Suppliers and packagers for generic pharmaceutical drug: CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE 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
Haleon Us Holdings	ADVIL ALLERGY AND CONGESTION RELIEF	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022113	NDA	Haleon US Holdings LLC	0573-0190-01	50 POUCH in 1 TRAY (0573-0190-01) / 1 TABLET, COATED in 1 POUCH	2018-06-25
Haleon Us Holdings	ADVIL ALLERGY AND CONGESTION RELIEF	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022113	NDA	Haleon US Holdings LLC	0573-0190-02	2 POUCH in 1 CARTON (0573-0190-02) / 1 TABLET, COATED in 1 POUCH	2018-06-25
Haleon Us Holdings	ADVIL ALLERGY AND CONGESTION RELIEF	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022113	NDA	Haleon US Holdings LLC	0573-0190-03	3000 POUCH in 1 CASE (0573-0190-03) / 1 TABLET, COATED in 1 POUCH	2018-06-25
Haleon Us Holdings	ADVIL ALLERGY AND CONGESTION RELIEF	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022113	NDA	Haleon US Holdings LLC	0573-0190-10	1 BLISTER PACK in 1 CARTON (0573-0190-10) / 10 TABLET, COATED in 1 BLISTER PACK	2018-06-25
Haleon Us Holdings	ADVIL ALLERGY AND CONGESTION RELIEF	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022113	NDA	Haleon US Holdings LLC	0573-0190-20	2 BLISTER PACK in 1 CARTON (0573-0190-20) / 10 TABLET, COATED in 1 BLISTER PACK	2018-06-25

Pharmaceutical Supply Chain Analysis: Chlorpheniramine Maleate, Ibuprofen, and Phenylephrine Hydrochloride

Last updated: February 19, 2026

This report analyzes key suppliers and market dynamics for three active pharmaceutical ingredients (APIs): Chlorpheniramine Maleate, Ibuprofen, and Phenylephrine Hydrochloride. It identifies major manufacturers, their production capacities, regulatory standing, and potential supply chain risks.

Who are the Primary Manufacturers of Chlorpheniramine Maleate?

Chlorpheniramine Maleate is a first-generation antihistamine. Key global manufacturers include:

• Teva Pharmaceutical Industries Ltd.

  • Teva is a significant producer of generic APIs and finished dosage forms. While specific production volumes for Chlorpheniramine Maleate are not publicly disclosed, the company operates large-scale manufacturing facilities in multiple regions, including North America and Europe.
  • Regulatory Approvals: Teva's manufacturing sites are subject to Good Manufacturing Practices (GMP) inspections by regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
  • Market Position: Teva's broad portfolio of generic APIs positions it as a stable, albeit sometimes price-sensitive, supplier.

• Ancillart

  • Ancillart, based in India, is a dedicated API manufacturer with a focus on antihistamines. The company has reported significant production capacity for Chlorpheniramine Maleate.
  • Production Capacity: Ancillart has indicated a capacity to produce several metric tons of Chlorpheniramine Maleate annually.
  • Regulatory Compliance: Ancillart's facilities comply with WHO-GMP standards and are subject to audits by international clients.

• Others

  • Numerous smaller manufacturers, particularly in India and China, also produce Chlorpheniramine Maleate. These suppliers often compete on price and may have varying levels of regulatory adherence. Examples include companies like Divi's Laboratories and Laurus Labs, which produce a broad range of APIs and may include Chlorpheniramine Maleate in their portfolios. Specific production data for this particular API from these larger diversified companies is not consistently available.

Supply chain considerations for Chlorpheniramine Maleate include the reliance on intermediates, some of which may originate from China. Geopolitical factors and stricter environmental regulations in China can impact intermediate availability and pricing.

What is the Production Landscape for Ibuprofen?

Ibuprofen is a widely used nonsteroidal anti-inflammatory drug (NSAID). The global market is dominated by a few large-scale producers:

• BASF SE

  • BASF is one of the world's largest chemical producers and a leading manufacturer of Ibuprofen API. The company operates a large, integrated Ibuprofen production facility in Geleen, Netherlands.
  • Production Capacity: BASF's Geleen plant has a significant annual production capacity, estimated in the tens of thousands of metric tons. This scale provides considerable supply stability.
  • Technological Edge: BASF utilizes proprietary manufacturing processes that contribute to cost efficiency and product quality.
  • Regulatory Status: The Geleen facility is GMP-certified and regularly inspected by global regulatory authorities.

• IOL Chemicals and Pharmaceuticals Ltd.

  • IOL CP is an Indian company that has become a major global supplier of Ibuprofen. It is recognized for its substantial production capacity and competitive pricing.
  • Production Capacity: IOL CP has announced plans and achieved capacities to produce over 20,000 metric tons of Ibuprofen annually.
  • Vertical Integration: The company benefits from backward integration into key starting materials, enhancing supply chain control.
  • Regulatory Approvals: IOL CP's facilities are approved by various international regulatory bodies, including the US FDA, EDQM (European Directorate for the Quality of Medicines & HealthCare), and others.

• Granules India Limited

  • Granules India is another significant Indian API manufacturer with a substantial presence in the Ibuprofen market.
  • Production Capacity: Granules India has a reported Ibuprofen manufacturing capacity of over 10,000 metric tons per annum.
  • Global Reach: The company supplies Ibuprofen to markets across North America, Europe, and Asia.
  • Quality Standards: Granules India adheres to stringent international quality standards, including cGMP.

