Alkem Laboratories Limited Ezetimibe Export Data — India (DGFT 2022–2026)

Name: Alkem Laboratories Limited Ezetimibe Export Records India — #2 Exporter, 389 Shipments, $19.4M FOB USD (DGFT 2022–2026)
Creator: TransData Nexus
Published: 2026-05-01T00:00:00Z
License: https://transdatanexus.com/terms-and-conditions

Suresh Sormare

Ezetimibe

India Pharmaceutical Trade Intelligence

$514.5M169 Suppliers85 CountriesHS 30049099

ExportsIndia → UNITED STATES44.9%India → GERMANY41.4%

ImportsMALTA → India$3.0M GERMANY → India$37.8K

#1 Supplier: PIRAMAL PHARMA

Alkem Laboratories Limited — Ezetimibe Exporter #2 | $19.4M Trade Value | TransData Nexus | TransData Nexus

Alkem Laboratories Limited — Ezetimibe Exporter Profile

Indian Pharmaceutical Exporter · #2 for Ezetimibe · $19.4M export value · DGFT Verified

Alkem Laboratories Limited is the #2 Indian exporter of Ezetimibe with $19.4M in export value and 389 verified shipments. Alkem Laboratories Limited holds a 3.8% market share in Ezetimibe exports across 5 countries. The company exports 30 pharmaceutical products worth $247.0M across 15 therapeutic categories.

Alkem Laboratories Limited — Ezetimibe Export Profile: Buyers & Destinations

Alkem Laboratories Limited Ezetimibe export treemap — buyers and destination countries | TransData Nexus

Where Does Alkem Laboratories Limited Export Ezetimibe?

Country	Value	Shipments	Share
UNITED STATES	$9.3M	308	80.1%
GERMANY	$942.5K	36	8.1%
AUSTRALIA	$744.1K	46	6.4%
UNITED KINGDOM	$501.1K	11

Who Are the Top Buyers of Ezetimibe from Alkem Laboratories Limited?

Buyer	Country	Value	Orders
ASCEND LABORATORIES,LLC	UNITED STATES	$5.1M	165
ASCEND LABORATORIES LLC	UNITED STATES	$3.0M	100
ASCEND GMBH	GERMANY	$832.8K	32
ASCEND LABORATORIES, LLC	UNITED STATES	$489.7K	14
PHARMACOR PTY LTD	AUSTRALIA	$415.9K	20
ASCEND LABORATORIESLLC	UNITED STATES	$323.5K	11
PHARMACOR PTY LTD.,.	AUSTRALIA	$284.2K	6
ASCEND LABORATORIES (UK) LIMITED .	UNITED KINGDOM	$171.4K	4
ASCEND LABOATORIES,LLC C/O UPS	UNITED STATES	$168.8K	12
ASCEND LABORATORIES (UK)LIMITED	UNITED KINGDOM	$150.0K	3

Alkem Laboratories Limited supplies Ezetimibe to 21 buyers globally. The largest buyer is ASCEND LABORATORIES,LLC (UNITED STATES), followed by ASCEND LABORATORIES LLC (UNITED STATES) and ASCEND GMBH (GERMANY). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.

What Ezetimibe Formulations Does Alkem Laboratories Limited Export?

Product Description / Formulation	Value	Shipments
PHARMACEUTICAL PRODUCTS: EZETIMIBE TABLE	$985.5K	25
EZETIMIBE TABLETS USP 10 MG ( 500S) USA	$455.1K	11
PHARMACEUTICAL PRODUCTS:EZETIMIBE TABLET	$441.4K	11
EZETIMIBE TABLETS 10 MG 10X10 S DE PZN N	$250.0K	5
PHARMACEUTICAL PRODUCTS EZETIMIBE TABLET	$210.6K	5
EZETIMIBE TABLETS USP 10 MG (90S) USA N	$200.0K	4
PHARMACOR EZETIMIBE TAB 10MG 30S HDPE AU	$200.0K	4
EZETIMIBE TABLETS USP 10MG (90'S)USA NDC NO67877049090	$173.5K	4
PHARMACEUTICAL PRODUCTS: EZETIMIBE&SIMVA	$172.4K	13
EZETIMIBE TABLETS USP 10MG (500 S)USA NDC NO67877049005 EACH TABLET CONTAINS: 10 MG EZETIMIBE USP	$157.0K	4

Alkem Laboratories Limited exports 239 distinct Ezetimibe formulations including tablets, capsules, syrups, and combination drugs. The top formulation is PHARMACEUTICAL PRODUCTS: EZETIMIBE TABLE with 25 shipments worth $985.5K.

Regulatory Requirements: Exporting Ezetimibe to Key Markets

What Alkem Laboratories Limited must comply with to export Ezetimibe 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.

Germany — BfArM/EMA

Approval Process

Marketing Authorisation via Decentralized or Mutual Recognition Procedure under EU Directive 2001/83/EC. CTD Module 1–5 dossier required.

