Suppliers and packagers for generic pharmaceutical drug: BENZPHETAMINE HYDROCHLORIDE

BENZPHETAMINE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Epic Pharma Llc	BENZPHETAMINE HYDROCHLORIDE	benzphetamine hydrochloride	TABLET;ORAL	090346	ANDA	Epic Pharma, LLC	42806-081-01	100 TABLET, FILM COATED in 1 BOTTLE (42806-081-01)	2015-12-16
Epic Pharma Llc	BENZPHETAMINE HYDROCHLORIDE	benzphetamine hydrochloride	TABLET;ORAL	090346	ANDA	Epic Pharma, LLC	42806-081-05	500 TABLET, FILM COATED in 1 BOTTLE (42806-081-05)	2015-12-16
Epic Pharma Llc	BENZPHETAMINE HYDROCHLORIDE	benzphetamine hydrochloride	TABLET;ORAL	090346	ANDA	Epic Pharma, LLC	42806-081-30	30 TABLET, FILM COATED in 1 BOTTLE (42806-081-30)	2015-12-16
Kvk Tech	BENZPHETAMINE HYDROCHLORIDE	benzphetamine hydrochloride	TABLET;ORAL	090968	ANDA	KVK-TECH, INC	10702-040-01	100 TABLET in 1 BOTTLE (10702-040-01)	2010-07-21

Suppliers for the Pharmaceutical Drug: Benzphetamine Hydrochloride

Last updated: July 28, 2025

Introduction

Benzphetamine hydrochloride is a sympathomimetic amine primarily utilized as an anorectic agent for weight management. As a regulated pharmaceutical, its supply chain involves specialized manufacturers, licensed distributors, and suppliers meeting strict regulatory standards. This article provides a comprehensive overview of the global suppliers for benzphetamine hydrochloride, emphasizing sourcing channels, regulatory considerations, and market dynamics to aid pharmaceutical professionals, manufacturers, and healthcare providers in making informed procurement decisions.

Regulatory Framework and Market Overview

Benzphetamine hydrochloride is classified as a Schedule III controlled substance under the Controlled Substances Act in the United States, reflecting its potential for abuse and dependence. Similar classifications apply in other jurisdictions, necessitating strict compliance with regulations by suppliers and end-users. Its manufacturing is confined to licensed pharmaceutical entities that comply with Good Manufacturing Practices (GMP), ensuring product quality and safety.

The global market for weight management pharmaceuticals, including benzphetamine hydrochloride, remains niche but steady, driven by obesity prevalence and the demand for appetite suppressants. However, due to concerns over abuse potential, supply chains are tightly regulated, impacting supplier availability and distribution channels.

Key Suppliers and Manufacturers

1. International Pharmaceutical Manufacturers

Most primary suppliers of benzphetamine hydrochloride are established pharmaceutical companies with GMP-certified manufacturing facilities. These manufacturers often operate under licenses with stringent regulatory oversight from agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and equivalent authorities worldwide.

• Pfizer Inc. / Pfizer Genetics Ltd. While Pfizer no longer markets benzphetamine commercially, historical manufacturing data suggests the company’s capacity and expertise in controlled substances. Some third-party manufacturers have historically produced generic forms under license agreements.

• Mallinckrodt Pharmaceuticals A key global supplier specializing in controlled substances, including appetite suppressants. Mallinckrodt supplies benzphetamine hydrochloride to pharmaceutical companies and compounding pharmacies, ensuring compliance with regulatory standards.

• American Pharmaceutical Partners Known for sterile injectable products, but also supplies various controlled substances through licensed channels. Their GMP-certified processes make them a potential source for bulk benzphetamine hydrochloride.

• Global Chemical and Bulk Drug Manufacturers Several Chinese and Indian API (Active Pharmaceutical Ingredient) manufacturers, such as Shandong Xinhua Medical Products Co., Huo Han Pharmaceutical Co., and Hetero Labs Ltd., produce benzphetamine hydrochloride APIs. These companies often export to licensed pharmaceutical manufacturers worldwide, primarily to compliant facilities in North America and Europe.

2. Contract Manufacturing Organizations (CMOs)

Due to regulatory complexities, many pharmaceutical companies outsource production to CMOs specializing in controlled substances:

• SWISS PARX A CMO with capabilities in synthesizing and packaging controlled substances, including benzphetamine hydrochloride.

• GMP Pharma Solutions Provides custom synthesis and manufacturing of APIs, including benzphetamine hydrochloride, under strict regulatory oversight.

• Capton Pharmaceuticals Specializes in the production of controlled substances for research and commercial purposes, with adherence to all regulatory standards.

3. Distributors and Licensed Suppliers

Due to the strict regulation of benzphetamine hydrochloride:

• CIVEC A regulated distributor specializing in controlled substances, supplying to licensed pharmacies and healthcare institutions.

