CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352	NDA	Evofem, Inc.	69751-100-03	3 APPLICATOR in 1 BOX (69751-100-03) / 5 g in 1 APPLICATOR (69751-100-01)	2020-08-01
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352	NDA	Evofem, Inc.	69751-100-12	12 APPLICATOR in 1 BOX (69751-100-12) / 5 g in 1 APPLICATOR (69751-100-01)	2020-08-01
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352	NDA	Evofem, Inc.	69751-101-12	12 APPLICATOR in 1 BOX (69751-101-12) / 5 g in 1 APPLICATOR (69751-101-01)	2020-08-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 4, 2025

ppliers for the Pharmaceutical Drugs: Citric Acid, Lactic Acid, Potassium Bitartrate

Introduction

The global pharmaceutical industry relies on a select group of suppliers capable of providing high-quality excipients such as citric acid, lactic acid, and potassium bitartrate. These compounds serve as key ingredients in medicines, dietary supplements, and infusion fluids, necessitating stringent quality standards and reliable supply chains. This article examines prominent suppliers of these compounds, highlighting their manufacturing capacities, compliance standards, and strategic importance to pharmaceutical companies.

Citric Acid Suppliers

Overview
Citric acid is a widely used food additive and pharmaceutical excipient, primarily serving as an pH adjuster, chelating agent, and stabilizer. The pharmaceutical grade citric acid must meet purity standards outlined by pharmacopeias such as USP, EP, and JP.

Key Suppliers

Jungbunzlauer
As a leading global manufacturer, Jungbunzlauer produces highly purified citric acid with ISO 9001 and ISO 22000 certifications. Their manufacturing plants in Austria and Canada serve the pharmaceutical industry with products meeting USP, EP, and JP standards.
Cargill
Cargill offers pharmaceutical-grade citric acid produced through fermentation processes. Their facilities in the USA, Europe, and Asia ensure broad supply capabilities and compliance with regulatory standards, including FDA and EMA approvals.
Weifang Ensign Industry Co., Ltd.
Based in China, this manufacturer supplies high-grade citric acid that complies with international pharmacopeias. They possess GMP certification, allowing them to serve global pharmaceutical clients.
Coca-Cola Co. (Specialty Chemicals Division)
While primarily known for beverages, Coca-Cola’s chemical arm supplies pharmaceutical-grade citric acid, focusing on quality and sustainability.

Supply Trends and Considerations

Increasing demand for high-purity citric acid driven by the growth of oral and injectable pharmaceuticals.
Emphasis on sustainable production, with many suppliers adopting green fermentation technologies.
Regulatory compliance remains critical, with suppliers maintaining certifications aligned with international standards.

Lactic Acid Suppliers

Overview
Lactic acid is used in pharmaceuticals as an excipient and pH regulator, with applications in injectable solutions, topical formulations, and dietary supplements. It requires pharmaceutical or food grade quality, with strict standards per USP, EP, and JP.

Top Suppliers

Henan Jindan Lactic Acid Technology Co., Ltd.
A major Chinese producer, Jindan supplies food- and pharmaceutical-grade lactic acid produced via fermentation. The company holds ISO, GMP, and other certifications to meet international standards.
Musashino Chemical Laboratory Ltd.
Based in Japan, Musashino manufactures pharmaceutical-grade lactic acid with consistent quality control aligned with USP and EP. Their production facilities are compliant with good manufacturing practices (GMP).
BASF SE
A global chemical giant, BASF produces lactic acid for pharmaceutical applications, emphasizing high purity, sustainable production processes, and compliance with regulatory norms.
Corbion
With manufacturing facilities across Europe and North America, Corbion specializes in bio-based lactic acid, emphasizing sustainability and purity certifications suitable for pharmaceutical use.

Market Dynamics

Growing interest in bio-based, non-GMO lactic acid sources to meet consumer and regulator preferences.
Suppliers investing in fermentation technology to improve yields and reduce costs.
Increasing regulatory scrutiny around microbial fermentation practices, emphasizing traceability and contamination control.

Potassium Bitartrate Suppliers

Overview
Potassium bitartrate, also known as cream of tartar, is used as an excipient, stabilizer, and in pharmaceutical formulations requiring a precise pH balance or electrolyte replenishment. It must meet quality standards per pharmacopeias such as USP and EP.

