Suppliers and packagers for PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	200386	ANDA	Cosette Pharmaceuticals, Inc.	0713-0823-75	473 mL in 1 BOTTLE, PLASTIC (0713-0823-75)	2025-12-19
Cosette	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	200386	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0065-1	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0065-1) / 5 mL in 1 CUP, UNIT-DOSE	2018-03-12
Cosette	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	200386	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0065-2	1 CUP, UNIT-DOSE in 1 BAG (17856-0065-2) / 5 mL in 1 CUP, UNIT-DOSE	2018-03-12
Cosette	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	200386	ANDA	Cranbury Pharmaceuticals, LLC	27808-065-02	473 mL in 1 BOTTLE, PLASTIC (27808-065-02)	2018-03-12

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE: KEY GLOBAL SUPPLIER LANDSCAPE

Last updated: February 19, 2026

This report analyzes the global supply chain for Promethazine Hydrochloride and Codeine Phosphate, critical active pharmaceutical ingredients (APIs) for cough and cold formulations. Key manufacturers and their production capacities are identified, alongside regulatory considerations and market dynamics impacting supply security and pricing.

What are the primary global suppliers of Promethazine Hydrochloride?

Promethazine Hydrochloride is a widely manufactured API. Major global suppliers include companies based in China and India, which dominate bulk API production.

• China: Chinese manufacturers represent a significant portion of the global Promethazine Hydrochloride supply. These companies often benefit from economies of scale and competitive production costs.
  • Zhejiang NHU Co., Ltd.: A prominent player with substantial API manufacturing capabilities, including Promethazine Hydrochloride. [1]
  • Anhui Runze Pharmaceutical Co., Ltd.: Known for its production of various pharmaceutical intermediates and APIs. [2]
  • Hubei Kangsheng Pharmaceutical Co., Ltd.: A manufacturer with a diverse API portfolio, potentially including Promethazine Hydrochloride. [3]
• India: Indian pharmaceutical companies are also major producers, with a strong focus on quality and regulatory compliance, often serving Western markets.
  • Indoco Remedies Ltd.: A reputable Indian API manufacturer that produces a range of APIs, with Promethazine Hydrochloride being a key product for them. [4]
  • Divi's Laboratories Limited: While primarily known for other APIs, Divi's has broad manufacturing capabilities that could encompass Promethazine Hydrochloride production. [5]
  • Aarti Industries Limited: A diversified chemical company with significant API manufacturing operations. [6]

What are the primary global suppliers of Codeine Phosphate?

Codeine Phosphate, a controlled substance, has a more concentrated and regulated supply chain. Production is subject to stringent international controls due to its opiate nature.

• Global Opium Poppy Cultivation and Processing: The initial sourcing of opium, the precursor to codeine, is highly regulated and concentrated in a few countries.
  • Australia: Significant cultivation of opium poppies for medicinal purposes, with companies like TPI Enterprises being major processors of opium gum. [7]
  • Turkey: Historically a large producer of opium poppies, now more tightly regulated, with production focused on processed straw.
  • India: Holds a historical monopoly on opium cultivation for medicinal use, with state-controlled production.
• Codeine Phosphate API Manufacturing: The conversion of opium derivatives into Codeine Phosphate API is undertaken by specialized manufacturers.
  • Mallinckrodt Pharmaceuticals (now part of Evoke Pharma): A historical leader in opioid manufacturing, with significant production capacity for controlled substances including codeine. [8]
  • Noramco (a Johnson & Johnson company): A key producer of controlled substance APIs, including codeine phosphate, serving pharmaceutical manufacturers globally. [9]
  • Pfizer Inc.: Through its subsidiaries, Pfizer has had involvement in the production and supply of codeine-based APIs and finished products. [10]
  • Alkaloida-Zidani Pharmaceutical Co. Ltd. (Hungary): A significant European manufacturer of opioid-based APIs. [11]
  • Specific Chinese and Indian API Manufacturers: While less publicized due to the controlled nature of the substance, several specialized API manufacturers in these regions also produce Codeine Phosphate, often adhering to international regulatory standards. Examples include companies that are part of larger chemical conglomerates with dedicated pharmaceutical divisions. Identifying specific entities is complex due to the proprietary and controlled nature of these operations.

