HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abhai Llc	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	207487	ANDA	KVK-Tech, Inc.	10702-150-16	473 mL in 1 BOTTLE (10702-150-16)	2017-02-21
Actavis Mid Atlantic	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	088017	ANDA	Actavis Pharma, Inc.	0472-1030-16	473 mL in 1 BOTTLE (0472-1030-16)	2002-09-30
Novel Labs Inc	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	203535	ANDA	Novel Laboratories, Inc.	40032-810-05	473 mL in 1 BOTTLE (40032-810-05)	2017-02-13
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 8, 2025

ppliers for the Pharmaceutical Drug: Hydrocodeone Bitartrate and Homatropine Methylbromide

Introduction

Hydrocodone Bitartrate and Homatropine Methylbromide constitute a pharmaceutical compound primarily used for specific analgesic and antispasmodic applications. Due to the complexities of sourcing such controlled substances, understanding the global and regional suppliers is crucial for pharmaceutical companies, healthcare providers, and regulatory bodies. This article offers a comprehensive analysis of key suppliers, supply chain considerations, and industry trends relevant to these drugs.

Regulatory Context and Market Overview

Hydrocodone Bitartrate, an opioid analgesic, and Homatropine Methylbromide, an anticholinergic agent, are classified under controlled substances due to their pharmacological effects and abuse potential. Their manufacturing and distribution are heavily regulated under international conventions such as the Single Convention on Narcotic Drugs (1961) and regional laws, including US Drug Enforcement Administration (DEA) guidelines.

The global market for hydrocodone-based medications is concentrated among a limited number of licensed manufacturers, primarily within North America, Europe, and select Asian countries. Homatropine Methylbromide, although less regulated, is produced by specialized chemical and pharmaceutical suppliers with stringent quality standards.

Major Suppliers of Hydrocodone Bitartrate

1. Purdue Pharma

Overview: As a pioneering entity in opioid manufacturing, Purdue Pharma has historically supplied hydrocodone products, including Bitartrate formulations, in the United States and internationally.
Supply Chain Role: Purdue's extensive manufacturing capabilities and controlled distribution networks make it a critical supplier, though it faces legal and regulatory challenges that impact supply stability.

2. Mallinckrodt Pharmaceuticals

Overview: A prominent manufacturer of controlled substances, Mallinckrodt produces hydrocodone products for medical use, including formulations containing Hydrocodone Bitartrate.
Supply Chain Role: Their Global manufacturing facilities ensure consistent supply, especially to North American markets.

3. Hikma Pharmaceuticals

Overview: Based in Jordan, Hikma is a key supplier of generic opioids, including hydrocodone Bitartrate, catering to markets in the Middle East, Europe, and North America.
Regulatory Considerations: Their manufacturing complies with international standards such as GMP, ensuring quality and regulatory acceptance globally.

4. Teva Pharmaceutical Industries

Overview: Jews of patent and generic medications, Teva supplies hydrocodone Bitartrate in several markets, primarily as a generic producer.
Global Reach: Their extensive distribution network adds to the drug's availability.

5. Zhejiang Hanghai Pharmaceuticals

Overview: Based in China, the company produces bulk hydrocodone intermediates for export to authorized manufacturers worldwide.
Supply Chain Significance: Chinese producers serve as key raw material suppliers, although regulatory hurdles often influence their market access.

Sources of Homatropine Methylbromide

1. Merck KGaA

Overview: Historically, Merck has produced Homatropine Methylbromide for ophthalmic and antispasmodic applications.
Supply Dynamics: Their quality standards and global presence make them a preferred supplier in regulated markets.

2. Sandoz (Novartis)

Overview: Sandoz supplies a broad portfolio of active pharmaceutical ingredients, including Homatropine Methylbromide, primarily serving generic pharmaceutical manufacturers.
Market Penetration: Their focus on high-quality APIs ensures compliance and consistent product availability.

3. Localized Chemical Suppliers

Overview: Several regional suppliers in India, China, and Eastern Europe produce Homatropine Methylbromide, often supplying to larger multinational pharmaceutical companies.
Regulatory Hurdles: Due to the drug’s specificity, sourcing from these suppliers necessitates rigorous quality assurance and regulatory validation.

Supply Chain Considerations

Regulatory Compliance

Given the controlled status of hydrocodone, suppliers must maintain strict adherence to international and local narcotic control laws, including licensing, security measures, and traceability. Non-compliance risks severe legal penalties and supply disruptions.

