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

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Evofem Inc	PHEXX	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	PHEXX	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	PHEXX	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: June 2, 2026

Citric Acid, Lactic Acid, and Potassium Bitartrate Suppliers for Pharmaceutical Use: Who Supplies These Excipient/Ingredient Chemicals?

Executive summary: Major global suppliers for citric acid, lactic acid, and potassium bitartrate used in pharmaceutical formulations and manufacturing include large chemical producers, specialty fermentation/biotech firms, and pharmaceutical-grade excipient distributors. The supplier universe is dominated by companies that produce at scale and certify USP/NF, EP, FCC, and food/pharma grade materials, with additional documentation for GMP/DMF/QC packages depending on region and customer requirements.

Which companies supply pharmaceutical-grade citric acid (USP/EP)

Citric acid is widely used in pharma as an acidulant, buffer component, chelating agent, and effervescence component, often requiring USP/NF or EP compliance and impurity specifications (heavy metals, residual solvents, sulfated ash).

What are the main citric acid supplier profiles

Bulk chemical producers with pharma/food grades
Sell citric acid monohydrate and anhydrous forms; provide typical pharmacopeial compliance and regulatory documentation.
Regional distributors and excipient marketers
Offer repackaging, batch traceability, and local warehousing, with customer-facing documentation support.
Contract producers for specific specs
Provide controlled ash, residual solvents, and microbiological limits aligned to oral liquids, effervescent tablets, and sterile/near-sterile manufacturing needs.

Key citric acid suppliers (global)

Cargill (citric acid production and supply footprint in multiple markets)
Tate & Lyle (via specialty chemicals and supply relationships tied to fermentation-derived acids)
Prakash Industries (citric acid and related organic acids; major supplier presence)
Corbion (biobased and fermentation-derived ingredients; sells citric acid into food/pharma channels)
Zhejiang NHU Company (organic acids and related excipients supply in Asia)
Jungbunzlauer (specialty chemicals; citric acid and related actives/excipients in some portfolios)

Which companies supply pharmaceutical-grade lactic acid (USP/EP)

Lactic acid is used as an acidifier, preservative-adjacent ingredient, pH modifier, and precursor in formulations. The pharma version commonly requires defined isomer content (often L-lactic acid), limits on color, odor, residual metals, and water/impurities.

What is the production source that matters for buyers

Fermentation-derived lactic acid (L-lactic acid)
Common for pharma supply due to consistent stereochemistry and impurity control.
Purified synthetic lactic acid
Used in some non-sterile applications, with supplier-dependent spec alignment.

Key lactic acid suppliers (global)

Corbion (major global fermentation-derived lactic acid supply)
Galactic (Danisco-era brand portfolio; lactic acid through fermentation supply relationships in multiple regions)
Musashino Chemical Laboratory (lactic acid and related fermentation chemicals presence in pharma-adjacent markets)
Futaste / Zhejiang NHU Company (organic acids supply with regional pharma-grade offerings)
Evonik does not typically lead in lactic acid as a primary excipient supplier, but may appear in customer portfolios via distributors depending on grade and region

Which companies supply pharmaceutical-grade potassium bitartrate (USP/EP)

Potassium bitartrate is used in pharmaceutical and dietary formulations including effervescent systems and as a salt-forming or buffering component. Buyers often require defined water content, purity, and compliance with pharmacopeial standards and trace metals/ash specifications.

What specifications drive potassium bitartrate vendor selection

Potassium bitartrate assay and impurities (tartrate profile, sulfate, chloride, heavy metals)
Solubility and particle properties (relevant for solid oral dosage uniformity)
Batch-to-batch consistency for granulation and effervescence performance

Key potassium bitartrate suppliers (global)

Hangzhou Chemlab and similar Chinese inorganic/food-pharma ingredient manufacturers (often supply potassium bitartrate to excipient channels)
K+S group-affiliated or regional tartrate producers (market presence varies by grade)
Merck KGaA typically supplies many salts through distributors, but potassium bitartrate may be sourced rather than produced in-house depending on region
Standard excipient distributors often place potassium bitartrate from specialty chemical makers into pharma documentation formats (CoA, specifications, GMP statements)

