Suppliers and packagers for generic pharmaceutical drug: betaine

betaine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eton	BETAINE	betaine	FOR SOLUTION;ORAL	210508	ANDA	Eton Pharmaceuticals, Inc.	71863-115-18	180 g in 1 BOTTLE (71863-115-18)	2022-01-28
Novitium Pharma	BETAINE	betaine	FOR SOLUTION;ORAL	214864	ANDA	Cosette Pharmaceuticals, Inc.	0713-0352-81	180 g in 1 BOTTLE (0713-0352-81)	2023-01-01
Recordati Rare	CYSTADANE	betaine	FOR SOLUTION;ORAL	020576	NDA	Recordati Rare Diseases	52276-400-01	180 g in 1 BOTTLE (52276-400-01)	1996-10-25

Betaine Pharmaceutical Suppliers: Who Manufactures and Supplies Betain (Trimethylglycine) for Drug Products

Last updated: May 24, 2026

Executive summary: Key commercial suppliers of pharmaceutical-grade betaine (trimethylglycine) fall into three buckets: (1) chemical manufacturers supplying bulk trimethylglycine for pharma, (2) specialty nutraceutical/active ingredient distributors that repackage into pharma supply grades, and (3) custom manufacturers producing betaine-based intermediates or formulated dosage ingredients under contract. The most relevant sources for drug development and commercialization are the firms that (a) publish consistent product specifications for “USP/NF” or pharmaceutical-grade betaine and (b) maintain current regulatory-facing quality systems supporting API distribution.

Who supplies pharmaceutical-grade betaine (trimethylglycine)

Short answer: Betain (trimethylglycine) is supplied by bulk API chemical manufacturers and pharma ingredient distributors. The supplier landscape is concentrated in companies with established trimethylglycine production and quality documentation aligned to pharmaceutical use.

Common supplier categories

• API producers: Manufacture trimethylglycine/betaine in bulk, often positioned for “pharma grade” and export to branded manufacturers.
• Specialty distributors and importers: Provide betaine in pharma-labeled grades, batch COAs, and regulatory paperwork, sometimes with repackaging.
• Contract manufacturers: Provide betaine as an input for formulations (tablets/capsules/sachets), or for process development and GMP manufacturing of betaine-containing products.

What buyers typically require

• Pharmacopoeial alignment: “USP/NF” or equivalent grade statements tied to specifications and COAs.
• Quality documentation: GMP or DMF-linked documentation where applicable, plus batch traceability.
• Impurity profile: Controls for trimethylamine-related impurities, N-oxide species, and residual solvents per grade.

Which companies produce trimethylglycine (betaine) API for pharma

Short answer: Trimethylglycine API is produced by a limited set of established global chemical manufacturers, with distribution into pharma supply chains.

Manufacturing base countries that dominate supply

• China and India: Large-scale chemical manufacturing ecosystems with export pipelines for amino-acid and methylated intermediates.
• Europe: Smaller numbers of firms with pharma-facing quality systems.
• North America: Distributor-driven supply for many buyers, with some domestic packaging/relabeling.

Supplier short list (commercially active API supply)

The betaine market commonly includes suppliers such as:

• VWR/Avantor (pharma-grade chemical distribution via catalog supply channels)
• Sigma-Aldrich (Merck) (analytical and chemical supply channels; pharma use depends on grade and documentation)
• TCI Chemicals (chemical supply and grade-dependent distribution)
• Fisher Scientific (Thermo Fisher) (distribution for reagent/chemical grades; pharma use depends on traceability/grade)
• Zhejiang NHU / regional Chinese API producers (where they sell trimethylglycine under pharma grade specifications)
• Established amino-acid/chemical manufacturers in China that offer trimethylglycine/betaine for pharma and industrial markets

Important procurement note: Betaine is sold across multiple grades (technical, feed, food, reagent). Only a subset of catalog suppliers support pharmaceutical-grade documentation required for drug development and GMP manufacture.

Are there pharma suppliers that provide USP/NF betaine

Short answer: Some global catalog suppliers and distributors market betaine as USP/NF grade, but pharmaceutical qualification depends on whether the specific batch is supplied under the requested grade with COA/spec compliance and traceability.

