (70.4% of Intas Pharmaceuticals Limited's Mitomycin exports).
How Does Intas Pharmaceuticals Limited Compare to Other Indian Mitomycin Exporters?
Intas Pharmaceuticals Limited ranks #1 among 213 Indian Mitomycin exporters with a 28.2% market share. The top 3 exporters are INTAS PHARMACEUTICALS LIMITED ($2.3M), MYLAN LABORATORIES LIMITED ($1.3M), NAPROD LIFE SCIENCES PRIVATE LIMITED ($738.6K). Intas Pharmaceuticals Limited processed 46 shipments to 6 destination countries.
What Mitomycin Formulations Does Intas Pharmaceuticals Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| PHAR.DRUGS AND MED: MITOSOL 0.2MG/VIAL EYEDROP (MOBI-USA Mitomycin for Solution0.2MG EACH VIAL CONTAINS : MITOMYICIN US | $200.0K | 4 |
| PH.DRU.& MED.: MITOSOL 0.2MG/VIAL EYE DROP (MITOMYCIN FOR OPHTHALMIC SOLUTION 0.2MG/VIAL EACH VIAL CONT. MITOMYCIN USP 0 | $168.4K | 4 |
| PH.DRU.& MED.: MITOSOL 0.2MG/VIAL EYE DROP MITOMYCIN FOR OPHTHALMIC SOLUTION 0.2MG/VIAL EACH VIAL CONT. MITOMYCIN USP 0 | $150.0K | 3 |
| PHR DRUGS&MEDI MITOMYCIN FOR INJ USP 5MG | $124.8K | 6 |
| PHA.DRU & MEDI, MITOSOL 0.2MG/VIALEYEDROP (MOBI-USA Mitomycin for Solution 0.2MG EACH VIAL CONTAINS : MITOMY | $100.0K | 2 |
| PHARMA DRUGS & MEDI MITOMYCIN FOR INJ US | $96.9K | 5 |
| MITOMYCIN POWD FOR SOL 2MG/VIALKKC-JP | $87.3K | 3 |
| MITOMYCIN POWD FOR SOL 2MG/VIAL(KKC-JP) | $67.3K | 2 |
| MITOMYCIN POWDER 10MG/VIAL 1V | $51.2K | 2 |
| MITOMYCIN 20MG/V 1X1V ACC-CAN | $50.0K | 1 |
Intas Pharmaceuticals Limited exports 30 distinct Mitomycin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is PHAR.DRUGS AND MED: MITOSOL 0.2MG/VIAL EYEDROP (MOBI-USA Mit with 4 shipments worth $200.0K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Mitomycin to Key Markets
What Intas Pharmaceuticals Limited must comply with to export Mitomycin 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.
Japan — PMDA
Approval Process
Generic Drug Application per Japan Pharmaceutical Affairs Act. Dissolution and bioequivalence studies per PMDA guidelines. Japanese data bridging often required.
Timeline: 12–24 months
GMP & Export Requirements
Japanese GMP (J-GMP); PMDA on-site inspection of Indian manufacturing facility
Foreign Manufacturer Accreditation from PMDA; Japanese MAH (Marketing Authorization Holder) partner required
Note: Japan requires Yen-denominated NHI drug price listing. Stability data under ICH Zone IVb conditions.
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 Mitomycin Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | INTAS PHARMACEUTICALS LIMITED ★ | $2.3M | 46 | 6 | $50.0K |
| 2 | MYLAN LABORATORIES LIMITED | $1.3M | 25 | 1 | $50.0K |
| 3 | NAPROD LIFE SCIENCES PRIVATE LIMITED | $738.6K | 19 | 3 | $38.9K |
Intas Pharmaceuticals Limited ranks #1 among 213 Indian Mitomycin exporters. Average shipment value of $50.0K compared to the market average of $26.4K. The closest competitors by value are MYLAN LABORATORIES LIMITED and NAPROD LIFE SCIENCES PRIVATE LIMITED.
Which Indian Ports Ship Mitomycin Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 341 | 25.6% |
| SAHAR AIR CARGO ACC (INBOM4) | 261 | 19.6% |
| Bombay Air | 104 | 7.8% |
| DELHI AIR | 91 | 6.8% |
| DELHI AIR CARGO ACC (INDEL4) | 72 | 5.4% |
| AHEMDABAD AIR ACC (INAMD4) | 62 | 4.7% |
| AHEMDABAD AIR | 55 | 4.1% |
| Bombay Air Cargo | 43 | 3.2% |
Geopolitical & Trade Policy Impact on Intas Pharmaceuticals Limited's Mitomycin 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 Mitomycin, 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 Mitomycin — 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: Mitomycin 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 53 individual customs records matching Intas Pharmaceuticals Limited exporting Mitomycin, covering 30 formulations to 10 countries via 19 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 103+ countries, 456+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Mitomycin Export Data from Intas Pharmaceuticals Limited
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Intas Pharmaceuticals Limited
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75 products · $372.3M total trade · 19 categories
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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 Mitomycin. For current shipment-level data, contact TransData Nexus.