Last Updated: May 11, 2026

Suppliers and packagers for generic pharmaceutical drug: CYSTEINE HYDROCHLORIDE


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CYSTEINE 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
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660 NDA Exela Pharma Sciences, LLC 51754-1007-1 10 mL in 1 VIAL (51754-1007-1) 2019-05-28
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660 NDA Exela Pharma Sciences, LLC 51754-1007-3 100 mL in 1 CARTON (51754-1007-3) 2019-05-28
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660 NDA Exela Pharma Sciences, LLC 51754-1008-1 1 VIAL in 1 CARTON (51754-1008-1) / 50 mL in 1 VIAL 2023-12-12
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660 NDA Exela Pharma Sciences, LLC 51754-1008-4 25 VIAL in 1 CARTON (51754-1008-4) / 50 mL in 1 VIAL 2023-12-12
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Cysteine Hydrochloride (API and Reagent-Grade)

Last updated: April 23, 2026

Who supplies L-cysteine hydrochloride and what catalog positioning do they offer?

Cysteine hydrochloride is sold broadly under two practical supply lanes: (1) pharmaceutical/API-grade L-cysteine hydrochloride and (2) food, cosmetic, and research-grade commodity chemical. Public supplier catalogs and listings often use overlapping product names such as “L-cysteine hydrochloride,” “L-cysteine hydrochloride monohydrate,” and “L-cysteine hydrochloride” without consistently stating pharmaceutical-quality status on the landing page. Below are major supplier organizations that commercially distribute or manufacture cysteine hydrochloride, grouped by typical market positioning.

Commercial suppliers (multi-grade distribution and/or manufacturing)

Supplier Common product naming seen in commerce Typical positioning in market What to verify for pharma use
Merck (MilliporeSigma) L-Cysteine hydrochloride (often multiple hydrates) Research/reagent and industrial chemical distribution Traceability to pharmacopeia grade, CoA/CoC availability, impurity profile consistency
TCI Chemicals L-Cysteine hydrochloride (hydrated variants listed by catalog) Research-grade and chemical distribution Pharmacopeia grade documentation and required impurity limits
Cangzhou-type Chinese chemical manufacturers (multiple companies commonly list L-cysteine hydrochloride) L-cysteine hydrochloride / monohydrate API-adjacent manufacturing footprint; varies by site GMP status per site, DMF/CEP availability if needed, batch-to-batch specification control
Biosynth / distributors in specialty chemicals L-Cysteine hydrochloride Specialty chemical distribution Grade designation and audit trail (GMP vs research)
Indian generics and chemical suppliers (regional distributors) L-Cysteine hydrochloride Distribution and often custom supply GMP certification and pharmacopeia/USP compliance claims

Which listings commonly cover the pharmaceutical/API-grade demand?

For API and pharma manufacturing, suppliers typically advertise one or more of the following signals: GMP manufacturing site, pharmacopeia-grade compliance (USP/EP), DMF/CEP availability, and controlled impurity specifications (heavy metals, residual solvents, specific degradants). Public catalogs often show only the reagent grade. The practical pharma-grade signal is the presence of GMP documentation and pharmacopeia alignment in the supplier’s documentation package (CoA plus formal grade designation).

What “pharmaceutical suitability” usually hinges on

Supply requirement Pharma-grade expectation
GMP manufacturing GMP-certified facility and batch production under controlled conditions
Pharmacopeia alignment USP or EP monograph grade, or internal pharma specification aligned to a compendial method
Impurity control Low heavy metals, controlled related substances, defined water/hydrate spec
Documentation CoA with full lab results, CoC when required, traceability lot data

How hydrate form changes the supply specification

Cysteine hydrochloride is commonly supplied as different hydrate forms, and pharma procurement must lock the form in the purchase specs.

Typical forms referenced in supplier catalogs

  • L-cysteine hydrochloride
  • L-cysteine hydrochloride monohydrate

Procurement impact

  • Assay and water content vary by hydrate.
  • Molecular weight differs, so dosing and conversion to cysteine equivalents must be handled explicitly.

Which global distributors and industrial chemical channels routinely carry cysteine hydrochloride?

Because cysteine hydrochloride is a high-volume chemical, global distributors often carry it and can provide lead-time and documentation support. The recurring channel pattern is:

  • Large life science distributors (Merck/MilliporeSigma, TCI) for research and industrial reagent grades
  • Specialty chemical distributors for specialty-grade offerings
  • Chemical manufacturing companies that sell via direct procurement or through regional chemical trading channels

What due-diligence checklist drives supplier selection for drug manufacturing?

For cysteine hydrochloride used in pharma contexts (manufacturing aid, formulation component, or API-related processes), supplier selection should be driven by documentation and specification fit, not only the name.

Minimum supplier checks

  1. Grade designation: explicitly states the grade tied to USP/EP or internal pharma spec.
  2. GMP statement tied to site: manufacturing under GMP at the claimed facility.
  3. CoA scope: includes assay, water/hydrate, specific impurities/related substances where applicable, and heavy metals.
  4. Change control: documented approach for specification updates, sourcing changes, and process changes.
  5. Regulatory support: whether the supplier provides DMF/CEP or relevant regulatory letters for pharma registration use (where applicable).

Supplier short list (based on public, widely stocked distribution)

This list reflects organizations that are consistently present in global commerce for L-cysteine hydrochloride and commonly provide formal CoA documents.

  • Merck (MilliporeSigma): large catalog availability, multiple hydrate listings, established documentation infrastructure.
  • TCI Chemicals: broad chemical catalog coverage, multiple hydrate references, routine CoA availability.

For GMP/API-grade procurement, the final decision must be made by matching the requested hydrate form, specification, and site GMP status to the supplier’s actual documentation package for each lot.

Key Takeaways

  • Cysteine hydrochloride is widely distributed; the critical differentiator for pharma use is grade designation, GMP site status, and controlled impurity specification, not just the product name.
  • Confirm the exact hydrate form (L-cysteine hydrochloride vs L-cysteine hydrochloride monohydrate) because assay and dosing equivalents change.
  • Reputable large distributors (notably Merck/MilliporeSigma and TCI) typically cover multiple forms and provide formal documentation; pharma/API-grade needs must be validated against GMP and compendial or internal pharma specifications for the specific supplier and site.

FAQs

1) Is cysteine hydrochloride sold as an API or as a reagent by most suppliers?

Most general catalog suppliers sell it as a chemical reagent/industrial chemical; pharma-grade use requires verification of GMP site manufacturing and pharmacopeia or pharma specification alignment in the supplier documentation package.

2) Does the hydrate form matter for pharmaceutical procurement?

Yes. Monohydrate vs non-hydrate changes water content and molecular weight, affecting assay conversion and dosing specifications.

3) Which supplier types best support pharma-grade documentation?

Large global distributors and specialty chemical suppliers that provide detailed CoA/CoC are practical starting points, but pharma qualification depends on whether they source from GMP-manufacturing sites and offer compliant grade specifications.

4) What should a CoA include for pharma-relevant purchasing of cysteine hydrochloride?

At minimum: assay, hydrate/water specification, impurities or related substances (as defined by the grade), and heavy metals. The exact list depends on the agreed specification.

5) Can the same supplier list multiple grades for the same product name?

Yes. Supplier catalogs often show multiple product grades and hydrate variants under similar names, so the purchase order must state the exact grade and form.


References

[1] Merck. L-Cysteine hydrochloride product listings and specifications. Merck MilliporeSigma website.
[2] TCI Chemicals. L-Cysteine hydrochloride product listings and specifications. TCI Chemicals website.

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