How suppliers typically substantiate USP/NF or pharma-grade status

• USP/NF specification statements in the product sheet tied to a defined grade.
• Batch COAs with test results against USP/NF criteria.
• Quality agreements covering impurity limits and reporting thresholds.

What documentation do pharmaceutical betaine suppliers provide

Short answer: Pharma buyers expect COAs, impurity profiles, and quality system documentation suitable for GMP audits and batch release.

Typical documentation set

• Certificate of Analysis (COA) per lot
• Specification sheet for the purchased grade
• GMP statement or quality system summary appropriate to the purchase agreement
• DMF/CEP references where available for the relevant API grade
• Stability and shelf-life statement tied to storage conditions

How do beta in suppliers handle GMP/API supply chains

Short answer: In many cases, betaine supply is treated as an API or drug input under GMP. The supplier’s ability to support audits and documentation drives vendor approval.

Key vendor qualification checks

• Incoming Quality Control: identity testing (HPLC/assay), impurity screening, moisture or particle attributes if relevant
• Supplier audit: QMS alignment, corrective action systems, change control
• Regulatory traceability: batch numbering and batch manufacturing records linkage

Which contract manufacturers formulate betaine into finished drug products

Short answer: Contract development and manufacturing organizations (CDMOs) commonly take API inputs (including betaine) and supply tablets, capsules, granules, sachets, or oral powders. The supplier role is often separated from the API source.

Common finished forms for betaine products

• Oral tablets and capsules
• Oral powders/granules (often for higher-dose regimens)
• Sachets
• Pharmaceutical solutions (less common, depending on the product)

How to structure procurement for CDMO routes

• Route A: Buy betaine API from an API supplier and provide it to the CDMO under a supply agreement
• Route B: Ask the CDMO to source the API (with preferred vendor lists), shifting qualification burden to the CDMO

What supplier risks matter for betaine

Short answer: The primary commercial risks are grade mismatch, documentation gaps for pharma use, and batch-to-batch impurity variability if the supplier serves multiple markets.

Risk controls

• Only procure the pharma grade defined in a purchase spec
• Require COA conformity for every lot
• Audit and document impurity ranges for the purchased grade
• Change control: require notice for sourcing or process changes

How does betaine supply compare across major supplier types

Short answer: API manufacturers tend to offer the strongest documentation for raw material specs; distributors can be easier to source quickly; CDMOs control finished-product GMP but depend on approved API supply.

Comparison table: supplier type vs buyer value

Supplier type	Examples (by role)	Best for	Typical buyer need
Bulk API manufacturer	Chemical producers of trimethylglycine/betaine	Direct API procurement at scale	Supplier audit, COA/specs, impurity control
Pharma distributor	Catalog chemical suppliers, importer-distributors	Faster procurement and easier onboarding	Confirm pharma-grade documentation per lot
CDMO	Firms manufacturing tablets/capsules using betaine	Finished drug product	API approval route, QMS, regulatory support for product

Key takeaways

• Betaine (trimethylglycine) pharmaceutical supply is typically achieved through bulk API producers and pharma-grade chemical distributors; CDMOs often source betaine as an input when they run finished-product manufacturing.
• The differentiator is not “who sells betaine” but “who supplies betaine in the requested pharma grade with GMP-ready documentation, lot traceability, and impurity controls.”
• Procurement should be structured around grade-specific COAs, specification compliance, and vendor qualification (audit and change control).

FAQs

1. What’s the difference between betaine technical grade and pharmaceutical-grade betaine for drug products?
2. Can I use betaine from a lab chemical supplier in GMP drug manufacturing?
3. What impurities are typically controlled in pharmaceutical betaine (trimethylglycine) specifications?
4. Do CDMOs require a specific betaine supplier or can they approve multiple vendors?
5. How do I qualify a new betaine API supplier for a clinical or commercial batch?

References

1. USP–NF. United States Pharmacopeia and National Formulary (betaines/trimethylglycine specifications where applicable). USP.
2. Merck Millipore / Sigma-Aldrich. Product and specification documentation for trimethylglycine (grade-dependent). Merck.
3. Thermo Fisher Scientific. Product documentation for trimethylglycine/betaine (grade-dependent). Thermo Fisher Scientific.