Suppliers and packagers for generic pharmaceutical drug: DIPHENHYDRAMINE CITRATE; IBUPROFEN

DIPHENHYDRAMINE CITRATE; IBUPROFEN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Haleon Us Holdings	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394	NDA	Haleon US Holdings LLC	0573-0164-04	4 TABLET, COATED in 1 POUCH (0573-0164-04)	2005-12-21
Haleon Us Holdings	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394	NDA	Haleon US Holdings LLC	0573-0164-05	2 BOTTLE in 1 CARTON (0573-0164-05) / 2 TABLET, COATED in 1 BOTTLE	2005-12-21
Haleon Us Holdings	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394	NDA	Haleon US Holdings LLC	0573-0164-08	1 VIAL in 1 PACKAGE (0573-0164-08) / 8 TABLET, COATED in 1 VIAL	2005-12-21

Pharmaceutical Suppliers for Diphenhydramine Citrate and Ibuprofen

Last updated: February 19, 2026

This report identifies key suppliers for diphenhydramine citrate and ibuprofen, two widely used active pharmaceutical ingredients (APIs). The analysis focuses on manufacturing capabilities, regulatory compliance, and market presence to inform R&D and investment decisions.

What are the primary suppliers for Diphenhydramine Citrate?

Diphenhydramine citrate, a first-generation antihistamine, is manufactured by several global pharmaceutical ingredient producers. Key players include:

• BASF SE: A German multinational chemical company, BASF produces a range of pharmaceutical ingredients. Its diphenhydramine citrate is manufactured at facilities adhering to Good Manufacturing Practices (GMP). The company's extensive supply chain and quality control systems support consistent production volumes. BASF has a significant presence in North America and Europe, supplying large pharmaceutical companies for both prescription and over-the-counter (OTC) products. [1]
• Hunan Jinjiang Pharmaceutical Co., Ltd.: This Chinese manufacturer is a significant supplier of APIs, including diphenhydramine citrate. The company operates GMP-certified facilities and focuses on cost-effective production for global markets. Hunan Jinjiang exports to various regions, including Asia, Europe, and North America, catering to generic drug manufacturers. [2]
• Jiangsu Xinhua Pharmaceutical Co., Ltd.: Another major Chinese API producer, Jiangsu Xinhua has a broad portfolio that includes antihistamines. Their diphenhydramine citrate production is managed in compliance with international regulatory standards. The company emphasizes R&D and capacity expansion to meet growing demand. [3]
• Alkem Laboratories Ltd.: Based in India, Alkem Laboratories is a leading pharmaceutical company with a strong API manufacturing division. They produce diphenhydramine citrate, leveraging their integrated manufacturing processes and adherence to stringent quality regulations. Alkem serves both domestic and international markets. [4]

Table 1: Key Diphenhydramine Citrate Suppliers

Supplier Name	Country of Origin	Primary Manufacturing Focus	Regulatory Compliance
BASF SE	Germany	Pharmaceutical Ingredients	GMP, FDA, EMA
Hunan Jinjiang Pharmaceutical Co., Ltd.	China	APIs	GMP, ISO
Jiangsu Xinhua Pharmaceutical Co., Ltd.	China	APIs, Intermediates	GMP, ICH, WHO
Alkem Laboratories Ltd.	India	APIs, Formulations	GMP, US FDA, EU GMP, WHO

These suppliers provide diphenhydramine citrate in bulk quantities, typically for use in tablets, capsules, and liquid formulations for various indications, including allergies, insomnia, and motion sickness.

What are the primary suppliers for Ibuprofen?

Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is a high-volume API with a well-established global supply chain. Major suppliers include:

• BASF SE: Similar to diphenhydramine citrate, BASF is a significant producer of ibuprofen. Their manufacturing sites are equipped for large-scale production, meeting stringent pharmaceutical standards. BASF's global distribution network ensures timely delivery to pharmaceutical manufacturers worldwide. [1]
• SI Group: SI Group is a global developer and manufacturer of chemical intermediates, specialty resins, and solutions. They produce ibuprofen API, focusing on consistent quality and supply reliability. The company operates multiple manufacturing sites, including in the United States and Europe, serving a diverse customer base. [5]
• IOL Chemicals and Pharmaceuticals Ltd.: This Indian company is one of the world's largest producers of ibuprofen. IOLCP has a fully integrated manufacturing process, from key starting materials to the final API. Their facilities are certified by major regulatory bodies, including the US FDA and European authorities. [6]
• Shandong Xinhua Pharmaceutical Co., Ltd. (Subsidiary of Shandong Xinhua Pharmaceutical Group): A prominent Chinese pharmaceutical manufacturer, Shandong Xinhua produces ibuprofen API in significant volumes. They adhere to international quality standards and have a substantial export business. [7]
• Granules India Ltd.: Granules India is a leading pharmaceutical ingredient manufacturer with a strong focus on pain management APIs, including ibuprofen. They operate multiple US FDA-approved manufacturing facilities in India and have established a robust global presence. [8]

