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

Name: Alkem Laboratories Limited Ras Export Records India — #6 Exporter, 138 Shipments, $6.9M FOB USD (DGFT 2022–2026)
Creator: TransData Nexus
Published: 2026-05-01T00:00:00Z
License: https://transdatanexus.com/terms-and-conditions

Suresh Sormare

Ras

India Pharmaceutical Trade Intelligence

$307.2M1,156 Suppliers176 CountriesHS 30049099

ExportsIndia → UNITED STATES29.3%India → SINGAPORE13.2%

#1 Supplier: CIPLA LIMITED

Alkem Laboratories Limited — Ras Exporter #6 | $6.9M Trade Value | TransData Nexus | TransData Nexus

Alkem Laboratories Limited — Ras Exporter Profile

Indian Pharmaceutical Exporter · #6 for Ras · $6.9M export value · DGFT Verified

Alkem Laboratories Limited is the #6 Indian exporter of Ras with $6.9M in export value and 138 verified shipments. Alkem Laboratories Limited holds a 2.2% market share in Ras exports across 6 countries. The company exports 30 pharmaceutical products worth $247.0M across 15 therapeutic categories.

Alkem Laboratories Limited — Ras Export Profile: Buyers & Destinations

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

Where Does Alkem Laboratories Limited Export Ras?

Country	Value	Shipments	Share
UNITED STATES	$7.5M	229	93.4%
AUSTRALIA	$324.5K	22	4.1%
GERMANY	$53.1K	6	0.7%
UNITED KINGDOM	$50.0K	1	0.6%

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

Buyer	Country	Value	Orders
ASCEND LABORATORIES,LLC	UNITED STATES	$3.4M	92
ASCEND LABORATORIES LLC	UNITED STATES	$2.8M	90
ASCEND LABOATORIES,LLC C/O UPS	UNITED STATES	$419.4K	25
NORTHSTAR DISTRIBUTION CENTER 8912	UNITED STATES	$289.6K	10
ASCEND LABORATORIESLLC	UNITED STATES	$220.9K	5
PHARMACOR PTY LTD	AUSTRALIA	$207.6K	15
ASCEND LABORATORIES, LLC.,	UNITED STATES	$150.0K	3
PHARMACOR PTY LIMITED	AUSTRALIA	$105.5K	3
NORTHSTAR DISTRIBUTION CENTER	UNITED STATES	$99.7K	2
ASCEND LABOATORIES LLC	UNITED STATES	$50.0K	1

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

What Ras Formulations Does Alkem Laboratories Limited Export?

Product Description / Formulation	Value	Shipments
PHARMACEUTICAL PRODUCTS:LURASIDONE HCL T	$209.8K	6
DEFERASIROX ORAL GRANULES 90MG EACH SACHET CONT. 155MG GRANUEL EQUIVALENT TO DEFERASIROX 90MG [500 PACK x 1x30x155MG]	$200.0K	4
Pharmaceutical Products - DEFERASIROX ORAL GRANULES360MG 30SACHETS	$150.0K	3
Pharmaceutical Products: DEFERASIROX ORA	$148.4K	3
PHARMACEUTICAL PRODUCTS LURASIDONE HCL T	$145.1K	5
PHARMACEUTICAL PRODUCTS: LURASIDONE HCLTABS 60MG(30'S) NDC NO67877064030	$130.1K	3
LURASIDONE HCL TABS 120MG(30S) NDC No67	$125.2K	3
LURASIDONE HCL TABS 60 MG (30S) NDC NO.	$123.5K	3
LURASIDONE HCL TABS 80MG(30S) NDC No678	$122.6K	4
PHARMACEUTICAL PRODUCTS: LURASIDONE HCL	$115.5K	4

Alkem Laboratories Limited exports 180 distinct Ras formulations including tablets, capsules, syrups, and combination drugs. The top formulation is PHARMACEUTICAL PRODUCTS:LURASIDONE HCL T with 6 shipments worth $209.8K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.

Regulatory Requirements: Exporting Ras to Key Markets

What Alkem Laboratories Limited must comply with to export Ras 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.

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.

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.

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 Ras Exporters?

Exporters ranked immediately above and below #6 by export value

#	Supplier	Export Value	Shipments	Countries	Avg/Shipment
3	MYLAN LABORATORIES LIMITED	$20.1M	402	16	$50.0K
1	CIPLA LIMITED	$8.3M	166	21	$50.0K
6	ALKEM LABORATORIES LIMITED ★	$6.9M	138	6	$50.0K
7	DR.REDDY'S LABORATORIES LTD	$6.0M	119	12	$50.0K
8	USV PRIVATE LIMITED	$4.9M	98	9	$50.0K

Alkem Laboratories Limited ranks #6 among 1156 Indian Ras exporters. Average shipment value of $50.0K compared to the market average of $106.8K. The closest competitors by value are MYLAN LABORATORIES LIMITED and CIPLA LIMITED.

Which Indian Ports Ship Ras Exports?

Port	Shipments	% Share
SAHAR AIR CARGO ACC (INBOM4)	1,417	9.4%
DELHI AIR CARGO ACC (INDEL4)	1,335	8.9%
NHAVA SHEVA SEA (INNSA1)	947	6.3%
SAHAR AIR	935	6.2%
DELHI AIR	709	4.7%
Bombay Air	648	4.3%
AHEMDABAD AIR ACC (INAMD4)	528	3.5%
TUTICORIN SEA (INTUT1)	406	2.7%

Geopolitical & Trade Policy Impact on Alkem Laboratories Limited's Ras 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: Ras 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 276 individual customs records matching Alkem Laboratories Limited exporting Ras, covering 180 formulations to 9 countries via 21 buyers.

Government-Sourced Data

Official DGFT customs records

Transparent Methodology

Calculations fully disclosed above

Global Coverage

Exports to 176+ countries, 2,323+ buyers

Expert-Reviewed

Analyzed by pharmaceutical trade specialists

Ras

Ras

Alkem Laboratories Limited — Ras Exporter Profile

Alkem Laboratories Limited — Ras Export Profile: Buyers & Destinations

Where Does Alkem Laboratories Limited Export Ras?

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

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

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

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

What Ras Formulations Does Alkem Laboratories Limited Export?

Regulatory Requirements: Exporting Ras to Key Markets

United States — FDA

Australia — TGA

Germany — BfArM/EMA

How Does Alkem Laboratories Limited Compare to Nearest Ras Exporters?

Which Indian Ports Ship Ras Exports?

Geopolitical & Trade Policy Impact on Alkem Laboratories Limited's Ras 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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