What certifications and documentation do pharmaceutical ingredient buyers require

For excipient/ingredient procurement, buyers typically request:

USP/NF and/or EP monograph compliance
CoA and full impurity profile
DMF-linked support where applicable (more common for active APIs than excipients, but may be requested)
GMP manufacturing evidence (facility statement, ISO certification, quality agreements)
Stability documentation for formulated intermediates when relevant
Regulatory pack (TSE/BSE, allergen statements, traceability, residual solvents where relevant)

Procurement shortcut: Most suppliers can sell pharma grade, but only a subset consistently supports the full documentation set across multiple geographies and dosage forms.

How do citric acid, lactic acid, and potassium bitartrate suppliers differ by geography and regulatory pathway

United States

Common route is to buy USP/NF aligned excipients and document compliance via CoA + specifications.
Distributors often provide faster access to local inventory and US-specific documentation packages.

European Union

Buyers often require EP compliance and documentation consistent with EU quality norms.
Tighter documentation practices for impurity profiles and traceability.

Asia

Broad supplier base with scale advantages.
Buyers commonly increase incoming QC and require tailored documentation to match pharmacopeial limits.

What procurement risks exist when switching suppliers

Impurity profile drift (sulfated ash, heavy metals, specific organics, residual solvents)
Stereochemistry variance for lactic acid (L- vs DL vs isomer mixture)
Particle size and crystallinity for potassium bitartrate affecting effervescence and dissolution
Supply continuity (single-source fermentation capacity constraints for lactic acid and citric acid)
Documentation mismatch (CoA-only supply without full traceability or GMP statement)

Supplier landscape summary table (ingredient by ingredient)

Ingredient	Typical pharma role	Global supplier categories	Representative suppliers (examples)
Citric acid	Acidulant, buffer, chelator	Bulk chemical producers; fermentation-derived suppliers; pharma distributors	Cargill; Corbion; Jungbunzlauer; Prakash Industries; Zhejiang NHU; Tate & Lyle (portfolio-dependent)
Lactic acid	pH modifier, acidulant; precursor in manufacturing	Fermentation-derived lactic acid producers; specialty fermentation firms; distributors	Corbion; Galactic; Musashino Chemical Laboratory; Zhejiang NHU; other regional fermentation suppliers
Potassium bitartrate	Salt/buffering component; effervescence-related use	Tartrate specialty producers; inorganic salt makers; pharma excipient distributors	Specialty salt makers and excipient distributors; region-dependent manufacturers

Key Takeaways

Citric acid sourcing is typically dominated by large fermentation-derived and specialty chemical producers plus excipient distributors that package and certify USP/EP grades.
Lactic acid procurement is supply-chain sensitive due to stereochemistry control and fermentation capacity, with Corbion and fermentation-focused firms commonly leading.
Potassium bitartrate is more niche than citric or lactic acid, so supplier selection relies more on purity, ash/trace metals, particle properties, and documentation, often through specialty chemical manufacturers and pharma distributors.

FAQs

1) Which suppliers offer citric acid monohydrate vs anhydrous for pharma batches?
Large fermentation-derived suppliers usually cover both forms; distributors confirm the form and grade on the CoA and spec sheet.

2) What is the main sourcing constraint for pharmaceutical lactic acid?
Control of isomer form and impurity profile plus consistent fermentation-derived quality documentation.

3) Can excipient distributors supply USP/EP-compliant potassium bitartrate with GMP statements?
Yes in many cases, but the underlying manufacturer and the documentation package quality vary by distributor and lot.

4) How do I compare citric acid suppliers on regulatory readiness?
Use USP/EP compliance statements, impurity specification tables, CoA templates, traceability, and facility GMP documentation.

5) What switching-change approvals typically trigger supplier qualification for these excipients?
Changes to spec limits, impurity profile, manufacturing site, crystal form (citric acid), stereochemistry (lactic acid), and particle properties (potassium bitartrate) typically drive qualification and stability rechecks.

References

No sources were provided in the prompt, and no reliable, citable supplier list with documentation/monograph verification can be produced without external references.

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