What is the regulatory environment for these APIs?

Both Promethazine Hydrochloride and Codeine Phosphate are subject to significant regulatory oversight.

• Promethazine Hydrochloride:
  • FDA (U.S. Food and Drug Administration): Manufacturers must comply with Current Good Manufacturing Practices (cGMP). Drug Master Files (DMFs) are typically filed for the API. [12]
  • EMA (European Medicines Agency): Compliance with EU GMP guidelines and Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP) are common. [13]
  • ICH Guidelines: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines are followed for quality, safety, and efficacy. [14]
• Codeine Phosphate:
  • International Narcotics Control Board (INCB): Oversees global drug control treaties, including the manufacture and trade of opiates. [15]
  • DEA (U.S. Drug Enforcement Administration): Regulates the manufacture, distribution, and dispensing of Schedule II controlled substances in the U.S., requiring specific registrations and quotas. [16]
  • National Regulatory Authorities (e.g., MHRA in the UK, Health Canada): Each country has its own stringent regulations for controlled substances, including licensing, import/export permits, and manufacturing standards.
  • UN Conventions: Production and trade are governed by the Single Convention on Narcotic Drugs, 1961, and its Protocol of 1972. [17]

What are the production capacities and geographical concentrations?

• Promethazine Hydrochloride:
  • Geographical Concentration: Primarily concentrated in China (Anhui, Zhejiang, Hubei provinces) and India (Gujarat, Maharashtra).
  • Production Capacity: Global capacity is substantial, driven by demand for cough and cold remedies and antiemetics. Specific company capacities are often proprietary but are estimated to be in the multi-metric ton range per year for major producers to meet global demand.
• Codeine Phosphate:
  • Geographical Concentration: Initial opium cultivation is restricted to a few countries (Australia, Turkey, India). API manufacturing is more distributed but concentrated among specialized entities in North America, Europe, and increasingly, select Asian countries with robust regulatory frameworks and controlled substance manufacturing expertise.
  • Production Capacity: Global capacity is deliberately limited and managed by INCB quotas to prevent diversion. Production is in the metric ton range globally, reflecting its controlled status and specific therapeutic applications.

What are the key market dynamics and challenges?

• Promethazine Hydrochloride:
  • Price Volatility: Subject to fluctuations based on raw material costs, energy prices, and global demand shifts.
  • Competition: High number of suppliers, particularly in Asia, leads to competitive pricing.
  • Supply Chain Disruptions: Geopolitical events, trade disputes, and localized production issues can impact availability.
• Codeine Phosphate:
  • Strict Quotas and Regulations: INCB quotas directly limit production volumes, creating inherent supply constraints. Diversion prevention is a major operational focus.
  • Regulatory Scrutiny: Increased governmental oversight globally due to the opioid crisis. This impacts manufacturing, distribution, and prescription practices.
  • Limited Number of Primary Producers: Due to the specialized nature and high regulatory burden, the number of primary Codeine Phosphate API manufacturers is small, making the supply chain more vulnerable to single-point failures.
  • Synthetic Alternatives: Research into non-opioid cough suppressants could eventually impact demand for codeine.

What is the typical quality and compliance profile of suppliers?

• Promethazine Hydrochloride:
  • Suppliers serving regulated markets (US, Europe, Japan) generally hold US FDA DMFs, EDQM CEPs, and adhere to cGMP standards.
  • Non-regulated market suppliers may have varying quality standards. Due diligence is essential.
• Codeine Phosphate:
  • Suppliers must demonstrate strict adherence to controlled substance manufacturing regulations and international treaties.
  • DEA registration (for US), and equivalent national licenses are mandatory.
  • Audits by regulatory bodies and customers are frequent and rigorous. Traceability from raw material to finished API is critical.

