Introduction

Actiza Pharmaceutical is a WHO-GMP certified pharmaceutical exporter supplying Cyclophosphamide for Injection as a sterile finished dosage formulation not API to importers, oncology distributors and hospital tender procurement across Africa, Southeast Asia, Latin America and the Middle East.  

Vial presentations span 200 mg, 500 mg, 1 g and 2 g, manufactured in a dedicated cytotoxic sterile block under aseptic conditions with validated containment.

Cyclophosphamide is a WHO Essential Medicine and the highest-volume cytotoxic in global use, appearing in CHOP, AC, CMF and BEACOPP protocols, so continuity of supply is the buying criterion.

Complete CTD, ACTD and eCTD dossiers, CoPP, FSC and ICH Zone IVb stability data are supplied for MOH registration.

Product Overview Table

Field	Details
Product Name	Cyclophosphamide for Injection
INN / Generic Name	Cyclophosphamide (as cyclophosphamide monohydrate)
Therapeutic Class	Cytotoxic antineoplastic oxazaphosphorine nitrogen mustard alkylating agent
Mechanism (brief)	Polyfunctional alkylating agent; cross-links DNA, interfering with replication and RNA transcription. Also possesses potent immunosuppressive activity.
Prodrug Note	Requires hepatic activation; the metabolite acrolein drives urinary toxicity and underlies the use of mesna and hydration
Indications	Malignant lymphomas, Hodgkin disease, multiple myeloma, leukaemias, neuroblastoma, ovarian and breast carcinoma, retinoblastoma, mycosis fungoides  per approved local labelling
API Quality	Manufactured using DMF-grade Cyclophosphamide Monohydrate
Pharmacopoeial Standard	USP  Cyclophosphamide for Injection USP; BP / IP available
Vial Presentations	200 mg, 500 mg, 1 g, 2 g single-dose vials
Formulation Types	Lyophilised powder (with mannitol) OR non-lyophilised sterile powder (with sodium bicarbonate)  see Section 5B, this choice has regulatory consequences
Preservative	None  single-dose vial; aseptic technique required on reconstitution
Sterilisation Method	Aseptic processing  terminal sterilisation not applicable
Storage	Store at or below 25°C. Brief exposure up to 30°C is withstood; protect from above 30°C.
Cold Chain	NOT required ambient distribution, unlike Carmustine Injection
Thermal Integrity	Temperature influence during transport or storage can melt the active ingredient; melted vials are visually identifiable and must not be used see Section 5F
Shelf Life	24-36 Months
Manufacturing Facility	WHO-GMP certified DEDICATED cytotoxic sterile block
Handling	Hazardous product cytotoxic handling and disposal procedures apply
Dossier Available	Yes CTD / ACTD / eCTD format

Vial Presentations & Sterility Assurance

Cyclophosphamide for Injection 500 mg & 1 g

The two highest-volume vial sizes worldwide, because standard adult regimens dosed by body surface area draw most efficiently from this pair.

In CHOP, AC and CMF protocols the 500 mg and 1 g vials together cover the great majority of adult doses with minimal wastage, which is why tender specifications almost always request them as a set rather than individually.

Cyclophosphamide for Injection 200 mg

The low-dose vial, important for paediatric oncology and for dose adjustment in low-body-surface-area or renally compromised patients.

Where a programme treats children, the 200 mg vial materially reduces drug wastage across a treatment cycle a genuine cost argument in budget-constrained oncology services, and one worth making explicitly in tender responses.

Cyclophosphamide for Injection 2 g

The high-dose vial, used in high-dose protocols including conditioning regimens and in adult patients requiring large single doses. Reduces vial handling per dose, which matters in a cytotoxic preparation setting where every vial entry is an exposure event for the pharmacy technician.

Sterility Assurance

Aseptic processing Grade A filling under Grade B background per ISO 14644, with HEPA-filtered unidirectional airflow and routine environmental monitoring

Aseptic performance verified through periodic media fill validation, since a sterile powder in a vial has no terminal lethality step to fall back on

Sterility per USP <71>; bacterial endotoxins per USP <85> (LAL); particulate matter per USP <788> on the reconstituted solution

Water content by Karl Fischer, reconstitution time, and clarity of the reconstituted solution are practical quality attributes that hospital pharmacy notices immediately.

Container closure integrity demonstrated across shelf life for the vial and stopper system.

The product contains no antimicrobial preservative, so single-dose vial integrity and the sterility argument carry the full burden.

Regulatory & Dossier Support

Dossier Availability

CTD (Common Technical Document): ICH-aligned, for regulated and semi-regulated markets

ACTD (ASEAN Common Technical Dossier):  Philippines, Vietnam, Myanmar, Indonesia, Cambodia

eCTD for authorities mandating electronic submission

Module 3 quality documentation including aseptic process validation and media fill data, lyophilisation cycle validation where applicable, container closure qualification, residual moisture control and reconstitution characterisation.

Stability data: real-time and accelerated under ICH Zone IVb (30°C / 75% RH), with defined thermal excursion studies given the melting behaviour of the active ingredient, plus in-use stability for the reconstituted solution.

Country-specific dossier customisation and regulatory query response support included

Bioequivalence: Why Your Excipient System Decides the Registration Route

Cyclophosphamide for injection is supplied worldwide in two distinct excipient systems.

The lyophilised presentation is a sterile cake containing cyclophosphamide with mannitol the reference material describes approximately 75 mg mannitol per 100 mg cyclophosphamide.

The non-lyophilised sterile powder presentation instead contains sodium bicarbonate, at approximately 82 mg per 100 mg cyclophosphamide. These are not cosmetic differences.

Because the product is administered intravenously, bioequivalence (BE) is normally self-evident under the parenteral provisions regulators waive in vivo BE where a parenteral product contains the same active and inactive ingredients in the same concentration as the reference.

The words “and inactive” are what matter here. If the reference product registered in your target market is the mannitol-based lyophilised form and your product is the sodium-bicarbonate-based powder, Q1/Q2 sameness fails, and the biowaiver is not available.

For a cytotoxic, the fallback is an in vivo study in cancer patients, which is exactly the slow and costly route the Procarbazine page describes.

The practical consequence: the choice between lyophilised and non-lyophilised is a regulatory strategy decision, not just a manufacturing preference.

It should be made against the reference product registered in your target market, before development is locked. Ask us first, and we will tell you which form your market needs.

We can advise on the reference product basis in your target market and confirm which of our presentations preserves the biowaiver route there.

Comparative characterisation of the reconstituted solution appearance, pH, osmolality, assay, degradation profile and reconstitution time is supplied to support the waiver argument.

Drug Master File (DMF)

Drug Master File (DMF) reference for the Cyclophosphamide Monohydrate API available for cross-referencing in your registration dossier

API sourced against a qualified vendor with full impurity, degradation product, residual solvent and water content characterisation

CDSCO / Indian DMF reference accepted by a large number of importing authorities  shortens query cycles

Manufacturing Compliance

WHO-GMP certified manufacturing facility, audit-ready, with inspection reports shared on an NDA basis

Site Master File (SMF) available for regulatory submissions

Manufactured in a dedicated cytotoxic sterile block, with dedicated premises, equipment, and air handling under a controlled pressure regime, with containment and aseptic requirements resolved through cascaded airlocks

Volume capability matters on this molecule in a way it does not on niche cytotoxics: cyclophosphamide moves in tender quantities, so campaign scheduling within a contained sterile block is a capacity question buyers should ask about directly.

Water for Injection system qualified and monitored with endotoxin and conductivity trending

Cytotoxic waste and effluent management documented; operator protection controls including PPE requirements at every handling stage.

Cleaning validation against a toxicologist-authored HBEL / Permitted Daily Exposure, with analytical methods sensitive enough to demonstrate compliance

Compliant with the requirements of NAFDAC (Nigeria), PPB (Kenya), FDA Philippines and INVIMA (Colombia)

Complete Documentation Package (Per Shipment)

Document	Purpose
Certificate of Analysis (CoA)	Confirms batch quality against the agreed specification
Certificate of Pharmaceutical Product (CoPP / CPP)	Required for MOH registration in most importing countries
Free Sale Certificate (FSC)	Confirms the product is freely sold in the country of manufacture
Method of Analysis (MOA)	Analytical methodology mandatory dossier component
GMP Certificate	Confirms site compliance, including the dedicated cytotoxic sterile block
Stability Data	Real-time, accelerated, thermal excursion and in-use reconstituted stability
Sterility Test Report	USP <71> product-critical, no terminal sterilisation step in the process
Bacterial Endotoxin Report	USP <85> LAL against the calculated endotoxin limit
Media Fill Validation Summary	Aseptic process assurance the substitute for a terminal lethality value
Biowaiver Justification (Q1/Q2)	Composition comparison against the reference registered in the target market
Reconstitution Characterisation	Reconstitution time, clarity, pH and osmolality of the prepared solution
Container Closure Integrity Test (CCIT)	Vial and stopper seal integrity across shelf life
HBEL / PDE Assessment	Toxicologist-authored exposure limit underpinning cleaning acceptance criteria
Cytotoxic Handling Guidance	For destination pharmacy PPE, spillage response, waste segregation

Thermal Integrity & Vial Inspection  [PRODUCT-SPECIFIC ADDITION]

Cyclophosphamide does not require cold chain. Vials are stored at or below 25°C and will withstand brief exposure up to 30°C.

But the active ingredient can melt under sustained temperature influence during transport or storage, and reference labelling directs that vials showing signs of melting must not be used.

Melted cyclophosphamide is visually identifiable as a clear or yellowish viscous liquid, present either as a connected phase or as droplets in the affected vial.

Receipt inspection is a field check the buyer can perform. Vials should be inspected visually before use; any showing the viscous liquid described above must be rejected rather than reconstituted.

We supply the inspection guidance in the consignment documentation in the destination language, as we do for Carmustine, so the receiving pharmacy can apply it without locating the reference label.

Ambient shipping, but not indifferent shipping. Containers must not be stowed against hot bulkheads and should not stand on an exposed dock in tropical conditions.

Our stability package includes defined thermal excursion studies so that a warm-transit consignment is assessed against data rather than guessed at

Reconstituted stability is defined in reference labelling and differs by diluent and storage condition; the leaflet must carry the applicable in-use period and the instruction that the product contains no preservative.

Hazardous product handling applies from unpacking onward cytotoxic PPE, spillage response and waste segregation guidance is supplied with each consignment.

Clinical Indications & Therapeutic Information

Cyclophosphamide is a polyfunctional alkylating agent of the oxazaphosphorine class.

It cross-links DNA, interfering with replication and with transcription of RNA, and it also possesses potent immunosuppressive activity which is why the molecule appears both in oncology protocols and, in some approved labels, in immune-mediated conditions.

Cyclophosphamide is included on the WHO Model List of Essential Medicines under cytotoxic medicines, and WHO Expert Committee documentation records extension of its listed indications to diffuse large B-cell lymphoma.

This listing keeps it permanently inside national essential medicines lists and recurring oncology tenders.

Label indications span malignant lymphomas including Hodgkin disease, lymphocytic and Burkitt lymphoma; leukaemias; multiple myeloma; neuroblastoma; ovarian and breast carcinoma; retinoblastoma; and mycosis fungoides always per the approved label in the market of supply.

It is a prodrug, requiring hepatic activation. The metabolite acrolein is responsible for urinary tract toxicity, which is the basis for hydration and mesna co-administration in higher-dose protocols and a practical reason to quote mesna alongside cyclophosphamide in tender responses.

Reference labelling directs that patients report urinary symptoms including pink or red discolouration of urine, and covers myelosuppression, immunosuppression and infections that may be fatal, with routine blood cell count monitoring. These warnings must carry through to leaflet and artwork in full.

Market structure: this is the highest-volume cytotoxic in global use, appearing in CHOP, AC, CMF and BEACOPP among many others.

Unlike Carmustine or Procarbazine, it is a genuine tender commodity which means the competitive variables are quality documentation, vial-size range and supply continuity rather than scarcity.

Target Export Markets

Africa

Active markets: Nigeria, Kenya, Ethiopia, Egypt, Tanzania, Ghana, Uganda, Zambia, Zimbabwe, Côte d’Ivoire

Registration support: NAFDAC (Nigeria), PPB (Kenya), FDA Ghana, TFDA (Tanzania) CoPP and FSC are the primary gatekeeping documents

National cancer control programmes and referral cancer centres procure in tender volumes; the 200 mg vial is a differentiator where paediatric oncology services are active

Labelling: English and French artwork available for Anglophone and Francophone Africa

Southeast Asia

Active markets: Philippines, Vietnam, Myanmar, Cambodia, Indonesia, Bangladesh, Thailand

ACTD dossier format supplied as standard  mandatory for ASEAN registrations

Stability: ICH Zone IVb data plus documented thermal excursion studies are essential here, given ambient temperatures relative to the 25°C storage condition

Latin America (LATAM)

Active markets: Colombia, Peru, Ecuador, Bolivia, Guatemala, Dominican Republic

USP pharmacopoeial standard preferred; Spanish and Portuguese labelling available

CTD format with local regulatory adaptation, legalisation and apostille support

Middle East & CIS

Active markets: Iraq, Jordan, Yemen, Uzbekistan, Kazakhstan, Azerbaijan

GMP Certificate and CoPP are the primary registration requirements across these authorities

Arabic and Russian labelling available on request

Export Packaging & Supply Chain

Packaging Configuration

Component	Specification
Vial	Type I clear glass single-dose vial with bromobutyl rubber stopper and aluminium flip-off seal
Vial sizes	200 mg, 500 mg, 1 g and 2 g
Protective sleeve	Plastic vial protection sleeve available to reduce breakage and contamination risk in cytotoxic handling [TBC]
Carton	Individual carton with leaflet, cytotoxic identification and storage statement
Tender / Programme Supply	Multi-vial shipper configurations with programme overprinting [TBC]

Vial breakage is a contamination event on a cytotoxic, not merely a stock loss, which is why protective sleeving and shipper construction deserve more attention on this product than on an ordinary injectable.

Cartons carry cytotoxic identification so the product is visually distinguishable in a hospital pharmacy, and each carton is individually inspectable so vials can be checked on receipt without breaking down a full consignment.

Labelling & Customisation

Private label manufacturing with your brand name and artwork, subject to unchanged regulatory and cytotoxic content

Multi-lingual labelling: English, French, Spanish, Portuguese, Arabic, Russian

Mandatory artwork content: store at or below 25°C statement, cytotoxic identification, single-dose and no-preservative statement, reconstitution diluent instruction, in-use period, myelosuppression and urinary toxicity warnings, and country-specific registration number fields

Logistics & Supply

Incoterms: FOB, CIF, CFR, EXW as per buyer requirement

No cold chain required, but ambient does not mean unmanaged: protect from temperatures above 30°C, avoid stowage against hot bulkheads, and avoid extended dock standing in tropical ports.

Because this is a tender-volume product, we plan dedicated cytotoxic sterile block campaigns against committed annual forecasts.

Buyers bidding on multi-year oncology tenders are advised to confirm volumes at bid stage rather than at award, so capacity is reserved before the commitment is made.

Why Source Cyclophosphamide Injection From Us?

Formulation Advice That Protects Your Registration: We tell you which excipient system the reference product in your target market uses, and therefore which of our presentations preserves the parenteral biowaiver route there. Registering the wrong form costs a year.

Dedicated Cytotoxic Sterile Manufacturing: Dedicated premises, equipment and air handling, with containment and aseptic requirements resolved by design. GMP certificate and Site Master File (SMF) shared on request.

Aseptic Assurance With Data: No terminal sterilisation step exists for a sterile powder in a vial, so media fill validation, filtration validation and environmental monitoring carry the sterility argument.

We supply the package. Full Vial Range Including 200 mg: 200 mg, 500 mg, 1 g and 2 g.

The 200 mg vial reduces wastage materially in paediatric oncology, which is a real cost argument in a tender response.

Thermal Integrity Documented, Not Assumed  Defined excursion studies plus receipt-inspection guidance in the destination language, so a warm-transit consignment is assessed on evidence rather than written off.

WHO Essential Medicine, Tender-Scale Continuity: Cyclophosphamide is on the WHO Model List of Essential Medicines and moves in tender quantities.

We schedule contained sterile campaigns against committed forecasts so continuity is engineered.

Frequently Asked Questions (FAQ)