Amneal Pharmaceuticals, Llc Pharmaceutical Import Profile — United States (DGFT 2022–2026)

Name: Amneal Pharmaceuticals, Llc Pharmaceutical Import Records from India — 9 Products, $16.7M FOB USD (DGFT 2022–2026)
Creator: TransData Nexus

Suresh Sormare

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Amneal Pharmaceuticals, Llc — Pharmaceutical Importer Profile (2026) | 9 Products, $16.7M Trade | TransData Nexus

Who Are the Verified Indian Suppliers to Amneal Pharmaceuticals, Llc?

Customs-verified supplier relationships from Indian DGFT records

Supplier	Value	Shipments	Share
Amneal Pharmaceuticals Private Limited	$83.0M	2,337	99.7%
Amneal Injectables Private Limited	$178.8K	5	0.2%
Strides Pharma Science Limited	$100.0K	2	0.1%
Puniska Healthcare Private Limited	$805	1	0.0%
Steriscience Specialties Private Limited	$419	1	0.0%

Amneal Pharmaceuticals, Llc sources from 5 verified Indian suppliers across 511 distinct formulations. The sourcing is highly concentrated — Amneal Pharmaceuticals Private Limited accounts for 99.7% of total imports, indicating a strategic single-source relationship.

What Formulations Does Amneal Pharmaceuticals, Llc Import?

Formulation	Value	Ships
Gabapentin capsules, USP 300MG ndc	$2.7M	54
Colestipol hydrochloride tablets, USP	$2.6M	52
Potassium chloride extended-release	$2.2M	60
Oseltamivir phosphate capsules, 75 MG	$1.6M	33
Spironolactone tablets,usp25mg ndc	$1.5M	31
Divalproex sodium er TAB 500MG ndc	$1.4M	34
Spironolactone tablets,usp50mg ndc	$1.3M	27

What Products Does Amneal Pharmaceuticals, Llc Import?

Top Products by Import Value

1Magnesium$5.4M 2Tramadol$3.5M 3Calcium$3.1M 4Iron$1.3M 5Spironolactone$1.3M 6Phenylephrine$1.2M

Import Portfolio — Top 9 by Import Value

#	Product	Category	Value	Ships	Share	Rk
1	Magnesium	Vitamins & Supplements	$5.4M	108	1.5%	10
2	Tramadol	Analgesics & Antipyretics	$3.5M	69	0.6%

Key Metrics

Total Import Value$16.7M

Products9

Shipments352

Categories6

CountryUnited States

#1 Rankings0

Indian Suppliers5

Formulations511

Top Categories

Vitamins & Supplements58.7%

Analgesics & Antipyretics23.9%

Last updated: March 28, 2026

Amneal Pharmaceuticals, Llc — Corporate Profile & Information

Company type, headquarters, distribution network, and industry role

1Company Overview

Amneal Pharmaceuticals LLC is a U.S.-based pharmaceutical company specializing in the development, manufacturing, and distribution of generic and specialty drug products. Founded in 2002 by brothers Chirag and Chintu Patel, the company is headquartered in Bridgewater, New Jersey. Amneal has grown to become one of the largest manufacturers of generic drugs in the United States, offering a diverse portfolio that includes over 290 products across various therapeutic areas.

In 2018, Amneal Pharmaceuticals LLC merged with Impax Laboratories, Inc., forming Amneal Pharmaceuticals, Inc. This strategic move expanded the company's capabilities and market presence. The merger was valued at $1.45 billion and required the divestiture of several marketed products and development projects as a condition of approval.

Amneal's product offerings span complex generics, injectables, biosimilars, and specialty medicines, with a focus on central nervous system and endocrine disorders. The company operates manufacturing facilities in New Jersey, New York, India, and Ireland, and has distribution and commercial operations in Glasgow, Kentucky.

2Distribution Network

Amneal Pharmaceuticals LLC has established a robust distribution network to ensure the efficient delivery of its products across the United States and internationally. The company operates manufacturing plants in Branchburg and Piscataway, New Jersey; Brookhaven and Hauppauge, New York; India; and Ireland. Additionally, Amneal has distribution and commercial operations in Glasgow, Kentucky, facilitating nationwide coverage.

