Saxagliptin Export Market Intelligence: India's 30 Suppliers Shipping to 16 Countries — TransData Nexus 2026

Q: Who are the top saxagliptin exporters from India?

The top saxagliptin exporters from India are: 1. MYLAN LABORATORIES LIMITED — $3.6M (90.0% market share); 2. SAM LIFESTYLE — $259.3K (6.5% market share); 3. LOTUS INTERNATIONAL — $18.9K (0.5% market share); 4. SHREE SSD PHARMA PRIVATE LIMITED — $13.9K (0.4% market share); 5. HEXA HEALTHCARE PVT LTD — $10.8K (0.3% market share). Together they account for 97.6% of India's total saxagliptin export value.

Q: What is the total export value of saxagliptin from India?

The total export value of saxagliptin from India is $4.0M USD, recorded across 258 shipment transactions from 30 active exporters to 16 destination countries. The average shipment value is $15.4K.

Q: Which countries import saxagliptin from India?

India exports saxagliptin to 16 countries worldwide. The top importing countries are: UNITED STATES (91.1% share, $3.6M), IRAQ (7.2% share, $288.3K), SINGAPORE (0.8% share, $33.1K), MAURITIUS (0.6% share, $24.5K), KENYA (0.1% share, $2.1K). These five markets account for 99.9% of total export value.

Q: What is the HS code for saxagliptin exports from India?

The primary HS code for saxagliptin exports from India is 30049099. This 8-digit classification falls under Chapter 30 (pharmaceutical products) of the Harmonized System and is used by Indian Customs (DGFT) for tracking and reporting pharmaceutical trade flows.

Q: What is the average price of saxagliptin exports from India?

The average unit price for saxagliptin exports from India is $14.95 USD per unit, with prices ranging from $0.21 to $1062.27 depending on formulation, packaging, and order volume. The total market is valued at $4.0M across 258 shipments.

Q: Which ports handle saxagliptin exports from India?

The primary ports for saxagliptin exports from India are SAHAR AIR (39.5% of shipments), SAHAR AIR CARGO ACC (INBOM4) (10.1% of shipments), Bombay Air (10.1% of shipments), DELHI AIR CARGO ACC (INDEL4) (8.9% of shipments), DELHI AIR (7.8% of shipments). These ports have dedicated pharmaceutical cargo infrastructure ensuring cold-chain and regulatory compliance during transit.

Q: Why is India a leading exporter of saxagliptin?

India is one of the world's leading exporters of saxagliptin due to its large base of 30 WHO-GMP and US FDA approved manufacturers, significantly lower production costs compared to Western markets, well-established API (Active Pharmaceutical Ingredient) supply chains, and strong government support for pharmaceutical exports through the Pharmaceuticals Export Promotion Council (Pharmexcil). India exports saxagliptin to 16 countries, demonstrating 8% global market coverage.

Q: What certifications do Indian saxagliptin exporters need?

Indian saxagliptin exporters typically require WHO-GMP (Good Manufacturing Practice) certification for most regulated markets, US FDA approval for exports to the United States, EU GMP certification for European markets, and country-specific regulatory approvals for markets in Africa, Asia, and Latin America. Additional certifications may include ISO 9001, Schedule M compliance under Indian drug laws, and Free Sale Certificates issued by the Central Drugs Standard Control Organization (CDSCO).

Q: How many buyers import saxagliptin from India?

There are 41 registered buyers importing saxagliptin from India, spread across 16 countries. The repeat buyer rate is 56.1%, indicating strong long-term trade relationships and consistent product quality.

Q: What is the market share of the top saxagliptin supplier from India?

MYLAN LABORATORIES LIMITED is the leading saxagliptin exporter from India with a market share of 90.0% and total export value of $3.6M across 40 shipments. The top 5 suppliers together control 97.6% of total export value.

Suresh Sormare

Saxagliptin

India Pharmaceutical Trade Intelligence

$4.0M30 Suppliers16 CountriesHS 30049099

ExportsIndia → UNITED STATES91.1%India → IRAQ7.2%

ImportsUNITED STATES → India$428.3M SWEDEN → India$845.6K

#1 Supplier: MYLAN LABORATORIES #1 Buyer: MYLAN PHARMACEUTICALS

Saxagliptin Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Saxagliptin to the World

Between 2022 and 2026, India exported $4.0M worth of saxagliptin across 258 verified shipments to 16 countries — covering 8% of world markets in the Advanced Diabetes Medications segment. The largest destination is UNITED STATES (91.1%). MYLAN LABORATORIES LIMITED leads with a 90.0% share. All figures are drawn from Indian Customs (DGFT) shipping bill records spanning four years of trade activity.

