HYDROCODONE BITARTRATE AND IBUPROFEN: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms Ny	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076642	ANDA	Amneal Pharmaceuticals of New York LLC	53746-116-01	100 TABLET in 1 BOTTLE (53746-116-01)	2010-02-18
Amneal Pharms Ny	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076642	ANDA	Amneal Pharmaceuticals of New York LLC	53746-117-01	100 TABLET in 1 BOTTLE (53746-117-01)	2010-02-18
Amneal Pharms Ny	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076642	ANDA	Amneal Pharmaceuticals of New York LLC	53746-145-01	100 TABLET in 1 BOTTLE (53746-145-01)	2010-02-18
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Hydrocodone Bitartrate and Ibuprofen combination medications are used primarily for managing moderate to severe pain, often in post-surgical or injury contexts. This analgesic formulation combines an opioid with a non-steroidal anti-inflammatory drug (NSAID), offering dual mechanisms of pain relief. The global demand for such combination drugs has surged amid increased prevalence of chronic pain conditions and regulatory reforms. Consequently, understanding the landscape of suppliers—ranging from active pharmaceutical ingredient (API) producers to finished drug manufacturers—is critical for stakeholders aiming to secure supply chains, negotiate pricing, or assess market risks.

Market Overview and Regulatory Context

Hydrocodone Bitartrate plus Ibuprofen is available under various branded and generic formats. Regulatory authorities such as the U.S. Food and Drug Administration (FDA) strictly control hydrocodone-containing products due to their potential for abuse and addiction. Suppliers must therefore comply with stringent Good Manufacturing Practices (GMP), traceability standards, and comprehensive compliance documentation. The global supply chain includes a mix of domestic and international vendors, with dominant players spanning North America, Asia, and Europe.

Key Suppliers of Hydrocodone Bitartrate

1. Major APIs Manufacturers of Hydrocodone Bitartrate

The core of any hydrocodone-based product is the API, which is predominantly sourced from specialized chemical producers. Notable API suppliers include:

Hubei Yatai Pharmaceutical Co., Ltd. (China): A leading producer of opioid APIs, including hydrocodone bitartrate. The company boasts robust GMP certifications and a global export footprint, primarily supplying North American pharmaceutical firms.
Noramco Inc. (USA): A primary American manufacturer of controlled-substance APIs and intermediates, Noramco supplies hydrocodone APIs to U.S.-based pharmaceutical formulators under strict regulatory scrutiny.
Alkaloids Limited (India): Known for its extensive portfolio of controlled substances, Alkaloids Limited supplies hydrocodone APIs with a focus on compliance with international regulatory standards.
Sun Pharmaceutical Industries (India): While primarily renowned for generic formulations, Sun also produces controlled substance APIs either directly or through partnerships.

2. Asian API Manufacturers

Asia remains a significant hub for controlled substance API production due to cost advantages and manufacturing capacity. Despite regulatory challenges, companies in India, China, and Southeast Asia continue to supply hydrocodone APIs to licensed pharmaceutical entities.

Jilin Jien Biotechnology Co., Ltd. (China): Offers hydrocodone API with GMP certification, primarily serving international markets.
Gansu Yulong Chemical Group (China): An emerging supplier with capacity for controlled substance APIs, including hydrocodone.

3. European API Providers

European companies focus on high-quality API production, often catering to markets with strict regulatory regimes like the EU and North America.

Siegfried AG (Switzerland): Provides controlled substance APIs with high purity standards and comprehensive compliance with international regulations.
Bachem AG (Switzerland): Known for peptide and complex API synthesis, Bachem services include certain controlled substances, positioning as a quality-oriented supplier.

Suppliers of Ibuprofen

Ibuprofen is one of the most widely used NSAIDs, with a well-established global supplier network. The API market for ibuprofen features robust manufacturing capacity, driven by high demand across prescription and OTC markets.

1. Leading API Manufacturers of Ibuprofen

BASF SE (Germany): A dominant global provider of ibuprofen API with extensive manufacturing facilities and strict regulatory compliance.
Ajinomoto Co., Inc. (Japan): Produces high-purity ibuprofen API, mainly serving Asian and global markets.
Shandong Xinhua Pharmaceutical Co., Ltd. (China): One of China’s leading ibuprofen producers, supplying bulk API primarily for export and domestic use.
Sino Biopharm (China): Manufactures and exports large quantities of ibuprofen API compliant with international standards.

2. Brazilian and Indian Manufacturers

Granules India Ltd. (India): Supplies cost-competitive ibuprofen API globally, with certifications meeting WHO-GMP standards.
Aarti Industries Ltd. (India): Offers a comprehensive portfolio of pharmaceutical APIs including ibuprofen, with focus on quality and regulatory approvals.