Supplier Relationship Intelligence — Amneal Pharmaceuticals, Llc

Sourcing concentration, supply chain resilience, and strategic implications

1Sourcing Concentration Analysis

Amneal Pharmaceuticals LLC's sourcing strategy exhibits a high degree of concentration, with a significant portion of its imported pharmaceutical formulations originating from a single supplier, Amneal Pharmaceuticals Private Limited. This supplier accounted for $83.0 million in imports, representing 99.7% of the total value. The remaining imports were sourced from Amneal Injectables Private Limited ($179K, 0.2%), Strides Pharma Science Limited ($100K, 0.1%), Puniska Healthcare Private Limited ($805, 0.0%), and Steriscience Specialties Private Limited ($419, 0.0%).

This sourcing pattern indicates a strategic choice to maintain a streamlined supply chain, potentially benefiting from economies of scale and simplified logistics. However, such concentration also introduces risks related to supplier dependency, including potential disruptions due to regulatory changes, supply chain interruptions, or quality control issues.

The stability of the relationship with Amneal Pharmaceuticals Private Limited is crucial for Amneal Pharmaceuticals LLC's operations. The high volume of imports from this supplier suggests a long-standing and reliable partnership. Nonetheless, the company should continuously assess and manage risks associated with this concentration to ensure a resilient and adaptable supply chain.

2Supply Chain Resilience

Amneal Pharmaceuticals LLC's supply chain resilience is closely tied to its sourcing strategy, which is heavily concentrated on a single supplier, Amneal Pharmaceuticals Private Limited. This concentration can lead to vulnerabilities, particularly if the supplier faces operational challenges, regulatory issues, or geopolitical disruptions.

To mitigate these risks, Amneal Pharmaceuticals LLC should consider diversifying its supplier base and establishing relationships with additional manufacturers. This approach would enhance supply chain flexibility and reduce dependency on a single source. Additionally, evaluating the regulatory compliance and quality assurance practices of all suppliers is essential to maintain product integrity and meet U.S. Food and Drug Administration (FDA) standards.

By proactively addressing these aspects, Amneal Pharmaceuticals LLC can strengthen its supply chain resilience, ensuring a consistent and reliable supply of pharmaceutical products to the U.S. market.

3Strategic Implications

The current sourcing pattern of Amneal Pharmaceuticals LLC, characterized by a high dependency on a single supplier, has significant strategic implications. While this approach may offer operational efficiencies and cost benefits, it also exposes the company to potential risks associated with supplier disruptions.

For Indian exporters seeking to become alternative suppliers to Amneal Pharmaceuticals LLC, this presents an opportunity to diversify the company's supply chain. By offering high-quality pharmaceutical formulations that meet FDA standards, Indian exporters can position themselves as viable partners. Establishing strong relationships and demonstrating reliability in meeting regulatory requirements will be key to gaining Amneal's trust and expanding their role in the company's supply chain.

TransData Nexus Research · Verified DGFT customs dataMar 2026

Importing Pharmaceuticals into United States — Regulatory Framework

Regulatory authority, GMP requirements, import licensing for United States

1Regulatory Authority & Framework

In the United States, the Food and Drug Administration (FDA) serves as the primary regulatory authority overseeing the importation of pharmaceutical products. The FDA ensures that all drugs entering the U.S. market meet standards for quality, safety, and effectiveness.

Key legislation governing pharmaceutical imports includes the Federal Food, Drug, and Cosmetic Act (FDCA), which outlines requirements for drug approval, labeling, and manufacturing practices. The Drug Enforcement Administration (DEA) also regulates controlled substances, imposing additional requirements for their importation.

For Indian pharmaceutical companies exporting to the U.S., obtaining FDA approval for each drug product is mandatory. This process involves submitting an Abbreviated New Drug Application (ANDA) for generics or a New Drug Application (NDA) for new drugs, demonstrating that the product is bioequivalent to its brand-name counterpart and meets all FDA standards.

2Import Licensing & GMP

Import licensing requirements for pharmaceutical products entering the United States are stringent. All foreign drug establishments whose products are imported must register with the FDA and list all their drug products in commercial distribution in the U.S.

