Intas Pharmaceuticals Limited — Mycophenolate Exporter Profile
Indian Pharmaceutical Exporter · #1 for Mycophenolate · $23.4M export value · DGFT Verified
Intas Pharmaceuticals Limited is the #1 Indian exporter of Mycophenolate with $23.4M in export value and 454 verified shipments. Intas Pharmaceuticals Limited holds a 6.8% market share in Mycophenolate exports across 24 countries. The company exports 75 pharmaceutical products worth $372.3M across 19 therapeutic categories.
Intas Pharmaceuticals Limited — Mycophenolate Export Profile: Buyers & Destinations
Where Does Intas Pharmaceuticals Limited Export Mycophenolate?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $7.3M | 158 | 46.0% |
| BRAZIL | $1.6M | 36 | 9.9% |
| THAILAND | $1.6M | 40 | 9.9% |
| AUSTRALIA | $1.1M | 31 | 6.9% |
| POLAND | $779.4K | 22 | 4.9% |
| NETHERLANDS | $664.0K | 37 | 4.2% |
| UNITED KINGDOM | $626.2K | 34 | 3.9% |
| CANADA | $607.5K | 16 | 3.8% |
| ITALY | $386.5K | 18 | 2.4% |
| GERMANY | $332.7K | 10 | 2.1% |
Intas Pharmaceuticals Limited exports Mycophenolate to 26 countries. The largest destination is UNITED STATES accounting for 46.0% of Intas Pharmaceuticals Limited's Mycophenolate shipments, followed by BRAZIL (9.9%) and THAILAND (9.9%). These destinations reflect Intas Pharmaceuticals Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Mycophenolate from Intas Pharmaceuticals Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| EVERSANA LIFE SCIENCES SERVICES,LLC | UNITED STATES | $4.6M | 98 |
| EVERSANA LIFE SCIENCES SERVICES LLC | UNITED STATES | $1.4M | 29 |
| TO THE ORDER | NETHERLANDS | $998.6K | 44 |
| EVERSANA LIFE SCIENCES SERVICESLLC | UNITED STATES | $945.1K | 21 |
| ACCORD FARMACUTICA LTDA | BRAZIL | $900.9K | 19 |
| BERLIN PHARMACEUTICALINDUSTRYCO.LTD | THAILAND | $597.7K | 13 |
| BERLIN PHARMACEUTICAL INDUSTRY CO.L | THAILAND | $446.9K | 9 |
| APOTEX PTY LTD | AUSTRALIA | $410.8K | 10 |
| ACCORD UK | UNITED KINGDOM | $390.9K | 20 |
| ACCORD HEALTHCARE POLSKA SP ZOO MAGAZYN IMPORTERA UL LUTOMIERSKA | POLAND | $376.0K | 9 |
Intas Pharmaceuticals Limited supplies Mycophenolate to 70 buyers globally. The largest buyer is EVERSANA LIFE SCIENCES SERVICES,LLC (UNITED STATES), followed by EVERSANA LIFE SCIENCES SERVICES LLC (UNITED STATES) and TO THE ORDER (NETHERLANDS). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Mycophenolate Export Value and How Much Does Intas Pharmaceuticals Limited Contribute?
India exported $86.9M worth of Mycophenolate through 2,529 shipments from 167 suppliers to 100 countries, serving 512 buyers globally. Intas Pharmaceuticals Limited contributes $23.4M to this total, accounting for 6.8% of India's Mycophenolate exports. Intas Pharmaceuticals Limited ships Mycophenolate to 26 countries through 70 buyers.
What Is the Average Shipment Value for Intas Pharmaceuticals Limited's Mycophenolate Exports?
Intas Pharmaceuticals Limited's average Mycophenolate shipment value is $51.5K per consignment, based on 454 shipments totaling $23.4M. The largest destination is UNITED STATES (46.0% of Intas Pharmaceuticals Limited's Mycophenolate exports).
How Does Intas Pharmaceuticals Limited Compare to Other Indian Mycophenolate Exporters?
