Steriscience Specialties Private Limited — Ampicillin Exporter Profile
Indian Pharmaceutical Exporter · #2 for Ampicillin · $12.9M export value · DGFT Verified
Steriscience Specialties Private Limited is the #2 Indian exporter of Ampicillin with $12.9M in export value and 259 verified shipments. Steriscience Specialties Private Limited holds a 9.1% market share in Ampicillin exports across 3 countries. The company exports 4 pharmaceutical products worth $23.8M across 4 therapeutic categories.
Steriscience Specialties Private Limited — Ampicillin Export Profile: Buyers & Destinations
Where Does Steriscience Specialties Private Limited Export Ampicillin?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $7.7M | 159 | 68.7% |
| BRAZIL | $2.0M | 54 | 18.0% |
| AUSTRALIA | $1.5M | 46 | 13.3% |
Steriscience Specialties Private Limited exports Ampicillin to 3 countries. The largest destination is UNITED STATES accounting for 68.7% of Steriscience Specialties Private Limited's Ampicillin shipments, followed by BRAZIL (18.0%) and AUSTRALIA (13.3%). These destinations reflect Steriscience Specialties Private Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Ampicillin from Steriscience Specialties Private Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| ARMAS PHARMACEUTICALS | UNITED STATES | $6.6M | 135 |
| MYLAN BRASIL DISTRIBUIDORA | BRAZIL | $1.2M | 33 |
| MYLAN INSTITUTIONAL INC | UNITED STATES | $1.1M | 24 |
| ALPHAPHARMA PTY LTD | AUSTRALIA | $531.6K | 17 |
| MYLAN BRASIL DISTRIBUIDORA DE | BRAZIL | $447.4K | 12 |
| ALPHAPHARM PTY LTD | AUSTRALIA | $409.5K | 18 |
| ALPHAPHARM PTY LIMITED | AUSTRALIA | $350.0K | 7 |
| MYLAN BRASIL DISTRIBUIDORA DE MEDICAMENTOS LIMITED | BRAZIL | $186.1K | 4 |
| MYLAN BRASIL DISTRIBUIDORA DE MEDICAMENTOS LTD | BRAZIL | $180.4K | 5 |
| ALPHAPHARM PTY LTD. | AUSTRALIA | $150.0K | 3 |
Steriscience Specialties Private Limited supplies Ampicillin to 11 buyers globally. The largest buyer is ARMAS PHARMACEUTICALS (UNITED STATES), followed by MYLAN BRASIL DISTRIBUIDORA (BRAZIL) and MYLAN INSTITUTIONAL INC (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Ampicillin Export Value and How Much Does Steriscience Specialties Private Limited Contribute?
India exported $52.7M worth of Ampicillin through 4,470 shipments from 486 suppliers to 133 countries, serving 924 buyers globally. Steriscience Specialties Private Limited contributes $12.9M to this total, accounting for 9.1% of India's Ampicillin exports. Steriscience Specialties Private Limited ships Ampicillin to 3 countries through 11 buyers.
What Is the Average Shipment Value for Steriscience Specialties Private Limited's Ampicillin Exports?
Steriscience Specialties Private Limited's average Ampicillin shipment value is $50.0K per consignment, based on 259 shipments totaling $12.9M. The largest destination is UNITED STATES (68.7% of Steriscience Specialties Private Limited's Ampicillin exports).
How Does Steriscience Specialties Private Limited Compare to Other Indian Ampicillin Exporters?
Steriscience Specialties Private Limited ranks #2 among 486 Indian Ampicillin exporters with a 9.1% market share. The top 3 exporters are STERISCIENCE SPECIALTIES PRIVATE LIMITED ($12.9M), SPARSH BIO-TECH PRIVATE LIMITED ($10.4M), AUROBINDO PHARMA LTD ($4.7M). Steriscience Specialties Private Limited processed 259 shipments to 3 destination countries.
What Ampicillin Formulations Does Steriscience Specialties Private Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| AMPICILLIN AND SULBACTAM FOR INJECTION U | $1.5M | 39 |
| AMPICILLIN & SULBACTAM FOR INJECTION USP | $481.0K | 10 |
| AMPICILLIN FOR INJECTION USP 2G-BATCH NO | $350.0K | 7 |
| AMPICILLIN (AS SODIUM) POWDER FOR INJECT | $273.4K | 6 |
| AMPICILLIN AND SUBACTAM FOR INJECTION US | $248.9K | 5 |
| AMPICILLIN FOR INJECTION USP 2G 10S (520 | $171.2K | 4 |
| AMPICILLIN & SUIBACTAM FOR INJECTION USP | $150.0K | 3 |
| AMPICILLIN SULBACTUM FOR INJECTION USP 2G 1G 10 S BATCH NO 5200282 PACK SIZE 2793X10S | $100.0K | 2 |
| AMPICILLIN SULBACTUM FOR INJECTION USP 2G 1G 10 S BATCH NO 5200277 PACK SIZE 2728X10S | $100.0K | 2 |
| AMPICILLIN SULBACTUM FOR INJECTION USP 2G 1G 10 S BATCH NO 5200286 PACK SIZE 2601X10S | $100.0K | 2 |
Steriscience Specialties Private Limited exports 160 distinct Ampicillin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is AMPICILLIN AND SULBACTAM FOR INJECTION U with 39 shipments worth $1.5M. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Ampicillin to Key Markets
What Steriscience Specialties Private Limited must comply with to export Ampicillin 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.