Good Manufacturing Practice (GMP) certification is essential for ensuring product quality and safety. The FDA recognizes GMP certifications from the European Union (EU GMP), World Health Organization (WHO GMP), and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Indian exporters seeking to supply Amneal Pharmaceuticals LLC must ensure their manufacturing facilities comply with these recognized GMP standards.

Additionally, obtaining wholesale distribution authorization is necessary for companies involved in the distribution of pharmaceutical products within the U.S. This authorization ensures that distributors adhere to regulatory requirements and maintain the integrity of the pharmaceutical supply chain.

3Quality & Labeling

Imported pharmaceutical products must undergo batch testing to verify their quality, potency, and purity. This testing ensures that products meet FDA standards and are safe for consumer use.

Stability requirements are also critical, as they determine the shelf life and efficacy of pharmaceutical products. Manufacturers must conduct stability studies to establish expiration dates and storage conditions.

Labeling requirements include providing accurate and comprehensive information in English, including dosage instructions, active ingredients, and potential side effects. Serialization mandates may also apply, requiring unique identifiers on packaging to enhance traceability and prevent counterfeit products.

4Recent Regulatory Changes

Between 2024 and 2026, several policy changes have impacted the importation of pharmaceutical products from India to the United States. The FDA has implemented stricter enforcement of GMP compliance, increasing inspections of foreign manufacturing facilities. Additionally, there has been a heightened focus on ensuring the integrity of the pharmaceutical supply chain, leading to more rigorous labeling and serialization requirements.

These regulatory changes aim to enhance patient safety and product quality. Indian pharmaceutical exporters must stay informed about these developments to maintain compliance and continue exporting to the U.S. market.

TransData Nexus Research · United States regulatory databasesMar 2026

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.Buyer Matching: Amneal Pharmaceuticals, Llc identified across shipments using consignee name normalization, aggregating 2 name variants.
2.Statistical Normalization: Shipment values are statistically normalized to ensure accurate market share representation.
3.Market Share: Calculated per product as Amneal Pharmaceuticals, Llc's capped value divided by total Indian exports for that product.
4.Shipment Count: Based on 352 individual customs records matching Amneal Pharmaceuticals, Llc.
5.Supplier Verification: Amneal Pharmaceuticals, Llc sources from 5 verified Indian suppliers across 511 formulations, confirmed from customs records.

Government-Sourced Data

Official DGFT customs records

Transparent Methodology

Calculations fully disclosed above

9 Products Tracked

6 therapeutic categories

Expert-Reviewed

By pharmaceutical trade specialists

Amneal Pharmaceuticals, Llc

Amneal Pharmaceuticals, Llc — Import Portfolio & Supplier Network

Who Are the Verified Indian Suppliers to Amneal Pharmaceuticals, Llc?

What Formulations Does Amneal Pharmaceuticals, Llc Import?

What Products Does Amneal Pharmaceuticals, Llc Import?

Top Products by Import Value

Import Portfolio — Top 9 by Import Value

Key Metrics

Top Categories

Amneal Pharmaceuticals, Llc — Corporate Profile & Information

1Company Overview

2Distribution Network

Amneal Pharmaceuticals, Llc Therapeutic Categories — 6 Specializations

Indian Suppliers

Related Trade Data

Need Detailed Data?

3Industry Role

Supplier Relationship Intelligence — Amneal Pharmaceuticals, Llc

1Sourcing Concentration Analysis

2Supply Chain Resilience

3Strategic Implications

Importing Pharmaceuticals into United States — Regulatory Framework

1Regulatory Authority & Framework

2Import Licensing & GMP

3Quality & Labeling

4Recent Regulatory Changes

Amneal Pharmaceuticals, Llc — Procurement Pattern Analysis

1Product Strategy

Frequently Asked Questions — Amneal Pharmaceuticals, Llc

What products does Amneal Pharmaceuticals, Llc import from India?

Who supplies pharmaceuticals to Amneal Pharmaceuticals, Llc from India?

What is Amneal Pharmaceuticals, Llc's total pharmaceutical import value?

What therapeutic categories does Amneal Pharmaceuticals, Llc focus on?

Get Full Amneal Pharmaceuticals, Llc Import Intelligence

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

Analysis Methodology

Data Source & Methodology