Source: Indian Customs (DGFT)·Published March 2026·Updated March 2026·

Saxagliptin export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Saxagliptin export data snapshot — $4.0M · 30 exporters · 16 countriesTransData Nexus · Indian Customs Data

Top Saxagliptin Exporters from India

30 active exporters · Ranked by export value

View all 30 →

Top Saxagliptin Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	MYLAN LABORATORIES LIMITED	$3.6M	40	1	90.0%
2	SAM LIFESTYLE

Top Countries Importing Saxagliptin from India

16 destination markets · Ranked by import value

All 16 countries →

Top Countries Importing Saxagliptin from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$3.6M	91.1%
2	IRAQ	$288.3K	7.2%
3	SINGAPORE	$33.1K	0.8%
4	MAURITIUS	$24.5K	0.6%
5	KENYA	$2.1K	0.1%
6	SOMALIA	$1.6K	0.0%
7	BELGIUM	$1.5K	0.0%
8	SWITZERLAND	$728	0.0%
9	YEMEN	$340	0.0%
10	EGYPT	$331	0.0%

UNITED STATES is India's largest saxagliptin export destination, absorbing 91.1% of total exports worth $3.6M. The top 5 importing countries — UNITED STATES, IRAQ, SINGAPORE, MAURITIUS, KENYA — together account for 99.9% of India's total saxagliptin export value. The remaining 11 destination countries collectively receive the other 0.1%, indicating a focused distribution strategy targeting key markets.

Who Supplies Saxagliptin to India?

10 origin countries · Total import value: $429.2M

India imports saxagliptin from 10 countries with a combined import value of $429.2M. The largest supplier is UNITED STATES ($428.3M, 29 shipments), followed by SWEDEN and CHINA. All values are from Indian Customs (DGFT) import records.

Countries Supplying Saxagliptin to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$428.3M	29	99.8%
2	SWEDEN	$845.6K	7	0.2%
3	CHINA	$70.4K	4	0.0%
4	GERMANY	$10.5K	6	0.0%
5	PORTUGAL	$1.8K	1	0.0%
6	NETHERLANDS	$710	1	0.0%
7	IRELAND	$576	1	0.0%
8	MALTA	$379	21	0.0%
9	CANADA	$379	1	0.0%
10	ROMANIA	$281	1	0.0%

UNITED STATES is the largest supplier of saxagliptin to India, accounting for 99.8% of total import value. The top 5 origin countries — UNITED STATES, SWEDEN, CHINA, GERMANY, PORTUGAL — together supply 100.0% of India's saxagliptin imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Saxagliptin

Product-specific regulatory status across FDA, EMA, WHO, and CDSCO · As of March 2026

1FDA & US Market Regulatory Status

In the United States, saxagliptin is marketed under the brand name Onglyza. The FDA approved the first Abbreviated New Drug Application (ANDA) for saxagliptin tablets (2.5 mg and 5 mg) submitted by Amneal Pharmaceuticals LLC on November 30, 2025. This approval signifies the availability of generic versions, potentially increasing market competition and affecting pricing dynamics. Given that 91.1% of India's saxagliptin exports are directed to the U.S., the entry of generics could influence export volumes and pricing strategies for Indian manufacturers.

As of March 2026, there are no active FDA import alerts or significant regulatory actions concerning saxagliptin. The primary regulatory pathway for saxagliptin involves the submission of an ANDA, demonstrating bioequivalence to the reference listed drug, Onglyza. With 30 active Indian exporters and a repeat buyer rate of 56.1%, maintaining compliance with FDA regulations is crucial to sustain and expand market presence in the U.S.

2EU & UK Regulatory Framework

In the European Union, saxagliptin received marketing authorization under the brand name Onglyza on October 1, 2009. The European Medicines Agency (EMA) has not reported any significant regulatory actions affecting saxagliptin since its approval. The combination product Qtern, containing saxagliptin and dapagliflozin, was authorized on July 15, 2016. However, AstraZeneca withdrew an application to extend Qtern's use on April 3, 2018, indicating strategic adjustments in the product's market positioning.

In the United Kingdom, post-Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the regulation of medicines. Saxagliptin continues to be available, with regulatory requirements aligning closely with those of the EMA. Compliance with EU Good Manufacturing Practice (GMP) standards is mandatory for manufacturers exporting to these regions, ensuring product quality and safety.

3WHO Essential Medicines & Global Standards

As of March 2026, saxagliptin is not listed on the World Health Organization's (WHO) Model List of Essential Medicines. Consequently, it has not undergone WHO Prequalification, a program that assesses the quality, safety, and efficacy of medicinal products. However, saxagliptin formulations are expected to comply with international pharmacopoeia standards, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), to ensure consistent quality across markets.

4India Regulatory Classification

In India, saxagliptin is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for saxagliptin as of March 2026, allowing market-driven pricing. For exports, manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations and facilitating international trade.

5Patent & Exclusivity Status

The primary patent for saxagliptin expired in July 2023, opening the market to generic competition. This development has led to increased market entry by generic manufacturers, both domestically and internationally, influencing pricing and market dynamics.

6Recent Industry Developments

In November 2025, the FDA approved the first generic version of saxagliptin tablets, marking a significant milestone in increasing accessibility and affordability of the medication. This approval is expected to impact export strategies for Indian manufacturers targeting the U.S. market.

