Suppliers and packagers for generic pharmaceutical drug: GLYCINE

GLYCINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	017865	NDA	Baxter Healthcare Corporation	0338-0289-47	3000 mL in 1 BAG (0338-0289-47)	1980-05-30
B Braun	GLYCINE 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	016784	NDA	B. Braun Medical Inc.	0264-7390-60	4 CONTAINER in 1 CASE (0264-7390-60) / 3000 mL in 1 CONTAINER	2013-12-04
Otsuka Icu Medcl	GLYCINE 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	018315	NDA	ICU Medical Inc.	0990-7974-08	4 POUCH in 1 CASE (0990-7974-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG	2019-07-01

Pharmaceutical Glycine Suppliers: Global Sources by Commercial and Functional Route

Last updated: April 23, 2026

Glycine is a commodity active ingredient used across pharmaceutical, food, and chemical supply chains. Supplier options split into (1) bulk chemical manufacturers that sell pharmaceutical-grade glycine and (2) distributors that add documentation and logistics for pharma customers. Below is a supplier map by sourcing route and typical documentation position in pharma procurement.

Who supplies pharmaceutical-grade glycine at scale?

Bulk manufacturers (API-like chemical supply)

These companies produce glycine and typically offer pharma-focused grades (often branded as “pharmaceutical grade,” “USP,” “BP,” or equivalent specs depending on the customer program).

Supplier	Common supply positioning	What to confirm in qualification pack
Evonik	Specialty chemical supplier; supplies amino acids used in pharma and nutrition	Grade offered (USP/BP/EP), CoA format, residual solvents, particle size, heavy metals
Nippon Soda	Chemical manufacturer with amino acid lines	Documented pharma grade, impurity profile, endotoxin approach if claimed
Merck / MilliporeSigma	Pharma and lab-grade chemical distribution with controlled documentation	Whether the product is USP/BP/EP, lot traceability, CoA and specification sheet
TCI Chemicals	High-grade specialty chemical supply and distribution	Grade equivalence (pharma compendial vs technical), documentation completeness
Alfa Aesar (Thermo Fisher)	Chemical supply with spec sheets and lot documentation	Compendial compliance, acceptable pharma use status for intended market

Procurement reality: for commodity glycine, many pharma buyers source through distributors for faster paperwork cycles (CoA, spec, country-of-origin, and change notifications) even when the underlying manufacturer is a bulk producer.

Amino-acid specialty and bulk suppliers

Supplier	Common supply positioning	Pharma-relevant qualification checkpoints
Ajinomoto	Large-scale amino acid producer	Comendial grade listing (USP/BP/EP), heavy metals limits, microbial limits if claimed
Global suppliers via China-based amino-acid producers	Mass production of amino acids	Verify GMP status of the manufacturing site, compendial grade, impurity and metal limits, audit reports

For China-based producers, the key decision variable is not “can they sell,” but whether they ship with a pharma-grade specification package acceptable to your quality system (CoA, compendial compliance evidence, and audit readiness).

Which distributors are reliable entry points for pharma procurement?

Distributors reduce supplier friction by providing consistent documentation and consolidated logistics. They are also commonly used for qualification runs before committing to direct bulk supply.

Distributor	Typical role	Documentation to validate
Thermo Fisher Scientific (incl. Alfa Aesar)	Lab and industrial chemical supply via controlled catalog	Product grade listing, CoA availability, spec sheet version control
MilliporeSigma (Merck)	Controlled chemical catalog for compendial/lab use	USP/BP/EP compliance status, analytical methods alignment
VWR / Avantor	Distribution for chemicals and reagents	Grade identity, CoA consistency, traceability
Fisher Scientific	Distribution channel	Same as above; ensure compendial label matches your spec
Pharmaceutical ingredient distributors (regional)	Procurement routing, QA documentation packaging	Confirm MoQ, release documentation cadence, and change control process

Actionable step in sourcing: for glycine, qualification normally hinges on compendial alignment (USP/BP/EP) and contaminant controls (heavy metals, loss on drying, residue on ignition, sulfate/chloride, and related impurity limits). Suppliers that consistently provide a current CoA and spec sheet for each lot reduce downstream QA rework.

What supplier “grade” terms matter in procurement?

For glycine, supplier listings vary widely. Pharma qualification usually depends on whether the product is positioned as:

• USP grade (USP monograph compliance)
• BP grade (BP monograph compliance)
• EP grade (EP monograph compliance)
• Pharmaceutical grade (marketing term that still must be tied to a compendial or internal specification)

Compendial documentation targets

Requirement	Why it matters
USP/BP/EP monograph compliance statement	Aligns internal release testing strategy
Lot-specific CoA	Confirms each lot meets your defined acceptance criteria
Impurity profile	Glycine is simple, but residues and metals drive risk
Heavy metals limits	Key for patient and regulatory acceptance
Microbial limits (if required by your use case)	Less common for internal APIs but relevant for certain pharma dosage forms and clean operations

Which suppliers show up most frequently in commercial listings for glycine?

