Bulk Pharmaceutical API Sources for TENUATE DOSPAN

Bulk Pharmaceutical API Sources for TENUATE DOSPAN

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemBridge		5809497
Hangzhou APIChem Technology		AC-16025
AKos Consulting & Solutions		AKOS015962206
Mcule		MCULE-2048650105
MedChemexpress MCE		HY-B0981
AbaChemScene		CS-4472
Clearsynth		CS-T-57146

Bulk Active Pharmaceutical Ingredient (API) Sources for TENUATE DOSPAN

Last updated: July 27, 2025

---

Introduction

Tenuate Dospan, the brand name for the medication containing the active pharmaceutical ingredient (API) diethylpropion hydrochloride, is widely prescribed for short-term management of obesity. The API, diethylpropion hydrochloride, functions as an anorectic agent, stimulating the central nervous system (CNS) to suppress appetite. Ensuring consistent, high-quality API supply is crucial for pharmaceutical manufacturing, regulatory compliance, and market stability. This report highlights the primary sources for bulk diethylpropion hydrochloride, considering global manufacturing landscapes, regulatory considerations, and supply chain dynamics pertinent to Tenuate Dospan production.

---

Overview of Diethylpropion Hydrochloride as an API

Diethylpropion hydrochloride is a sympathomimetic amine chemically classified as a phenylpropylamine derivative. It acts centrally by elevating norepinephrine levels, thereby reducing hunger sensations. Approved in various markets like the US and Europe, its manufacturing involves complex chemical synthesis processes that demand rigorous quality control, including specifications for potency, purity, and residual impurities.

---

Market Landscape for API Supply

The API supply chain for diethylpropion hydrochloride is concentrated among select regional and global manufacturers. These entities vary in production capacity, regulatory compliance, and geographic distribution. Currently, the API's visibility in the pharmaceutical market is limited compared to blockbuster compounds, resulting in fewer specialized suppliers.

---

Major API Manufacturers for Tenuate Dospan

1. Domestic U.S. Manufacturers

a. Teva Pharmaceutical Industries

• Profile: One of the world's largest generic drug manufacturers, Teva produces a wide portfolio of APIs, including CNS agents.
• API Production: Teva's integrated manufacturing facilities in Israel and the United States focus on high-quality APIs conforming to cGMP standards.
• Supply Capabilities: Capable of supplying diethylpropion hydrochloride in bulk quantities, primarily for US-based markets.

b. Contract Manufacturing Organizations (CMOs)

• Several U.S.-based CMOs, such as Cambrex and Patheon (a business of Thermo Fisher), have capabilities to produce custom APIs, including stability-validated diethylpropion hydrochloride.

2. Asian API Producers

a. Zhejiang Kangle Pharmaceutical Co., Ltd. (China)

• Interest: A prominent Chinese API manufacturer with an established reputation for CNS-active compounds.
• Capabilities: Offers diethylpropion hydrochloride conforming to international standards, providing cost-effective bulk supplies for global markets.

b. Zhejiang Hisun Pharmaceutical Co., Ltd.

• Profile: A major player in China’s API industry, with diversified portfolio including sympathomimetic agents.
• Production: Demonstrates compliance with current Good Manufacturing Practices (cGMP) and offers export-ready API.

c. Wuxi AppTec

• Wuxi AppTec’s API division specializes in chemical synthesis for CNS drugs, with capacity for diethylpropion hydrochloride. Their streamlined supply chain supports global export.

3. Indian API Manufacturers

a. Hetero Labs

• Overview: Known for large-scale synthesis of CNS APIs, Hetero Labs supplies diethylpropion hydrochloride to generic and branded pharmaceutical companies.
• Compliance: Adheres to strict quality standards, including WHO-GMP certifications.

b. Divis Laboratories

• Profile: An established API producer with a focus on complex molecules, including sympathomimetics.
• Supply: Capable of bulk API supply with internationally recognized quality certifications.