Timeline: 12–18 months via Decentralized Procedure

GMP & Export Requirements

EU GMP (EudraLex Vol. 4); GMP certificate from EU competent authority; WHO Prequalification accepted as supporting evidence

Certificate of Pharmaceutical Product (CPP) from CDSCO; Written Confirmation for API export per EU requirements; EU FMD serialization mandatory

Note: Indian manufacturers must hold EU GMP certificate. EU Falsified Medicines Directive (FMD) serialization and tamper-evident packaging mandatory.

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 Alkem Laboratories Limited Compare to Nearest Ezetimibe Exporters?

Exporters ranked immediately above and below #2 by export value

#	Supplier	Export Value	Shipments	Countries	Avg/Shipment
2	ALKEM LABORATORIES LIMITED ★	$19.4M	389	5	$50.0K
3	INTAS PHARMACEUTICALS LIMITED	$16.6M	333	17	$50.0K
1	PIRAMAL PHARMA LIMITED	$13.4M	269	3	$50.0K

Alkem Laboratories Limited ranks #2 among 169 Indian Ezetimibe exporters. Average shipment value of $50.0K compared to the market average of $628.6K. The closest competitors by value are INTAS PHARMACEUTICALS LIMITED and PIRAMAL PHARMA LIMITED.

Which Indian Ports Ship Ezetimibe Exports?

Port	Shipments	% Share
SAHAR AIR	814	16.2%
SAHAR AIR CARGO ACC (INBOM4)	663	13.2%
DELHI AIR CARGO ACC (INDEL4)	515	10.2%
DELHI AIR	369	7.3%
NHAVA SHEVA SEA (INNSA1)	235	4.7%
Bombay Air	164	3.3%
BANGALORE AIR	152	3.0%
MUNDRA SEA	150	3.0%

Geopolitical & Trade Policy Impact on Alkem Laboratories Limited's Ezetimibe Exports

The current geopolitical climate presents both challenges and opportunities for Indian pharmaceutical exporters like Alkem Laboratories. Escalating tensions in the Red Sea region, particularly due to Houthi attacks, have disrupted traditional shipping routes, leading to increased freight costs and extended delivery timelines. Major carriers have rerouted vessels around the Cape of Good Hope, adding 10–20 days to transit times and raising freight rates by 40–50% on key India–Europe routes (livemint.com). This logistical upheaval necessitates strategic adjustments in supply chain management to mitigate delays and cost escalations.

Conversely, the ongoing US-China trade tensions have prompted the United States to diversify its pharmaceutical supply sources, potentially benefiting Indian exporters. Alkem's established presence in the US market positions it to capitalize on this shift, provided it maintains stringent compliance with US regulatory standards. Additionally, the recent India–European Union Free Trade Agreement, signed in January 2026, aims to eliminate tariffs on pharmaceuticals, enhancing the competitiveness of Indian exporters in the EU market (en.wikipedia.org). However, compliance with the EU's Falsified Medicines Directive remains imperative to ensure market access.

Alkem Laboratories Limited — Regulatory Compliance & Quality Standards

Regulatory compliance is paramount for sustaining export operations in stringent markets like the US and EU. Alkem's subsidiary, Enzene Biosciences, recently underwent a USFDA inspection at its Chakan facility, resulting in six procedural observations but no data integrity issues (m.economictimes.com). This outcome underscores the company's commitment to quality assurance and regulatory adherence. Continuous investment in compliance infrastructure and proactive engagement with regulatory bodies are essential for Alkem to navigate the evolving global regulatory landscape effectively.

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.

Analysis Methodology

1.Product Matching: Ezetimibe shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
2.Supplier Identification: Alkem Laboratories 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 415 individual customs records matching Alkem Laboratories Limited exporting Ezetimibe, covering 239 formulations to 5 countries via 21 buyers.

Government-Sourced Data

Official DGFT customs records

Transparent Methodology

Calculations fully disclosed above

Global Coverage

Exports to 85+ countries, 466+ buyers

Expert-Reviewed

Analyzed by pharmaceutical trade specialists

Ezetimibe

Ezetimibe

Alkem Laboratories Limited — Ezetimibe Exporter Profile

Alkem Laboratories Limited — Ezetimibe Export Profile: Buyers & Destinations

Where Does Alkem Laboratories Limited Export Ezetimibe?

Who Are the Top Buyers of Ezetimibe from Alkem Laboratories Limited?

What Is India's Total Ezetimibe Export Value and How Much Does Alkem Laboratories Limited Contribute?

What Is the Average Shipment Value for Alkem Laboratories Limited's Ezetimibe Exports?

How Does Alkem Laboratories Limited Compare to Other Indian Ezetimibe Exporters?

What Ezetimibe Formulations Does Alkem Laboratories Limited Export?

Regulatory Requirements: Exporting Ezetimibe to Key Markets

United States — FDA

Germany — BfArM/EMA

Australia — TGA

How Does Alkem Laboratories Limited Compare to Nearest Ezetimibe Exporters?

Which Indian Ports Ship Ezetimibe Exports?

What Other Lipid & Metabolism Products Does Alkem Laboratories Limited Export?

Ezetimibe — Export Intelligence Video

Geopolitical & Trade Policy Impact on Alkem Laboratories Limited's Ezetimibe Exports

Alkem Laboratories Limited — Regulatory Compliance & Quality Standards

About Alkem Laboratories Limited

Market Intelligence

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

Analysis Methodology

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