FOLLITROPIN ALFA INJECTION bulk supplier for pharma manufacturers

Follitropin ALFA Injection 150 IU Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 150 IU

Reference Brands: Gonal-f (US/EU)

Follitropin alfa 150 IU, recombinant FSH for ovulation induction, ovarian stimulation in assisted reproduction and male hypogonadotropic hypogonadism, for importers, distributors and fertility clinic buyers.

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Product Description:

Follitropin alfa is recombinant human follicle-stimulating hormone (FSH), made in Chinese hamster ovary cells with the same amino acid sequence as natural FSH. In women it drives growth and maturation of ovarian follicles; in men it supports sperm production. The 150 IU listed here is a single-dose amount; follitropin alfa also comes as vials of powder for reconstitution and multidose pre-filled pens. It is injected under the skin, so most patients learn to self-inject at home during a stimulation cycle.

It is used in women with anovulation, including polycystic ovary syndrome, unresponsive to clomifene; for ovarian stimulation before IVF and ICSI; with lutropin alfa in severe LH and FSH deficiency; and with hCG in men with hypogonadotropic hypogonadism. Doses are individual, adjusted by ultrasound follicle tracking and oestradiol levels. The main risks are ovarian hyperstimulation syndrome and multiple pregnancy, and thromboembolism in susceptible women. Thyroid, adrenal and pituitary disease and reproductive tumours are excluded first. Fertility specialists prescribe it.

Sourcing notes. This is a biological, and biosimilar follitropin alfa products are authorised in Europe and elsewhere, so state whether you need the reference product or a biosimilar, as substitution rules vary. Store and ship at 2 to 8 °C, away from light and never frozen; some presentations allow a limited period at room temperature, as the label sets out. Ask for a CoA per batch with biological potency, the GMP certificate, a CoPP, validated shipping data and the CTD dossier. It is prescription-only. Specify IU strength, presentation, needles supplied and shelf life on arrival.

Follitropin ALFA Injection — third party manufacturing & bulk supply

Follitropin ALFA Injection 150 IU is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Follitropin ALFA Injection is supplied as Injection — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Follitropin ALFA Injection listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

FOLLITROPIN ALFA INJECTION is listed as Injection in 150 IU. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

FOLLITROPIN ALFA INJECTION is referenced against Gonal-f (US/EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.