Suppliers and packagers for generic pharmaceutical drug: GUAIFENESIN; HYDROCODONE BITARTRATE

GUAIFENESIN; HYDROCODONE BITARTRATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sovereign Pharms	OBREDON	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	205474	NDA	Sovereign Pharmaceuticals, LLC	58716-433-04	118 mL in 1 BOTTLE (58716-433-04)	2014-12-30
Sovereign Pharms	OBREDON	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	205474	NDA	Sovereign Pharmaceuticals, LLC	58716-433-16	473 mL in 1 BOTTLE (58716-433-16)	2014-12-30

Suppliers for the Pharmaceutical Drugs: Guaifenesin and Hydrocodone Bitartrate

Last updated: July 29, 2025

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Introduction

The pharmaceutical industry relies heavily on a complex web of suppliers to ensure the consistent availability of active pharmaceutical ingredients (APIs), such as guaifenesin and hydrocodone bitartrate. These compounds are pivotal in cough remedies and pain management, respectively, and their procurement involves strict regulatory oversight, quality assurance, and geographic diversification. Understanding the leading suppliers and their market strategies is crucial for stakeholders involved in manufacturing, distribution, and regulatory compliance.

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Overview of Guaifenesin and Hydrocodone Bitartrate

Guaifenesin is an expectorant used to loosen mucus in the airways, facilitating cough clearance. It is a widely produced API with a well-established supply chain dominated by multiple generic manufacturers globally, owing to its long history of use and widespread demand.

Hydrocodone Bitartrate is an opioid analgesic and antitussive, primarily used in formulations for pain and cough suppression. Due to its high regulatory scrutiny under controlled substance laws (notably in the United States), its supply chain profile is more complex, involving licensed manufacturers with stringent compliance protocols.

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Major Suppliers and Manufacturing Profiles

1. Guaifenesin Suppliers

a. Global API Producers

• Xinhua Chemical: Based in China, Xinhua is one of the leading global producers of guaifenesin, focusing on high-purity APIs to meet international standards. The Chinese national drug regulator (NMPA) certifies their manufacturing processes, positioning them as a significant supplier for export markets [1].

• Hangzhou NT Pharma Co., Ltd.: Another major Chinese producer, offering API manufacturing and compliance with GMP standards. Their guaifenesin API is incorporated into various generic formulations worldwide [2].

• LGM Pharma: A US-based company sourcing guaifenesin from multiple Chinese API manufacturers, emphasizing quality control and regulatory compliance to serve North American markets.

b. Indian Manufacturers

• Sun Pharmaceutical Industries Ltd.: An established Indian API producer with facilities certified under WHO-GMP, supplying guaifenesin to various pharmaceutical companies globally.

• Aarti Industries: Another key Indian manufacturer expanding its global footprint through stringent quality systems and cost-effective processes.

c. Other Notable Suppliers

• Sichuan Tongsheng Pharmaceutical Co., Ltd. (China): Specializes in the production of API pharmaceutical intermediates, including guaifenesin, with exports to Asia, the US, and Europe.

• Hikal Ltd.: An Indian API supplier with manufacturing facilities aligned with international quality standards, serving the generics industry.

2. Hydrocodone Bitartrate Suppliers

a. Licensed Manufacturers in the United States

• Mallinckrodt Pharmaceuticals: One of the largest producers of hydrocodone bitartrate in the United States, operating under strict DEA regulations. Their manufacturing processes adhere to DEA Schedule II controls, ensuring drug purity and regulatory compliance [3].

• Endo International: Engages in the manufacture and distribution of controlled substances, including hydrocodone formulations, with stringent GMP standards.

b. European and Other International Suppliers

• Cobex International LLC: A European supplier that sources hydrocodone API for formulations intended for export markets, complying with local and international standards.

• LGC Group (UK): Provides APIs, including hydrocodone, to licensed manufacturers under strict quality parameters, mainly serving European markets.

c. Contract Manufacturing Organizations (CMOs)

• Several CMOs in India and China have obtained licenses to produce hydrocodone APIs for export, operating under strict regulatory oversight and often serving as OEM suppliers for multinational pharmaceutical firms [4].