3. European and North American Suppliers

Sanofi (France): Although better known for formulations, Sanofi maintains API manufacturing, including ibuprofen, with high regulatory oversight.
BASF North America: Provides ibuprofen API to North American pharmaceutical firms, leveraging its quality management systems.

Finished Drug Manufacturers and Contract Manufacturing Organizations (CMOs)

While API supply is vital, finished drug formulation for hydrocodone bitartrate and ibuprofen combinations is handled by a mixture of pharmaceutical firms and CMOs.

Teva Pharmaceutical Industries (Israel): Supplies generic combination formulations of hydrocodone and ibuprofen. Teva’s extensive API sourcing and manufacturing expertise make it a key player.
Mallinckrodt Pharmaceuticals (USA): Markets branded and generic formulations, with a focus on compliance with U.S. regulations.
Contract Manufacturing Organizations (CMOs): Companies such as Catalent, Patheon (part of Thermo Fisher Scientific), and Recipharm manufacture finished dosage forms for various clients under strict regulatory conditions.

Emerging Market Trends and Supply Chain Risks

The global supply chain for hydrocodone Bitartrate and ibuprofen faces challenges including regulatory shifts, geopolitical tensions, and disruption from the COVID-19 pandemic. The tightening controls on controlled substances have driven some manufacturers to diversify supply sources, emphasizing quality, traceability, and compliance.

Regulatory Harmonization: Stricter controls in the U.S. and EU mandate enhanced oversight of API sourcing, especially for hydrocodone, influencing supplier choices.
Shift to Asia: Despite quality concerns, many pharmaceutical companies continue to rely on Asian APIs due to cost competitiveness and manufacturing capacity.
Supply Chain Resilience: Pharmaceutical firms are increasingly adopting dual-sourcing strategies, inventory buffering, and quality audits to mitigate risks.

Key Takeaways

API sourcing is centralized among a handful of high-quality, GMP-compliant manufacturers, primarily in North America, Europe, and Asia.
Hydrocodone Bitartrate suppliers are typically specialized, controlled substance API producers, with strict regulatory oversight to prevent diversion and abuse.
Ibuprofen’s established global manufacturing network enhances supply stability, although price and regulatory compliance influence sourcing decisions.
Manufacturers and pharmaceutical companies must prioritize regulatory compliance, supply chain resilience, and quality assurance amid evolving global and regional regulations governing controlled substances.
Partnerships with trusted API suppliers and robust quality assurance processes remain critical for reliable supply chains, particularly as demand for combination analgesics rises.

FAQs

Q1. What are the primary regulatory considerations when sourcing hydrocodone API?
A: Sourcing hydrocodone API involves compliance with Controlled Substances Act (CSA) regulations in the U.S., GDP standards, and international licensing requirements. Suppliers must possess proper DEA registration, GMP certification, and transparent supply chain documentation to prevent diversion and ensure regulatory compliance.

Q2. How does the international supply chain impact drug formulation availability?
A: Global sourcing introduces risks related to geopolitical tensions, trade restrictions, and regulatory changes. Diversification across regions and rigorous quality audits mitigate potential disruptions and ensure consistent drug availability.

Q3. Are there alternatives to sourcing hydrocodone Bitartrate from traditional suppliers?
A: Alternatives include developing proprietary synthesis methods, sourcing from emerging API manufacturers with GMP certifications, or transitioning to alternative analgesic combinations, although regulatory approval processes can be lengthy.

Q4. What are key considerations for pharmaceutical firms importing ibuprofen APIs?
A: Firms should verify supplier certifications (GMP, ISO), ensure compliance with import regulations, scrutinize purity and batch consistency, and establish robust quality control protocols.

Q5. How has COVID-19 affected supplies of hydrocodone and ibuprofen?
A: The pandemic disrupted manufacturing, transportation, and supply chains, especially in Asia. While ibuprofen experienced increased demand, hydrocodone supply faced challenges due to regulatory closures and manufacturing slowdowns. These disruptions underscored the importance of inventory management and supply diversification.

Sources

[1] U.S. Food and Drug Administration (FDA): Regulations on Controlled Substances Manufacturing.
[2] Global API Market Reports, MarketsandMarkets, 2022.
[3] PharmSource Manufacturers Directory.
[4] European Medicines Agency (EMA) Guidelines on GMP compliance.
[5] Industry publications on API manufacturing capacity and regional trends.

Note: All information is current as of 2023 and subject to change based on regulatory updates and market dynamics.

Suppliers and packagers for HYDROCODONE BITARTRATE AND IBUPROFEN