In January 2026, the EMA updated the product information for Onglyza, incorporating new safety data related to cardiovascular risks. Manufacturers exporting to the EU must ensure that their product labeling reflects these updates to maintain compliance and market authorization.

In March 2026, the NPPA announced a review of pricing policies for DPP-4 inhibitors, including saxagliptin, to assess the need for potential price controls. While no immediate changes were implemented, manufacturers should monitor policy developments that could affect domestic pricing and export profitability.

These developments underscore the importance of staying informed about regulatory changes and market dynamics to effectively navigate the global pharmaceutical landscape for saxagliptin.

TransData Nexus Research · FDA Orange Book, EMA, WHO Model List, CDSCO/NPPAUpdated Mar 2026

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Global Price Benchmark — Saxagliptin

Retail & reference prices across 9 markets vs. India FOB export price of $14.95/unit

Global Price Benchmark for Saxagliptin across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$7.58	USD	According to the FDA's Orange Book, Saxagliptin is approved for use in the United States.
United Kingdom	$0.79	GBP	As per the British National Formulary (BNF), Saxagliptin is listed for use in the UK.
Germany	Data not available	EUR	Saxagliptin is approved by the European Medicines Agency (EMA) for use in Germany.
Australia	Data not available	AUD

Supply Chain Risk Assessment — Saxagliptin

API sourcing, concentration risk, storage requirements, and current alerts

HIGH RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, including the production of Saxagliptin, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 70-80% of India's API and KSM requirements are sourced from China, underscoring a significant dependency. This reliance exposes the supply chain to vulnerabilities, particularly when Chinese manufacturers face operational disruptions. For instance, in 2018, environmental regulations led to the shutdown of over 140 API manufacturers in the Beijing-Tianjin-Hebei region due to effluent violations, causing global supply chain disruptions.

The Indian government has recognized this dependency as a strategic risk and, in 2020, introduced the Production Linked Incentive (PLI) scheme with an outlay of ₹6,940 crore to bolster domestic API and KSM production. Despite these efforts, the sector continues to grapple with challenges such as high manufacturing costs, stringent environmental regulations, and competition from countries like Vietnam investing in API production.

2Supplier Concentration & Single-Source Risk

TransData Nexus's proprietary trade data from 2022 to 2026 reveals a high supplier concentration in Saxagliptin exports from India. The top five exporters account for 97.6% of the total export value, with MYLAN LABORATORIES LIMITED alone contributing 90.0%. Such concentration poses a significant single-source risk; any operational issues at these key suppliers could disrupt the entire supply chain.

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Frequently Asked Questions — Saxagliptin Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top saxagliptin exporters from India?

The leading saxagliptin exporters from India are MYLAN LABORATORIES LIMITED, SAM LIFESTYLE, LOTUS INTERNATIONAL, and 8 others. MYLAN LABORATORIES LIMITED leads with 90.0% market share ($3.6M). The top 5 suppliers together control 97.6% of total export value.

What is the total export value of saxagliptin from India?

The total export value of saxagliptin from India is $4.0M, recorded across 258 shipments from 30 active exporters to 16 countries. The average shipment value is $15.4K.

Which countries import saxagliptin from India?

India exports saxagliptin to 16 countries. The top importing countries are UNITED STATES (91.1%), IRAQ (7.2%), SINGAPORE (0.8%), MAURITIUS (0.6%), KENYA (0.1%), which together account for 99.9% of total export value.

What is the HS code for saxagliptin exports from India?

The primary HS code for saxagliptin exports from India is 30049099. This 8-digit classification falls under Chapter 30 (pharmaceutical products) of the Harmonized System and is used by Indian Customs (DGFT) to track and report pharmaceutical export flows.

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Verified Author

Pharmaceutical 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/sureshsormare

Primary 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.

Saxagliptin

Saxagliptin

Top Saxagliptin Exporters from India

Top Countries Importing Saxagliptin from India

Who Supplies Saxagliptin to India?

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Regulatory Landscape — Saxagliptin

1FDA & US Market Regulatory Status

2EU & UK Regulatory Framework

3WHO Essential Medicines & Global Standards

4India Regulatory Classification

5Patent & Exclusivity Status

6Recent Industry Developments

Global Price Benchmark — Saxagliptin

Supply Chain Risk Assessment — Saxagliptin

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Saxagliptin Trade Intelligence

Frequently Asked Questions — Saxagliptin Exports from India

Who are the top saxagliptin exporters from India?

What is the total export value of saxagliptin from India?

Which countries import saxagliptin from India?

What is the HS code for saxagliptin exports from India?

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

India Cost Advantage

3Geopolitical & Shipping Disruptions

4Risk Mitigation Recommendations

What is the average price of saxagliptin exports from India?

Which ports handle saxagliptin exports from India?

Why is India a leading exporter of saxagliptin?

What certifications do Indian saxagliptin exporters need?

How many buyers import saxagliptin from India?

What is the market share of the top saxagliptin exporter from India?

Analysis Methodology