Bulk Pharmaceutical API Sources for UNISOM

Bulk Pharmaceutical API Sources for UNISOM

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D3775_SIGMA
Molport		MolPort-003-666-172
Hangzhou APIChem Technology		AC-4487
Finetech Industry Limited		FT-0625595
AbaChemScene		CS-3232

Bulk Active Pharmaceutical Ingredient (API) Sources for UNISOM

Last updated: July 30, 2025

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Introduction

Unisom, a widely recognized over-the-counter medication primarily used for short-term insomnia relief, contains active pharmaceutical ingredients (APIs) that induce sedative effects. The most common APIs in Unisom are diphenhydramine and doxylamine, both classified as antihistamines with sedative properties. The sourcing of these APIs involves a complex supply chain, with numerous manufacturers contributing to global distribution. Ensuring reliable, high-quality API sources is essential for pharmaceutical companies, regulatory compliance, and product consistency.

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Overview of API Components in Unisom

Diphenhydramine Hydrochloride

• Chemically classified as an antihistamine, diphenhydramine is the primary API in many Unisom formulations. It acts centrally to suppress histamine, producing sedative effects that facilitate sleep.

Doxylamine Succinate

• Doxylamine is another first-generation antihistamine with potent sedative qualities, frequently present in sleep aids marketed as Unisom Sleep Tabs.

Both APIs are subject to rigorous regulatory standards, requiring manufacturers to adhere to Good Manufacturing Practices (GMP) and obtain approvals from agencies such as the FDA, EMA, or equivalent authorities.

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Key Sources of API for Unisom

1. Major API Manufacturers and Suppliers

The global API supply landscape is dominated by a handful of large, established manufacturers with extensive manufacturing capacities, quality standards, and regulatory compliance infrastructure. These key suppliers include:

• Hovione
  A Portuguese API manufacturer with capabilities in both synthesis and formulation intermediates. Hovione supplies diphenhydramine to global markets, ensuring adherence to international GMP standards.

• Taj Pharmaceuticals
  An Indian API producer with extensive experience in antihistamines, offering diphenhydramine and doxylamine with regulatory approvals suitable for international markets.

• Shanghai Pharmaceutical (Group) Co., Ltd.
  A leading Chinese company supplying high-quality APIs, including diphenhydramine, leveraging advanced manufacturing facilities that meet WHO GMP standards.

• Prakash Chemicals International
  Based in India, specializing in antihistamines and sedatives, with a comprehensive portfolio including diphenhydramine and doxylamine.

• Xinbai Pharmaceuticals
  A prominent Chinese API manufacturer offering multiple antihistamines, with exports to North America, Europe, and Asia.

2. Regional API Producers

Regional suppliers are often engaged for regional market needs or as secondary sources:

• Sino Biopharmaceutical Limited
  Chinese manufacturer noted for compliance with GMP standards and supplying diphenhydramine to Asian markets.

• Divi's Laboratories
  Indian company with a robust API portfolio, including sedatives and antihistamines, serving South Asian and international clients.

• Retkem Chemie
  German-based company providing specialty chemicals and APIs, including certain antihistamines, for European and global markets.

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Emerging and Contract Manufacturing Organizations (CMOs)

Contract development and manufacturing organizations (CDMOs) have become increasingly pivotal, offering scalable API production:

• BASF
  The German chemical giant supplies custom and generic APIs, with capabilities in large-scale synthesis of antihistamines.

• Pharmaceutical Product Development (PPD)
  A recognized CMO providing API manufacturing tailored to client specifications, including diphenhydramine and doxylamine.

• Almac Group
  UK-based CDMO with early-phase to commercial API manufacturing, known for consistent quality and regulatory expertise.

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Criteria for API Source Selection

When sourcing APIs, pharmaceutical companies prioritize several key factors:

• Regulatory Compliance: Suppliers must possess licenses such as FDA ANDA, DMF, or equivalent certifications. Good Manufacturing Practices (GMP) are non-negotiable.

• Quality and Purity: High-grade APIs with minimal residual solvents, impurities, and specification adherence.

• Capacity and Lead Time: Suppliers must meet demand forecasts without supply disruptions.

• Cost and Logistics: Competitive pricing while ensuring reliable distribution channels.

• Traceability: Transparent supply chain documentation for audits and compliance.

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Supply Chain Challenges and Considerations

• Regulatory Variability: Diverse global standards can complicate sourcing, especially for companies aiming for international distribution.

• Geopolitical Factors: Tariffs, export restrictions, or political instability in supplier regions (notably China and India) can impact supply continuity.

• Supply Chain Transparency: Increasing regulatory focus on supply chain traceability incentivizes partnerships with suppliers who provide comprehensive documentation and testing reports.

• Quality Assurance: Cross-contamination, batch consistency, and impurity profiles demand rigorous supplier qualification procedures.

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Future Outlook for API Sourcing in Unisom

• Localization Trends: Shift towards regional API production, driven by trade policies and supply chain resilience initiatives, may diversify supplier bases.

• Regulatory Harmonization: Growing international standards will streamline sourcing processes, reducing variation and enhancing product safety.

• Supply Chain Digitization: Enhanced transparency through blockchain and integrated quality management systems will reduce risks associated with counterfeit APIs and quality lapses.

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Key Takeaways

• The primary APIs in Unisom, diphenhydramine, and doxylamine, are sourced globally, predominantly from India, China, and European manufacturers.

• Leading API suppliers such as Hovione, Taj Pharmaceuticals, Shanghai Pharmaceutical, and Divi’s Laboratories play dominant roles in fulfilling global demand.

• Regulatory compliance, quality assurance, and supply reliability are critical when selecting API sources for Unisom.

• The industry is shifting towards regional production and supply chain digitization to mitigate geopolitical and logistical risks.

• Contract manufacturing organizations are increasingly vital in scaling API production, ensuring consistency and regulatory adherence.

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FAQs

1. What are the primary raw material suppliers for Unisom's APIs?
Major suppliers include Indian companies like Taj Pharmaceuticals and Divi's Laboratories, Chinese manufacturers such as Shanghai Pharmaceutical, and specialized European firms like Hovione, all adhering to GMP standards.

2. How do regulatory standards influence API sourcing for Unisom?
Regulatory standards dictate supplier qualification processes, requiring documentation like Drug Master Files (DMFs), GMP compliance, and validated testing protocols, which directly impact supplier selection.

3. Are there regional differences in API sources for Unisom?
Yes. Asian suppliers, particularly from India and China, dominate due to cost advantages and production capacity, while European and US-based suppliers serve markets with stringent regulatory requirements.

4. How does supply chain risk management affect API sourcing strategies?
Companies diversify suppliers and regions to mitigate risks related to geopolitical issues, export restrictions, and supply disruptions. Transparent supply chains and contingency planning are vital.

5. What role do Contract Manufacturing Organizations (CMOs) play in API sourcing for Unisom?
CMOs provide scalable, high-quality API manufacturing, often custom-developed and licensed, ensuring supply continuity and compliance with international standards.

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Sources:
[1] U.S. Food and Drug Administration (FDA) database and drug master files.
[2] Industry reports on API manufacturing from ICIS and Pharmaceutical Technology.
[3] Company websites and press releases from Hovione, Taj Pharmaceuticals, Shanghai Pharmaceutical, Divi’s Laboratories.
[4] WHO Good Manufacturing Practice guidelines.