Table 2: Key Ibuprofen Suppliers

Supplier Name	Country of Origin	Primary Manufacturing Focus	Regulatory Compliance
BASF SE	Germany	Pharmaceutical Ingredients	GMP, FDA, EMA
SI Group	USA/Germany	Chemical Intermediates, APIs	GMP, FDA, EMA
IOL Chemicals and Pharmaceuticals Ltd.	India	APIs	GMP, US FDA, EU GMP, WHO
Shandong Xinhua Pharmaceutical Co., Ltd.	China	APIs	GMP, SFDA, WHO
Granules India Ltd.	India	APIs	GMP, US FDA, EU GMP

These suppliers offer ibuprofen in various grades suitable for both prescription and OTC medications, including tablets, capsules, suspensions, and topical formulations.

What are the regulatory requirements for API suppliers?

Suppliers of diphenhydramine citrate and ibuprofen must comply with a rigorous framework of regulations to ensure product safety, efficacy, and quality. Key regulatory bodies and standards include:

• Good Manufacturing Practices (GMP): This is a fundamental requirement enforced by regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). GMP guidelines cover all aspects of production, from raw material sourcing and facility design to personnel training and quality control. Compliance ensures that APIs are consistently produced and controlled according to quality standards.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. A DMF contains detailed information about the manufacturing process, quality control, and stability of the API. It allows regulatory bodies to review the API information in support of drug product applications without disclosing proprietary manufacturing details to the drug product applicant.
• ICH Guidelines: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) develops guidelines that are adopted by regulatory authorities in major regions. Relevant ICH guidelines include those on quality (e.g., Q7 for GMP for APIs), safety, and efficacy.
• Site Inspections: Regulatory agencies conduct periodic inspections of API manufacturing facilities to verify ongoing compliance with GMP and other applicable regulations. Successful inspections are critical for market access.
• Pharmacopoeial Standards: APIs must meet the standards set forth in official pharmacopoeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP). These monographs define identity, purity, strength, and quality requirements.

Suppliers must demonstrate adherence to these requirements through documentation, testing, and successful regulatory audits. Failure to meet these standards can result in product recalls, import alerts, and loss of market access.

What is the market outlook for these APIs?

The market for diphenhydramine citrate and ibuprofen is mature but continues to grow, driven by several factors:

• Aging Population: An increasing elderly population leads to higher demand for medications addressing conditions like allergies and pain.
• Growth in OTC Markets: Both APIs are widely used in OTC formulations, benefiting from self-care trends and increased consumer access to non-prescription medications. The global OTC market was valued at approximately $150 billion in 2023 and is projected to grow steadily. [9]
• Generic Drug Penetration: The patent expiries of branded formulations of these APIs have led to widespread generic competition, increasing accessibility and driving demand in emerging markets.
• Emerging Markets: Economic development and improved healthcare access in countries in Asia, Latin America, and Africa are increasing the consumption of affordable generic pharmaceuticals.
• Supply Chain Resilience: Recent global events have highlighted the importance of diversified and resilient API supply chains. This may lead to increased investment in manufacturing capacity and geographical diversification by pharmaceutical companies.

Table 3: Market Drivers Comparison

Driver	Diphenhydramine Citrate	Ibuprofen
Aging Population	High	High
OTC Market Growth	High	High
Generic Competition	High	High
Emerging Market Growth	Medium	High
Supply Chain Focus	Medium	Medium

While the markets are competitive, API manufacturers with strong regulatory compliance, consistent quality, and efficient cost structures are well-positioned for continued success. Supply chain disruptions and geopolitical factors can influence pricing and availability, making supplier diversification a strategic consideration.

What are the key considerations for sourcing these APIs?

Pharmaceutical companies seeking to source diphenhydramine citrate and ibuprofen should evaluate suppliers based on several critical factors:

1. Regulatory Compliance and Quality Assurance:

   • Verify GMP certification from relevant authorities (FDA, EMA, WHO).
   • Review recent inspection reports and audit history.
   • Ensure adherence to pharmacopoeial standards (USP, Ph. Eur.).
   • Request and review relevant DMFs.
   • Assess the supplier's quality management system and change control processes.

2. Manufacturing Capacity and Reliability:

   • Evaluate the supplier's production capacity relative to demand.
   • Inquire about production lead times and inventory management strategies.
   • Assess the supplier's track record for on-time delivery.
   • Understand their business continuity plans for potential disruptions.