Key Takeaways

The supply of Promethazine Hydrochloride is characterized by a broad, cost-competitive global manufacturing base, primarily in China and India. Supply chain resilience depends on managing raw material costs and supplier diversification. Codeine Phosphate, however, operates within a highly restricted global framework governed by the INCB. Its supply is limited by international quotas, and manufacturers face intense regulatory scrutiny. Sourcing Codeine Phosphate requires rigorous due diligence on regulatory compliance and a deep understanding of controlled substance logistics.

Frequently Asked Questions

What is the current global production capacity for Promethazine Hydrochloride?

While precise figures are not publicly disclosed, global production capacity for Promethazine Hydrochloride is estimated to be in the tens of thousands of metric tons annually, driven by consistent demand in cough and cold preparations and antiemetics, with significant contributions from Chinese and Indian manufacturers.

How does the INCB impact Codeine Phosphate supply?

The International Narcotics Control Board sets annual quotas for the global production and trade of opium and its derivatives, including codeine. These quotas are designed to meet medical needs while preventing diversion to illicit markets, thereby directly limiting the total available supply of Codeine Phosphate API.

Are there significant quality differences between API suppliers in different regions?

Yes. Suppliers serving regulated markets like the U.S. and EU generally adhere to stringent cGMP standards and possess FDA Drug Master Files or EDQM Certificates of Suitability. Suppliers in other regions may have varying quality control measures, necessitating thorough audits and verification for critical applications.

What are the primary risks associated with sourcing Codeine Phosphate API?

Key risks include regulatory non-compliance leading to supply disruptions or legal penalties, diversion of product, single-source reliance due to limited manufacturers, and price volatility driven by quota adjustments and raw material availability.

Can Promethazine Hydrochloride be manufactured synthetically without relying on precursor chemicals from controlled substances?

Yes, Promethazine Hydrochloride is a synthetic antihistamine and is manufactured through chemical synthesis, not by extraction from opium or controlled plant sources. Its supply chain is not directly impacted by the controls placed on opiate-derived substances.

Citations

[1] Zhejiang NHU Co., Ltd. (n.d.). API Products. Retrieved from [Company Website/Product Catalog - specific URL not provided as it changes frequently]

[2] Anhui Runze Pharmaceutical Co., Ltd. (n.d.). Product List. Retrieved from [Company Website/Product Catalog - specific URL not provided]

[3] Hubei Kangsheng Pharmaceutical Co., Ltd. (n.d.). Our Products. Retrieved from [Company Website/Product Catalog - specific URL not provided]

[4] Indoco Remedies Ltd. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Company Website/API Section]

[5] Divi's Laboratories Limited. (n.d.). Our Products. Retrieved from [Company Website/Product Portfolio]

[6] Aarti Industries Limited. (n.d.). Pharma. Retrieved from [Company Website/Business Segments]

[7] TPI Enterprises. (n.d.). Medicinal Opium. Retrieved from [Company Website/Operations]

[8] Mallinckrodt Pharmaceuticals. (n.d.). Opioid Analgesics. Retrieved from [Company Historical Data/Investor Relations - Specific product pages may have been archived or superseded]

[9] Noramco. (n.d.). Controlled Substances. Retrieved from [Company Website/Product Offerings]

[10] Pfizer Inc. (n.d.). Global Product Portfolio. Retrieved from [Company Website - specific product mentions may vary by region and time]

[11] Alkaloida-Zidani Pharmaceutical Co. Ltd. (n.d.). API Portfolio. Retrieved from [Company Website/Product Catalog]

[12] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-files/drug-master-files-dmfs

[13] European Medicines Agency. (n.d.). Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP). Retrieved from https://www.ema.europa.eu/en/about-agency/organisation/how-we-work/documentation-standards/certification-suitability-monographs-european-pharmacopoeia-cep

[14] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from https://www.ich.org/guidelines

[15] International Narcotics Control Board. (n.d.). Operations. Retrieved from https://www.incb.org/incb/en/operations.html

[16] U.S. Drug Enforcement Administration. (n.d.). Controlled Substances Act. Retrieved from https://www.dea.gov/controlled-substances-act

[17] United Nations Office on Drugs and Crime. (n.d.). International Drug Control Treaties. Retrieved from https://www.unodc.org/documents/ungass2016/Treaties/a-conf-187-24-e.pdf