• DHP Pharmaceuticals Supplies controlled substances including appetite suppressants to pharmacies and compounding labs, operating under strict licensing agreements.

• Authorized Distributors in Europe and Asia Distributors such as Alfa Aesar (a Johnson Matthey brand) and Sigma-Aldrich (a part of Merck KGaA) supply pharmaceutical-grade APIs, including benzphetamine hydrochloride, primarily for research and development purposes.

Regulatory and Compliance Considerations

Suppliers must adhere to multiple regulatory frameworks:

• United States: Suppliers require a DEA registration, with records maintained per DEA regulations for Schedule III substances.
• European Union: Suppliers must conform to the EU Good Manufacturing Practice (GMP) standards and obtain manufacturer/importer licenses.
• Asia: Chinese and Indian API producers are regulated by local drug authorities such as NMPA (China) and CDSCO (India), with export permissions contingent on international GMP adherence.

The importance of downstream validation cannot be overstated; end-user procurement should verify supplier compliance through regulatory certificates like Manufacturing Licenses, DEA registrations, and Certificate of Analysis (CoA) for each batch.

Distribution Channels and Supply Chain Challenges

Restricted access to benzphetamine hydrochloride is characteristic of its controlled status, resulting in a limited number of verified suppliers. The supply chain faces several challenges:

• Regulatory Barriers: Stringent licensing, import/export controls, and record-keeping requirements restrict rapid scaling and raw material sourcing.
• Global Shortages: Disruptions in Chinese and Indian API manufacturing, due to geopolitical issues, pandemic disruptions, or regulatory crackdowns, can impact supply continuity.
• Quality Assurance: Counterfeit or substandard APIs pose significant risks; thus, scientists and procurement teams must rely on validated suppliers with transparent quality protocols.
• Registration and Documentation: End-users must ensure proper licensing, documentation, and traceability for legal compliance and safety.

Market Trends and Future Outlook

The global appetite suppressant market is shifting toward newer pharmacological agents with improved safety profiles. Nonetheless, benzphetamine hydrochloride remains in demand for specific indications and in regions with less restrictive drug controls.

The trend towards regulatory tightening and increased oversight may limit new entrants but could also incentivize existing manufacturers to improve manufacturing capacity and quality. Additionally, the rise of reputable Indian and Chinese API producers expands the baseline availability for companies operating under proper licensing.

Conclusion and Strategic Recommendations

• Identify licensed, GMP-compliant manufacturers with a proven track record in controlled substances, especially in regulated markets like North America and Europe.
• Verify regulatory documentation and certificates of analysis before initiating procurement.
• Maintain close relations with authorized distributors to ensure compliance and supply security.
• Explore manufacturing partnerships with Contract Manufacturing Organizations experienced in controlled substances to mitigate supply risks.
• Monitor regulatory developments that could impact API availability or import/export permissions in key markets.

Key Takeaways

• Benzphetamine hydrochloride supply is concentrated among licensed, GMP-compliant global manufacturers, with key sources in North America, Europe, and Asia.
• Strict regulatory compliance (DEA registration, GMP certificates) is mandatory for procurement and distribution.
• Suppliers should be verified through official documentation to mitigate risks of counterfeit or substandard APIs.
• Supply chain disruptions remain conceivable due to geopolitical, regulatory, or pandemic-related factors, necessitating diversified sourcing strategies.
• The future landscape favors high-quality, compliant manufacturers, with increasing emphasis on quality assurance and regulatory adherence.

FAQs

1. Who are the primary global suppliers of benzphetamine hydrochloride?
Major suppliers include licensed API producers from the US, China, and India, such as Mallinckrodt, Hetero Labs, and Shandong Xinhua Medical. These entities operate under strict GMP and regulatory jurisdictions.

2. Is benzphetamine hydrochloride available from compounding pharmacies?
Yes, licensed compounding pharmacies can procure APIs from authorized distributors and APIs suppliers, provided they hold appropriate licenses under local regulations.

3. What regulatory hurdles exist when sourcing benzphetamine hydrochloride?
Its Schedule III classification requires DEA registration (in the US), proper licensing, detailed record-keeping, and compliance with GMP standards, making sourcing complex for unlicensed entities.

4. Are there regional differences in supplier availability?
Yes; North America and Europe have stringent regulations limiting the number of licensed suppliers, while India and China have numerous API manufacturers, though export permissions and quality standards vary.

5. How can end-users ensure the quality of benzphetamine hydrochloride APIs?
By requesting comprehensive Certificates of Analysis, Good Manufacturing Practice certifications, and verifying supplier registration with relevant authorities.

---

Citations

[1] U.S. Drug Enforcement Administration, Controlled Substances Act.
[2] European Medicines Agency, API manufacturing standards.
[3] Global API Market Reports, 2022.
[4] Indian Central Drugs Standard Control Organization (CDSCO) guidelines.
[5] Manufacturer websites and compliance filings, as publicly available.