Intas Pharmaceuticals Limited ranks #1 among 167 Indian Mycophenolate exporters with a 6.8% market share. The top 3 exporters are INTAS PHARMACEUTICALS LIMITED ($22.7M), ALKEM LABORATORIES LIMITED ($17.8M), EMCURE PHARMACEUTICALS LIMITED ($14.0M). Intas Pharmaceuticals Limited processed 454 shipments to 24 destination countries.
What Mycophenolate Formulations Does Intas Pharmaceuticals Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| PHARMA DRUGS AND MEDI MYCOPHENOLATE MOFE | $639.4K | 14 |
| PHARMA DRUGS & MEDI MYCOPHENOLATE MOFETIL USP 500MG500T(US) AS PER INVOICE | $498.8K | 11 |
| PHA.DRU & MEDI, MYCOPHENOLATE MOF CAP US | $487.9K | 11 |
| PHA.DRU & MEDI, MYCOPHENOLATE MOFETIL USP 500MG500T(US) MYCOPHENOLATE MOFETIL T 500MG EACH FILM COATED TABLET | $414.9K | 11 |
| PHARMA DRUGS & MEDI MYCOPHENOLATE MOFETI | $400.0K | 8 |
| PHR DRUGS&MEDI MYCOPHENOLATE MOFETIL USP | $400.0K | 8 |
| PHA.DRU & MEDI, MYCOPHENOLATE MOFETIL US | $385.7K | 8 |
| PHARMA DRUGS & MEDI MYCOPHENOLATE MOF CA | $300.0K | 6 |
| PHR DRUGS & MEDI MYCOPHEN ACID USP DR360MG 1X120T ACC-US EACH DELAYED RELEASE TABLET CONTAINS MYCOPHENOLATE SODIUM, USP | $300.0K | 6 |
| PHARM DRUG&MED:MYCOPHENOLIC ACID 360MG-(ACCO-BRZ)-5X10T EACH DELAYED RELEASE COATED TABLET CONT:MYCOPHENOLATE (ASPERINV) | $300.0K | 6 |
Intas Pharmaceuticals Limited exports 220 distinct Mycophenolate formulations including tablets, capsules, syrups, and combination drugs. The top formulation is PHARMA DRUGS AND MEDI MYCOPHENOLATE MOFE with 14 shipments worth $639.4K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Mycophenolate to Key Markets
What Intas Pharmaceuticals Limited must comply with to export Mycophenolate 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 Intas Pharmaceuticals Limited Compare to Nearest Mycophenolate Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | INTAS PHARMACEUTICALS LIMITED ★ | $22.7M | 454 | 24 | $50.0K |
| 3 | ALKEM LABORATORIES LIMITED | $17.8M | 356 | 9 | $50.0K |
| 5 | EMCURE PHARMACEUTICALS LIMITED | $14.0M | 299 | 23 | $46.7K |
Intas Pharmaceuticals Limited ranks #1 among 167 Indian Mycophenolate exporters. Average shipment value of $50.0K compared to the market average of $520.1K. The closest competitors by value are ALKEM LABORATORIES LIMITED and EMCURE PHARMACEUTICALS LIMITED.
Which Indian Ports Ship Mycophenolate Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 464 | 18.3% |
| NHAVA SHEVA SEA (INNSA1) | 308 | 12.2% |
| SAHAR AIR CARGO ACC (INBOM4) | 229 | 9.1% |
| JNPT/ NHAVA SHEVA SEA | 135 | 5.3% |
| DELHI AIR | 115 | 4.5% |
| AHEMDABAD AIR ACC (INAMD4) | 108 | 4.3% |
| MUNDRA SEA | 97 | 3.8% |
| BANGALORE ICD | 97 | 3.8% |
What Other Immunosuppressants Products Does Intas Pharmaceuticals Limited Export?
Intas Pharmaceuticals Limited also exports these immunosuppressants products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Intas Pharmaceuticals Limited's Mycophenolate 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 Mycophenolate, top products include Ras, Tacrolimus, Apixaban, Ezetimibe, Iron. View the complete Intas Pharmaceuticals Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Mycophenolate — 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: Mycophenolate 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 468 individual customs records matching Intas Pharmaceuticals Limited exporting Mycophenolate, covering 220 formulations to 26 countries via 70 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 100+ countries, 512+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Mycophenolate 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
Mycophenolate 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 Mycophenolate. For current shipment-level data, contact TransData Nexus.