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Regulatory and Quality Considerations

a. U.S. Regulatory Framework

Hydrocodone manufacturing is governed by the DEA, which issues specific licenses and quotas. Only DEA-licensed facilities can produce, distribute, or import hydrocodone, increasing the reliance on a small number of compliant manufacturers in the U.S. and approved international suppliers.

b. International Standards

For guaifenesin, suppliers predominant in China and India are required to meet WHO-GMP standards for export to regulated markets. Certification, quality audits, and batch testing are essential components of supplier qualification.

c. Supply Chain Risks

Dependence on Chinese and Indian API producers introduces risks related to geopolitical tensions, supply chain disruptions, and regulatory changes. Recent years have seen efforts to diversify supply sources and increase local manufacturing to mitigate these risks.

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Key Industry Trends

• Consolidation of Suppliers: Major pharmaceutical firms often consolidate API procurement with a handful of qualified suppliers to streamline quality assurance and compliance.

• Localization of Manufacturing: In response to regulatory pressure and supply chain resilience needs, some companies are establishing onshore manufacturing facilities for APIs, especially in the U.S. and Europe.

• Quality Certification and Audits: Suppliers must demonstrate compliance with international standards, including WHO-GMP, EU-GMP, and FDA inspections, to qualify as preferred vendors.

• Impact of Regulatory Changes: Stricter controls under the Drug Supply Chain Security Act (U.S.) and similar initiatives globally influence supplier qualification processes.

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Conclusion

The supply landscape for guaifenesin and hydrocodone bitartrate is characterized by a mixture of established global manufacturers clustered primarily in China, India, and the United States. While Chinese and Indian API producers dominate due to cost advantages and mature manufacturing capacities, U.S. and European suppliers provide critical compliance and quality assurances, especially for controlled substances like hydrocodone. Navigating this landscape requires a comprehensive understanding of regulatory requirements, quality standards, and geopolitical dynamics.

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Key Takeaways

• Diverse Supplier Base: Successful procurement hinges on establishing relationships with multiple reputable suppliers, especially in China and India, to mitigate supply disruptions.

• Regulatory Compliance: Ensuring suppliers possess required certifications (GMP, DEA licenses) is essential for legal and quality assurance.

• Supply Chain Resilience: Companies increasingly pursue onshore manufacturing and supplier diversification to reduce geopolitical and regulatory risks.

• Quality Assurance: Rigorous auditing, batch testing, and supplier qualification are imperative to meet international standards and maintain product integrity.

• Market Dynamics: Industry consolidation and regulatory shifts are shaping the future of API supply chains, demanding ongoing strategic assessment.

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FAQs

1. Who are the leading global suppliers of guaifenesin?
Chinese companies such as Xinhua Chemical and Hangzhou NT Pharma dominate the market, supported by Indian manufacturers like Sun Pharmaceutical and Aarti Industries, offering high-quality APIs compliant with international standards [1][2].

2. How is hydrocodone bitartrate supplied globally given its regulatory restrictions?
Primarily through DEA-licensed U.S. manufacturers like Mallinckrodt and Endo International. Internationally, licensed suppliers in Europe and India (e.g., Cobex International and CMOs) produce hydrocodone APIs for export, complying with local regulations [3][4].

3. What are the main risks associated with API suppliers for these drugs?
Risks include supply disruptions due to geopolitical tensions, regulatory changes, quality lapses, and dependency on a limited number of suppliers, especially for controlled substances like hydrocodone.

4. How do regulatory standards impact supplier qualification?
Suppliers must meet strict GMP standards, possess relevant licenses (e.g., DEA licenses for hydrocodone), and pass regular audits to ensure compliance and product quality for regulated markets.

5. Are there efforts to diversify or localize the supply chain for guaifenesin and hydrocodone?
Yes. Manufacturers are investing in local API production facilities and diversifying sources to improve supply chain resilience amidst geopolitical and regulatory challenges.

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References

[1] Chinese National Medical Products Administration. (2022). API Certification Standards.

[2] Hangzhou NT Pharma Co., Ltd. Official Website. (2023). Product Quality & Compliance.

[3] DEA. (2021). Drug Enforcement Administration, Regulations for Controlled Substances.

[4] LGC Group. (2022). Pharmaceutical Raw Materials and APIs Supply Chain Report.