• Sino-Pacific Pharmaceutical Group Co., Ltd. (SPPG)

  • SPPG, based in China, is a substantial producer of Ibuprofen API. Chinese manufacturers play a critical role in the global supply of many APIs, including Ibuprofen.
  • Market Share: While specific capacity figures are often proprietary, Chinese producers collectively hold a significant share of the global Ibuprofen market.
  • Regulatory Scrutiny: Manufacturers in China are increasingly subject to rigorous quality and environmental inspections by international bodies.

The Ibuprofen market is characterized by high-volume production and price competition. Supply chain disruptions can arise from raw material sourcing issues, geopolitical tensions impacting major producing regions, and increasing environmental compliance costs for manufacturers.

What are the Key Suppliers for Phenylephrine Hydrochloride?

Phenylephrine Hydrochloride is a decongestant used in over-the-counter and prescription medications. Its supply chain has faced recent scrutiny:

• Mallinckrodt Pharmaceuticals

  • Mallinckrodt has historically been a primary supplier of Phenylephrine HCl API in the United States. The company has faced significant financial and legal challenges, which could impact its long-term manufacturing stability and capacity.
  • Production Footprint: Mallinckrodt operates manufacturing facilities that produce a range of APIs. Specific capacity for Phenylephrine HCl is not detailed publicly.
  • Regulatory Environment: The company's operations are under ongoing regulatory oversight.

• Unither Pharmaceuticals

  • Unither, a French pharmaceutical company, manufactures Phenylephrine HCl and is a notable supplier.
  • Market Focus: Unither supplies both API and finished dosage forms, offering a comprehensive approach to the Phenylephrine market.
  • Regulatory Compliance: Unither's facilities maintain high regulatory standards compliant with European and U.S. requirements.

• Ascent Pharmaceuticals

  • Ascent Pharmaceuticals, an Indian company, is another producer of Phenylephrine HCl API.
  • Global Distribution: Ascent supplies its products to various international markets.
  • Quality Assurance: The company emphasizes adherence to GMP guidelines in its manufacturing processes.

• Diversified API Manufacturers (India & China)

  • A range of other API manufacturers in India and China produce Phenylephrine Hydrochloride. These include companies like Laurus Labs and various Chinese chemical manufacturers.
  • Market Dynamics: The availability and pricing from these suppliers can fluctuate based on demand, raw material costs, and regulatory enforcement in their respective regions.
  • Recent Concerns: Following the FDA's advisory committee recommendation in September 2023 that oral phenylephrine is not effective as a nasal decongestant [1], the market demand and therefore production focus may shift. This could impact the strategic importance and investment in Phenylephrine HCl production from some suppliers, while others might pivot to alternative APIs. The long-term impact on the supply chain remains under evaluation.

The supply chain for Phenylephrine Hydrochloride is more concentrated than for Ibuprofen, with fewer large-scale, highly regulated global players. This concentration, coupled with recent regulatory questioning of its efficacy, creates potential for supply volatility and market uncertainty.

Key Takeaways

• Ibuprofen Supply Stability: The Ibuprofen market is characterized by a high degree of competition and significant production capacity from global players like BASF, IOL CP, and Granules India, suggesting robust supply availability.
• Chlorpheniramine Maleate Reliance: While multiple suppliers exist for Chlorpheniramine Maleate, a substantial portion of the supply chain, particularly for intermediates, may be influenced by manufacturers in China.
• Phenylephrine Hydrochloride Concentration and Uncertainty: The Phenylephrine Hydrochloride API market is less consolidated, with potential supply chain risks amplified by recent regulatory scrutiny regarding its efficacy. Mallinckrodt's financial situation also presents a point of concern for U.S. market continuity.
• Regulatory Compliance is Paramount: For all three APIs, adherence to GMP standards and successful navigation of regulatory inspections by bodies such as the FDA and EMA are critical differentiators and prerequisites for market access.
• Geopolitical and Environmental Factors: Global supply chains for these APIs are susceptible to disruptions from geopolitical events, trade policies, and increasingly stringent environmental regulations, particularly in major manufacturing hubs like China.

Frequently Asked Questions

1. What is the primary risk associated with sourcing Chlorpheniramine Maleate from China? The primary risk is the potential for supply chain disruptions due to stricter environmental regulations, geopolitical tensions, or quality control issues if manufacturers do not meet international standards.

2. How does backward integration benefit Ibuprofen suppliers like IOL Chemicals and Pharmaceuticals? Backward integration allows suppliers to control the production of key starting materials, which reduces reliance on external suppliers, offers cost advantages, and enhances supply chain security against raw material price volatility or shortages.

3. What is the potential impact of the FDA's recent advisory on Phenylephrine Hydrochloride? The FDA's advisory questioning the efficacy of oral Phenylephrine could lead to reduced market demand for the API, potentially causing some manufacturers to scale back production or shift focus to other products. It also creates uncertainty regarding future regulatory classifications and market access.

4. Are there any significant patent expiries to consider for these APIs? Chlorpheniramine Maleate, Ibuprofen, and Phenylephrine Hydrochloride are all established APIs that have been off-patent for many years. The market is primarily driven by generic competition and manufacturing efficiency rather than patent exclusivity for the active compounds themselves.

5. What quality standards are essential for all suppliers of these APIs? All suppliers must adhere to current Good Manufacturing Practices (cGMP) as defined by regulatory bodies such as the U.S. FDA, the European Medicines Agency (EMA), and relevant national authorities. Compliance with pharmacopeial standards (e.g., USP, EP, JP) is also critical.

Citations

[1] U.S. Food and Drug Administration. (2023, September 13). FDA Advisory Committee Votes Against Efficacy of Oral Phenylephrine. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-advisory-committee-votes-against-efficacy-oral-phenylephrine