Raw Material Sourcing

Hydrocodone Bitartrate production hinges on the availability of precursor chemicals such as codeine or thebaine, primarily sourced from opium poppy cultivation regions (Australia, Turkey, India). The supply of Homatropine Methylbromide depends on the procurement of specific chemical intermediates.

Manufacturing Quality Standards

Suppliers must adhere to Good Manufacturing Practice (GMP) standards, especially for injectable and oral formulations. Certification from agencies such as the FDA, EMA, or GMP compliance certificates from the World Health Organization (WHO) are essential.

Geopolitical and Regulatory Risks

Trade restrictions, export bans, and changing narcotic regulations can influence the supply trajectory, particularly affecting regions with evolving policies like China and India.

Emerging Trends and Industry Dynamics

Growing Demand for Generic Analgesics: Patent expirations and patent cliffs drive demand for generic hydrocodone API sourcing from multiple suppliers globally.
Regulatory Tightening: Increased oversight by authorities aims to curtail diversion and misuse, impacting manufacturing and distribution channel choices.
Supply Chain Diversification: Companies increasingly diversify sourcing to mitigate risks associated with regional regulations, manufacturing disruptions, or geopolitical tensions.
Shift Toward Biosimilars and Alternatives: Some markets look for non-opioid alternatives, potentially reducing future demand for hydrocodone-based products.

Conclusion

Sourcing Hydrocodone Bitartrate and Homatropine Methylbromide involves navigating complex regulatory environments, ensuring rigorous quality standards, and aligning supply chain strategies with global demand. Key suppliers like Purdue Pharma, Mallinckrodt, Hikma, and Merck dominate their respective markets, though geopolitical and legal factors continually reshape the landscape. For businesses, diversifying supplier bases, maintaining regulatory compliance, and monitoring geopolitical developments are crucial for securing resilient supply chains.

Key Takeaways

The supply of hydrocodone Bitartrate relies heavily on a limited number of licensed manufacturers, with geographic concentration in North America, Europe, and Asia.
Homatropine Methylbromide suppliers predominantly include multinational chemical companies and regional API producers with strong quality assurance protocols.
Regulatory compliance, especially with narcotics laws, is essential for supply continuity and legality.
Diversification of suppliers and regions mitigates risks associated with geopolitical pressures and market disruptions.
Evolving demand patterns and increasing regulation emphasize the need for proactive supply chain management and compliance strategies.

FAQs

1. Who are the main manufacturers of Hydrocodone Bitartrate globally?
Major manufacturers include Purdue Pharma, Mallinckrodt Pharmaceuticals, Hikma Pharmaceuticals, and Teva Pharmaceutical Industries, primarily operating in North America, Europe, and the Middle East.

2. Is Homatropine Methylbromide widely available from multiple suppliers?
While several multinational companies like Merck and Sandoz produce Homatropine Methylbromide, regional chemical suppliers also serve as sources, though regulatory validation remains critical.

3. What challenges do companies face in sourcing controlled substances like Hydrocodone Bitartrate?
Key challenges include strict regulatory requirements, limited supplier base, geopolitical risks, and supply chain disruptions due to law enforcement crackdowns and import-export restrictions.

4. How do geopolitical factors influence the supply chain of these drugs?
Trade bans, export controls, and political instability in key raw material regions can lead to supply shortages, enforcing the need for supply chain diversification and strategic stockpiling.

5. Are there any recent industry trends affecting suppliers of these drugs?
Yes, trends include increasing regulation, demand for generic alternatives, and a shift towards non-opioid pain management options, all influencing supplier strategies and market stability.

Sources

[1] International Narcotics Control Board (INCB), "Report on Narcotic Drugs" (2022).
[2] U.S. Drug Enforcement Administration (DEA), "Controlled Substance Schedules," (2023).
[3] European Medicines Agency (EMA), "Quality of Medicines," (2022).
[4] GlobalData Pharma Intelligence, "API Supply Chain Report," (2023).
[5] Industry publications and company websites, including Purdue Pharma, Mallinckrodt, Hikma, Merck, and Sandoz.

This detailed overview facilitates informed decision-making for stakeholders involved in the procurement, regulation, and supply chain management of Hydrocodone Bitartrate and Homatropine Methylbromide.

Suppliers and packagers for HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE