CYKLOKAPRON: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	CYKLOKAPRON	tranexamic acid	INJECTABLE;INJECTION	019281	NDA	Pfizer Laboratories Div Pfizer Inc	0013-1114-15	1 AMPULE in 1 CARTON (0013-1114-15) / 10 mL in 1 AMPULE (0013-1114-01)	1986-12-30
Pfizer	CYKLOKAPRON	tranexamic acid	INJECTABLE;INJECTION	019281	NDA	Pfizer Laboratories Div Pfizer Inc	0013-1114-21	10 VIAL in 1 BOX (0013-1114-21) / 10 mL in 1 VIAL (0013-1114-20)	1986-12-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

CYKLOKAPRON Suppliers: Who Manufactures and Supplies Tranexamic Acid in the US and EU?

Executive summary: CYKLOKAPRON is a brand of tranexamic acid. Suppliers are the companies holding manufacturing authorization and/or supplying API and finished dosage into the target market. The supplier landscape depends on (1) whether the market uses brand supply or generic/authorized substitutes, and (2) the dosage form (commonly IV injection and oral solid forms depending on market). This page maps the supplier categories (API makers, contract manufacturers, and finished-goods distributors) and the regulatory touchpoints (FDA Orange Book, EMA/Member State authorizations, and market authorization holders) used to identify actual upstream companies.

What companies supply CYKLOKAPRON (tranexamic acid) finished product?

Direct suppliers of CYKLOKAPRON finished product are determined by the market authorization holder (MAH) and the labeler/manufacturer of record for each strength and dosage form in each jurisdiction.

US: how to identify the actual finished-product supplier

Use FDA labeling (NDC-linked) to determine:
- Applicant/Holder (the labeler on the product listing)
- Manufacturer (the site(s) producing finished dosage form)
Use the FDA Orange Book entry status to confirm:
- Listed active ingredient(s)
- Dosage forms tied to the listing
- Patent and exclusivity linkages that can affect availability

EU/UK: how to identify the actual finished-product supplier

Identify the MAH listed on:
- EMA public registers (if centralized) or
- national competent authority databases (for decentralized/MRPs)
Use product information and manufacturing authorization listings to identify:
- Site(s) for finished product release
- Local distributors supporting supply into pharmacies/hospitals

Who supplies tranexamic acid API used to make CYKLOKAPRON?

CYKLOKAPRON’s upstream “supplier” is typically the tranexamic acid API manufacturer. API sourcing matters for supply continuity, cost, and quality system risk.

API supply chain components

API manufacturer (synthesizes tranexamic acid)
Salt/formulation interface (if applicable by specific product form)
Finished dosage contract manufacturer (lyophilization/filling, sterilization, tablet compression, coating)
Quality release and distribution into the market

How API suppliers are validated in practice

Match API manufacturer sites via:
- EU GMP certificates / inspection records
- Drug master file (DMF) holder references in regulatory submissions
- Finished-product manufacturer quality statements in product dossiers
For investors and litigators, the highest-value sources are:
- GMP inspection outcomes
- site-specific manufacturing authorizations

Which contract manufacturers typically fill and finish IV tranexamic acid like CYKLOKAPRON?

For IV products, the operational supplier list is driven by sterile manufacturing capability and container closure system supply.

IV sterile manufacturing steps that constrain suppliers

Aseptic processing or terminal sterilization (depends on formulation)
Sterile filtration (if used)
Filling and packaging (vials, prefilled syringes)
Labeling, secondary cartons, hospital packs

What to check to determine the real site supplier

The manufacturing facility listed in regulatory labeling and product dossiers
The GMP site named in EU/National authorizations
Packaging configuration tied to NDC/market presentation

What distributors supply CYKLOKAPRON to hospitals and pharmacies?

Finished-product distribution often splits into:

Wholesalers that move inventory to providers
Hospital procurement networks that contract with wholesalers or wholesalers’ preferred brands

Common distribution roles

Manufacturer/importer to national distributor
Distributor to wholesaler
Wholesaler to pharmacy/hospital system

Where to confirm distributor networks

Supply chain depends on country procurement and wholesaler contracts. Confirm through:
- NDC/labeler-linked distribution listings
- tender awards and hospital formulary entries
- local wholesaler catalogs tied to the NDC and presentation

Is CYKLOKAPRON supplied as a branded product only, or do authorized generics/alternatives dominate?

CYKLOKAPRON’s presence in a market is often influenced by:

generic tranexamic acid availability (IV and oral)
biosafety/sterility and distribution constraints
procurement preferences in hospital formularies

Why this changes “supplier” lists

When generics are available, supply shifts to:

additional finished-goods manufacturers
additional wholesalers
alternative API sources

What Orange Book status impacts CYKLOKAPRON supply in the US?

Orange Book listings can affect:

likelihood of generic entry
exclusivity timelines
product continuity risk (especially around patent events)

What to use to audit supply risk

Orange Book listing for the relevant dosage form
Patent codes and exclusivity grants tied to that listing
Any withdrawals or discontinuations that appear in FDA labeling

What patent or exclusivity events can change CYKLOKAPRON sourcing?

Even without a generic “supplier” replacing the brand, patent/exclusivity pressure can:

reallocate procurement among authorized products
influence contract manufacturing capacity planning
change who can import/supply equivalent formulations

Commercial impact categories

Increased generic substitution at hospital level
Pricing pressure that shifts purchase orders to lower-cost suppliers
Reallocation of supply among multiple brands or presentations

How does CYKLOKAPRON supplier coverage differ by dosage form and strength?

Supplier structure is presentation-specific:

IV injection vs oral solid can use different sterile/tableting lines
Strength-specific filling lines and container systems can restrict interchangeable supply

Operational implication

A supplier that can provide one presentation may not provide:

all NDC strengths
all pack sizes
both hospital and retail bundles

Which jurisdictions matter for CYKLOKAPRON sourcing: US, EU5, UK, and MENA?

Supplier lists vary materially by region because regulatory and distribution structures differ.

Region-by-region pattern

US: labeler/manufacturer of record from FDA labeling and Orange Book
EU: MAH and site authorizations across member states
UK: MHRA listings for MAH and manufacturing authorization
Other regions: often importer/affiliate distribution plus local GMP release roles

CYKLOKAPRON vs generic tranexamic acid: does the supplier base converge?

Answer: It depends on whether the generic uses the same API and/or finished-goods site.

Convergence scenarios

Shared API vendor and shared contract sterile manufacturer across brand and generic
Same MAH contract manufacturing footprint with relabeled product
Separate API and separate finish sites for different presentations

Divergence scenarios

Different API sources to manage capacity
Different sterilization/filling lines by dosage strength
Different packaging presentations tailored to procurement requirements

Key supplier map template for due diligence (what procurement and IP teams actually compile)

Use this structure to build a supplier master list per market:

Product presentation	Market	MAH/Labeler	Finished site(s)	API source	Distributor/Wholesaler	Evidence source
e.g., IV injection (strength)	US	Labeler on NDC	Sterile fill/finish site	Tranexamic acid API vendor	Wholesaler and hospital network	FDA label, Orange Book, GMP/inspection records
e.g., oral tablet/solution	EU	MAH	Manufacturing site	API vendor	National distributor	EU product info, national database, GMP

Key Takeaways

CYKLOKAPRON sourcing is best treated as three layers: API supplier, finished-product manufacturer (fill/finish or formulation site), and market distributor/wholesaler.
The fastest path to a defensible supplier list is regulatory-first: FDA labeling and Orange Book for the US; MAH and manufacturing authorization sites for EU/UK.
Supplier coverage is presentation-specific (IV vs oral, strength, packaging), so supplier lists must be built per SKU, not per brand name.

FAQs

How do I identify the manufacturer site behind a specific CYKLOKAPRON NDC?
Can the same tranexamic acid API supplier support multiple CYKLOKAPRON presentations?
Where can I confirm sterile manufacturing sites for IV tranexamic acid products?
Do hospital procurement formularies change which wholesalers supply CYKLOKAPRON?
How do Orange Book exclusivity and patent status influence generic entry timing for tranexamic acid products?

References (APA)

U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
U.S. Food and Drug Administration. Drug Label Information for approved products (NDC-linked labeling).
European Medicines Agency (EMA). Public assessment and product information registers (as applicable by authorization type).
MHRA. Medicines and manufacturing authorization records (UK).

Suppliers and packagers for CYKLOKAPRON

CYKLOKAPRON