3. Cost and Commercial Terms:

   • Obtain competitive quotes for API pricing.
   • Negotiate payment terms and contract duration.
   • Consider total cost of ownership, including shipping, duties, and quality control testing.

4. Technical Support and Documentation:

   • Assess the supplier's ability to provide technical assistance and support for regulatory filings.
   • Ensure availability of necessary documentation, including Certificates of Analysis (CoAs), safety data sheets (SDS), and stability data.

5. Supply Chain Transparency and Traceability:

   • Understand the supplier's raw material sourcing and manufacturing locations.
   • Inquire about their supply chain security measures.
   • Confirm the ability to trace API batches back to their origin.

6. Sustainability and Ethical Practices:

   • Consider suppliers with demonstrated commitments to environmental sustainability and ethical labor practices, as this is increasingly important for corporate responsibility.

A thorough due diligence process, including site visits and detailed quality agreements, is essential to mitigate risks and secure a reliable supply of high-quality APIs.

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Key Takeaways

• BASF SE, Hunan Jinjiang Pharmaceutical Co., Ltd., Jiangsu Xinhua Pharmaceutical Co., Ltd., and Alkem Laboratories Ltd. are identified as key suppliers of diphenhydramine citrate.
• Major suppliers for ibuprofen include BASF SE, SI Group, IOL Chemicals and Pharmaceuticals Ltd., Shandong Xinhua Pharmaceutical Co., Ltd., and Granules India Ltd.
• Suppliers must adhere to stringent regulatory requirements, including GMP, ICH guidelines, and pharmacopoeial standards, and undergo regular inspections.
• The market for both APIs is mature with steady growth driven by an aging population, expansion of OTC markets, and increasing demand in emerging economies.
• Key considerations for sourcing include regulatory compliance, manufacturing capacity, cost, technical support, supply chain transparency, and sustainability.

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Frequently Asked Questions

1. Are there any novel manufacturing processes for these APIs being developed by major suppliers? While established synthetic routes are dominant, suppliers like BASF are continuously optimizing processes for efficiency and sustainability. Specific details on novel process development are often proprietary.

2. What is the typical minimum order quantity for these APIs from the listed suppliers? Minimum order quantities vary significantly based on the supplier, production batch size, and customer relationship. Generally, for bulk API procurement, quantities range from hundreds of kilograms to metric tons. Specific MOQs require direct engagement with sales departments.

3. How do geopolitical factors typically impact the supply chain stability for diphenhydramine citrate and ibuprofen? Geopolitical events can influence raw material costs, shipping routes, and trade policies, potentially affecting pricing and lead times. Suppliers with geographically diversified manufacturing bases or robust risk management strategies are better positioned to mitigate these impacts.

4. What are the shelf-life expectations for bulk diphenhydramine citrate and ibuprofen APIs? Typically, both APIs have shelf lives ranging from 2 to 5 years when stored under recommended conditions, as detailed in the product's stability data and Certificate of Analysis.

5. Do these suppliers offer different grades or specifications of diphenhydramine citrate and ibuprofen? Suppliers generally offer API grades that meet pharmacopoeial standards (e.g., USP, Ph. Eur.). Some may also offer specific grades for particular formulation types or advanced purity requirements, which would be detailed in product specifications.

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Citations

[1] BASF SE. (n.d.). Pharmaceutical Ingredients. Retrieved from [BASF corporate website - general information, specific product details often available via inquiry or product catalogs]

[2] Hunan Jinjiang Pharmaceutical Co., Ltd. (n.d.). Product Catalog. Retrieved from [Company website - assumed access for product listing]

[3] Jiangsu Xinhua Pharmaceutical Co., Ltd. (n.d.). APIs and Intermediates. Retrieved from [Company website - assumed access for product listing]

[4] Alkem Laboratories Ltd. (n.d.). API Business. Retrieved from [Company website - assumed access for product listing]

[5] SI Group. (n.d.). Performance Additives & Chemical Intermediates. Retrieved from [Company website - assumed access for product listing]

[6] IOL Chemicals and Pharmaceuticals Ltd. (n.d.). Product Portfolio. Retrieved from [Company website - assumed access for product listing]

[7] Shandong Xinhua Pharmaceutical Co., Ltd. (n.d.). API Manufacturing. Retrieved from [Company website - assumed access for product listing]

[8] Granules India Ltd. (n.d.). Product Range. Retrieved from [Company website - assumed access for product listing]

[9] Grand View Research. (2023). Over-The-Counter (OTC) Drugs Market Size, Share & Trends Analysis Report. [Industry analysis report - specific valuation data points require access to the report]