Australia — TGA
Approval Process
Registration on Australian Register of Therapeutic Goods (ARTG). Bioequivalence and quality data per TGA guidelines.
Timeline: 10–14 months
GMP & Export Requirements
TGA GMP clearance; PIC/S-aligned inspection. PIC/S certificate from India may expedite.
TGA sponsor licence for Australian importer; GMP clearance per manufacturing site
Note: TGA participates in PIC/S mutual recognition.
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 Steriscience Specialties Private Limited Compare to Nearest Ampicillin Exporters?
Exporters ranked immediately above and below #2 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | STERISCIENCE SPECIALTIES PRIVATE LIMITED ★ | $12.9M | 259 | 3 | $50.0K |
| 3 | SPARSH BIO-TECH PRIVATE LIMITED | $10.4M | 209 | 3 | $50.0K |
| 6 | AUROBINDO PHARMA LTD | $4.7M | 106 | 10 | $44.1K |
Steriscience Specialties Private Limited ranks #2 among 486 Indian Ampicillin exporters. Average shipment value of $50.0K compared to the market average of $108.4K. The closest competitors by value are SPARSH BIO-TECH PRIVATE LIMITED and AUROBINDO PHARMA LTD.
Which Indian Ports Ship Ampicillin Exports?
| Port | Shipments | % Share |
|---|---|---|
| NHAVA SHEVA SEA (INNSA1) | 412 | 9.2% |
| DELHI AIR CARGO ACC (INDEL4) | 317 | 7.1% |
| SAHAR AIR CARGO ACC (INBOM4) | 301 | 6.7% |
| SAHAR AIR | 259 | 5.8% |
| DELHI AIR | 233 | 5.2% |
| BANGALORE ICD | 226 | 5.1% |
| MUNDRA SEA | 205 | 4.6% |
| JNPT/ NHAVA SHEVA SEA | 204 | 4.6% |
Geopolitical & Trade Policy Impact on Steriscience Specialties Private Limited's Ampicillin Exports
The current geopolitical landscape presents both challenges and opportunities for Indian pharmaceutical exporters like Steriscience. The Israel-Iran tensions have led to increased security risks in the Red Sea, prompting major shipping lines to implement 'Emergency Risk Surcharges' ranging from $250 to $500 per Twenty-foot Equivalent Unit (TEU). This escalation in shipping costs directly impacts the profitability of exports to Europe and the US East Coast, necessitating strategic adjustments in logistics and pricing. (sgeexport.com)
Conversely, the US-China trade tensions have opened avenues for Indian pharmaceutical companies to capture market share previously held by Chinese manufacturers. However, the US's push for pharmaceutical manufacturing reshoring and the imposition of tariffs as high as 245% on Active Pharmaceutical Ingredients (APIs) have led to a complex trade environment. Indian firms have responded by investing in US facilities to circumvent these tariffs, with outbound foreign direct investment (OFDI) ranging between $500-700 million during partial FY 2025-26. (odrindia.in)
The India-European Union Free Trade Agreement (FTA), concluded on January 27, 2026, eliminates tariffs on Indian pharmaceuticals, APIs, vaccines, and medical devices entering the EU. This development offers Steriscience a competitive edge in the European market, potentially increasing export volumes and profitability. (en.wikipedia.org)
Steriscience Specialties Private Limited — Regulatory Compliance & Quality Standards
Compliance with international regulatory standards is paramount for Indian pharmaceutical exporters. The US Food and Drug Administration (FDA), World Health Organization (WHO), and European Union Good Manufacturing Practice (EU GMP) certifications are critical for market access. Steriscience's facilities, including the USFDA-approved sterile fill-finish manufacturing facility in Warsaw, Poland, and the integrated carbapenem facility in Vadodara, India, underscore the company's commitment to quality and regulatory adherence. (business-standard.com)
The evolving regulatory landscape, including the EU's Falsified Medicines Directive and the US's stringent import policies, necessitates continuous investment in compliance and quality assurance. Steriscience's proactive approach in aligning with these standards positions it favorably in the global market.
About Steriscience Specialties Private Limited
Steriscience Specialties Private Limited exports 4 products worth $23.8M. Beyond Ampicillin, top products include Piperacillin, Methylprednisolone, Vati. View the complete Steriscience Specialties Private Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Ampicillin — 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: Ampicillin shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Steriscience Specialties Private 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 259 individual customs records matching Steriscience Specialties Private Limited exporting Ampicillin, covering 160 formulations to 3 countries via 11 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 133+ countries, 924+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Ampicillin Export Data from Steriscience Specialties Private Limited
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Steriscience Specialties Private Limited
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4 products · $23.8M total trade · 4 categories
Ampicillin 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 Ampicillin. For current shipment-level data, contact TransData Nexus.