---

Regulatory Considerations in API Sourcing

When sourcing diethylpropion hydrochloride for Tenuate Dospan manufacturing, compliance with regulatory standards such as FDA, EMA, and WHO guidelines is essential. Buyers prioritize suppliers with recent audits, validated manufacturing processes, and comprehensive dossiers including Drug Master Files (DMFs).

Many suppliers in regions like China and India have made strides toward regulatory compliance, but buyers must verify cGMP adherence and obtain proper documentation to avoid delays and compliance issues.

---

Supply Chain Challenges and Trends

• Quality Assurance: Ensuring API purity, potency, and residual solvent levels per pharmacopeial standards remains paramount.
• Manufacturing Capacity: The limited number of producers active in CNS-active APIs like diethylpropion hydrochloride constrains supply flexibility.
• Pricing Dynamics: Cost-effective sourcing often comes from Asian manufacturers, but geopolitical and regulatory factors influence stability.
• Global Disruptions: COVID-19 pandemic underscored vulnerabilities within API supply chains, prompting diversification efforts and inventory management strategic shifts.

---

Emerging Sources and Technological Innovations

• Custom Synthesis Providers: Increasingly, pharmaceutical companies engage high-capacity Contract Development and Manufacturing Organizations (CDMOs) with proprietary synthesis methods that guarantee supply security.
• Green Chemistry Advances: Innovations in synthesis techniques aim to reduce waste and improve yield, potentially expanding production capacity and quality.

---

Conclusion

The primary sources for bulk diethylpropion hydrochloride encompass a select set of regional and global manufacturers, with a notable concentration in China, India, and North America. For pharmaceutical companies producing Tenuate Dospan, supplier selection hinges on regulatory compliance, manufacturing capacity, quality standards, and geopolitical stability. Building a diversified supplier portfolio aligned with current global standards remains essential to maintaining uninterrupted supply channels.

---

Key Takeaways

• Suppliers like Zhejiang Kangle, Zhejiang Hisun, Wuxi AppTec, Hetero Labs, and Divis Laboratories dominate the diethylpropion hydrochloride API landscape.
• Regulatory compliance, including cGMP certification and DMF filings, is critical for successful procurement.
• Asian manufacturers offer cost-effective bulk supplies, but due diligence regarding quality and regulatory track record is necessary.
• Supply chain resilience can be enhanced through diversified sourcing and strategic agreements with reputable vendors.
• Advances in green chemistry and process innovation present opportunities for future API supply stability and quality improvements.

---

FAQs

1. What are the key quality standards for sourcing diethylpropion hydrochloride APIs?
Ensuring API suppliers comply with cGMP, possess up-to-date DMFs, and meet pharmacopeial specifications for purity, potency, and residual solvents is essential.

2. How does geographic diversification impact API supply stability for Tenuate Dospan?
Diversifying sources across regions like China, India, and North America mitigates risks from regional disruptions, regulatory changes, and market fluctuations.

3. Are there alternative APIs or formulations that can replace diethylpropion hydrochloride?
While other sympathomimetics exist, diethylpropion remains the primary API due to its efficacy and established safety profile. Substitutions would require regulatory approval.

4. What are the major regulatory hurdles in importing diethylpropion hydrochloride APIs?
Regulatory hurdles include securing proper CMC documentation, compliance with import/export controls, and adherence to health authority standards such as FDA's drug master file requirements.

5. How might future innovations influence API sourcing strategies?
Process innovations, green chemistry advancements, and scalable synthetic routes could enhance API quality, reduce costs, and expand manufacturing capacity, positively affecting sourcing strategies.

---

Sources Cited

1. U.S. Food and Drug Administration (FDA). Drug Master Files (DMFs). Available at [FDA website].
2. European Medicines Agency (EMA). Guidelines on the chemical and pharmaceutical quality documentation for select API manufacturing sites.
3. Zhejiang Kangle Pharmaceutical Co., Ltd. Product datasheets and certifications.
4. Wuxi AppTec. API manufacturing capabilities overview.
5. Hetero Labs. API portfolio and compliance information.