Below is a practical shortlist drawn from catalog-style availability and established chemical distribution channels that routinely list glycine. These names appear across multiple regions and sales models (direct, distributor, and lab supply).

1. Evonik
2. Merck / MilliporeSigma
3. Thermo Fisher Scientific / Alfa Aesar
4. TCI Chemicals
5. Nippon Soda
6. Ajinomoto
7. VWR / Avantor
8. Fisher Scientific

For direct bulk procurement, the most common route is to qualify one of the large amino-acid producers and then expand supply based on performance and documentation quality.

What to screen in supplier onboarding for glycine?

Even when glycine is a commodity, onboarding criteria should be strict and standardized. Focus on items that affect final release decisions and audit outcomes:

• Grade match: ensure the catalog “pharmaceutical grade” maps to USP/BP/EP (or your internal spec).
• CoA format and method transparency: verify analytical methods and detection limits are consistent with your spec.
• Change control: confirm supplier notifies changes in manufacturing process, site, or test methods.
• Manufacturing controls: if you require GMP-level sourcing, confirm GMP status and batch release documentation.
• Traceability: ensure lot traceability and country-of-origin documentation.

How supplier strategy changes by use case

For formulation excipient use (tablets, solutions, stabilizers)

• Prioritize compendial grade alignment and impurity/metal controls.
• Distributors are often faster for early trials and qualification batches.

For industrial pharma intermediate or process use

• Prioritize documentation cadence and cost/lead time.
• Direct bulk supply can materially reduce unit cost after qualification.

For sterile or injectable contexts

• Glycine alone is rarely sterile-ready without appropriate controls.
• Supplier must provide evidence aligned to your sterility assurance requirements and microbial/spec expectations for your manufacturing regime.

Key supplier mapping by sourcing route

Sourcing route	Best-fit supplier type	Shortest procurement path
Distributor for initial qualification	Major chemical distributors and catalog suppliers	Ship with CoA and spec package quickly
Direct bulk supply after qualification	Large amino-acid producers	Negotiate pharma-grade specs and release documentation
Multi-region availability	Suppliers with global distribution footprints	Reduce lead time volatility across markets

Key Takeaways

• Pharmaceutical glycine supply is dominated by commodity amino acid producers plus catalog and pharma chemical distributors that package documentation for qualification.
• Qualification hinges on grade identity (USP/BP/EP or defined compendial equivalence), lot CoA consistency, and contaminant controls (heavy metals, related impurities).
• A practical sourcing approach is to start with distributor catalog supply for qualification and then graduate to direct bulk supply once documentation and performance are proven.

FAQs

1) Is glycine supplied as an excipient under USP/BP/EP compliance?

Yes. Many suppliers list glycine in compendial grades. Qualification depends on matching the exact USP/BP/EP monograph alignment and lot CoA.

2) Can I source glycine directly from amino-acid manufacturers or should I use distributors?

Both are viable. Distributors usually reduce qualification friction via faster paperwork and consistent lot documentation. Direct manufacturer sourcing can reduce cost after onboarding.

3) What quality attributes most affect glycine release decisions?

Typical drivers include heavy metals limits, loss on drying, residue/ignition-related tests, sulfate/chloride-related impurities, and method-aligned impurity specifications.

4) Do suppliers always provide GMP-grade glycine?

Not universally. For GMP expectations, you must confirm manufacturing-site status and the nature of batch release documentation supplied with each lot.

5) Who are the most visible supplier names in public glycine catalogs?

Evonik, Merck/MilliporeSigma, Thermo Fisher (Alfa Aesar), TCI, Nippon Soda, Ajinomoto, and major distributors such as VWR/Avantor and Fisher Scientific frequently appear in market listings.

---

References

[1] Evonik Industries. Product information and amino acids catalog pages for glycine. https://www.evonik.com/
[2] Merck. MilliporeSigma glycine product pages and specifications. https://www.sigmaaldrich.com/
[3] Thermo Fisher Scientific. Alfa Aesar glycine catalog and product specifications. https://www.thermofisher.com/
[4] TCI Chemicals. Glycine product listings and specification sheets. https://www.tcichemicals.com/
[5] Nippon Soda. Amino acid and chemical product information. https://www.nipponsoda.co.jp/
[6] Ajinomoto. Amino acid and glycine-related corporate and product information. https://www.ajinomoto.com/
[7] Avantor / VWR. Chemical distribution listings including glycine. https://www.avantorsciences.com/