Key Suppliers

Mitsubishi Shoji Foodtech Co., Ltd.
This Japanese company supplies pharmaceutical-grade potassium bitartrate, emphasizing purity, consistent particle size, and compliance with global standards.
Yingkou Fushun International Trade Co., Ltd.
Based in China, they produce pharmaceutical-grade cream of tartar used in various formulations, with certifications including HACCP, GMP, and ISO.
K+S Group
A German-based producer of specialty chemicals, K+S offers high-purity potassium bitartrate, especially for high-end pharmaceutical applications, with stringent quality controls.
Harbin Pharmaceutical Group
They supply potassium bitartrate used in medications, adhering to international pharmacopeia standards.

Supply and Market Trends

Demand driven by formulations requiring electrolyte balance and pH control.
Emphasis on purity and particle specification to prevent contamination or variation in pharmaceutical products.
Supply chain diversification to mitigate risks posed by regional geopolitical issues affecting China and other key markets.

Regulatory and Quality Considerations

Suppliers targeting the pharmaceutical sector must adhere to Good Manufacturing Practices (GMP) and hold certifications from regulatory authorities such as the FDA (United States), EMA (Europe), and the TGA (Australia).

Additionally, suppliers must demonstrate batch-to-batch consistency, non-GMO status where required, and traceability throughout the production chain. Certifications like ISO 9001, ISO 22000, and HACCP are standard benchmarks for ensuring quality standards.

Strategic Implications for Pharmaceutical Companies

Supplier Validation: Rigorous qualification processes are essential to select suppliers with robust quality systems and compliance histories.
Supply Chain Resilience: Diversification across regions—Europe, North America, and Asia—reduces dependency on a single source or region, mitigating risks from geopolitical or environmental disruptions.
Sustainability and Bio-Based Options: Partnerships with bio-based producers such as Corbion reflect industry pivot towards environmentally sustainable excipients.
Monitoring Regulatory Compliance: Continuous monitoring of supplier certifications and adherence to evolving pharmacopeial standards ensures seamless regulatory approval and product safety.

Key Takeaways

Leading global suppliers of citric acid, lactic acid, and potassium bitartrate include Jungbunzlauer, Cargill, BASF, and Corbion, each offering high-quality, GMP-compliant products aligned with international pharmacopeias.
The industry emphasizes sustainable fermentation technologies and bio-based raw materials, aligning with broader environmental goals.
Supplier qualification must focus on regulatory compliance, traceability, and manufacturing consistency to safeguard pharmaceutical quality and supply continuity.
Diversification across geographic regions reduces dependency risks, especially for critical excipients.
Ongoing innovation and adherence to evolving standards remain vital for suppliers aiming to serve the global pharma industry effectively.

FAQs

1. What are the main quality standards suppliers must meet for pharmaceutical-grade citric acid?
Suppliers must comply with pharmacopeial standards such as USP, EP, and JP, along with certifications like GMP, ISO 9001, and ISO 22000 to ensure purity, safety, and batch consistency.

2. How does bio-based production impact lactic acid suppliers?
Bio-based production, primarily via fermentation of renewable substrates, enhances sustainability and appeals to regulatory and consumer demands for non-GMO, environmentally friendly excipients.

3. Which regions dominate the supply of potassium bitartrate?
China and Europe are primary producers, with key suppliers such as Yingkou Fushun and K+S Group. Diversifying sources across regions mitigates geopolitical and logistical risks.

4. What factors influence supplier selection for pharmaceutical excipients?
Key factors include regulatory compliance, product purity, production capacity, certification standards, sustainability practices, and supply chain resilience.

5. Are there recent innovations in excipient sourcing for pharmaceuticals?
Yes, innovations include green fermentation technologies, bio-based sourcing, and improved processing techniques that enhance purity and reduce environmental impact.

Sources

Jungbunzlauer. "Citric Acid API." [Online] Available at: https://www.jungbunzlauer.com/global/en/products/citric-acid/
Cargill. "Pharmaceutical and Food Grade Citric Acid." [Online] Available at: https://www.cargill.com/food/beverages/citric-acid
BASF SE. "Lactic Acid Bio-Based." [Online] Available at: https://www.basf.com/global/en/products/ingredients/pharma/solutions.html
Corbion. "Bio-Based Lactic Acid." [Online] Available at: https://www.corbion.com/products/lactic-acid
K+S Group. "Potassium Bitartrate Chemical Specifications." [Online] Available at: https://www.kpluss.com/en/solutions/industry-solutions/food-production/cream-of-tartar/

Suppliers and packagers for generic pharmaceutical drug: CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE