Who Makes Finasteride?
A lot of medications have at least two names: a generic name and a brand name. The generic name of a medication is the name of the active ingredient in the medication. The brand name is the name given to the medication by the pharmaceutical company that first developed and patented the medicine.
Generic drugs are available after the patent by the original developer has expired. The difference between a generic drug and the brand one is that the generic version may differ in characteristics such as manufacturing process, formulation, excipients, colour, taste, and packaging.
Finasteride is no different in that it has more than one name. Finasteride is available under its generic name as the active ingredient as well as being available under the brand names Propecia, Proscar (and more recently Aindeem).
What is Finasteride?
Finasteride is a Prescription Only Medication (POM) that belongs to the pharmacotherapeutic group known as dermatological. This means that only a duly qualified and registered doctor or non-medical prescriber can prescribe Finasteride. It cannot be purchased or supplied without the written instructions of a doctor or prescriber.
Finasteride is a competitive and specific inhibitor of human type II 5 α-reductase, an intracellular enzyme which metabolises testosterone into the more potent androgen, dihydrotestosterone (DHT).
It has no affinity for the androgen receptor and has no androgenic, anti-androgenic, oestrogenic, anti-oestrogenic, or progestational effects. Inhibition of this enzyme blocks the peripheral conversion of testosterone to the androgen DHT, resulting in significant decreases in serum and tissue DHT concentrations. Finasteride produces a rapid reduction in serum DHT concentration, reaching significant suppression within 24 hours of dosing.
Click HERE to View Finasteride Prices > >
What is Finasteride used for?
Finasteride, including the brand Proscar, is indicated for the treatment and control of benign prostatic hyperplasia (BPH) in male patients with an enlarged prostate to:
- cause regression of the enlarged prostate, improve urinary flow and improve the symptoms associated with BPH
- reduce the incidence of acute urinary retention and the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
Finasteride, including the brands Aindeem and Propecia, is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss at a dose of 1mg once daily.
What is the mechanism of action of Finasteride?
Hair follicles contain type II 5α-reductase. In men with male pattern hair loss, the balding scalp contains miniaturised hair follicles and increased amounts of DHT. Administration of finasteride decreases scalp and serum DHT concentrations in these men. Men with a genetic deficiency of type II 5α-reductase do not suffer from male pattern hair loss. Finasteride inhibits a process responsible for miniaturisation of the scalp hair follicles, which can lead to a reversal of the balding process.
In benign prostatic hyperplasia (BPH), enlargement of the prostate gland is dependent upon the conversion of testosterone to DHT within the prostate. ‘Proscar’ is highly effective in reducing circulating and intraprostatic DHT. Finasteride has no affinity for the androgen receptor.
In clinical studies of patients with moderate to severe symptoms of BPH, an enlarged prostate on digital rectal examination and low residual urinary volumes, ‘Proscar’ reduced the incidence of acute retention of urine from 7/100 to 3/100 over four years and the need for surgery (TURP or prostatectomy) from 10/100 to 5/100. These reductions were associated with a 2-point improvement in QUASI-AUA symptom score (range 0-34), a sustained regression in a prostate volume of approximately 20% and a sustained increase in urinary flow rate.
Who cannot take Finasteride?
Finasteride, as the generic Finasteride or the brands Aindeem, Proscar or Propecia, is not indicated for use in women or children under the age of 18 years. It is also contraindicated in patients that are allergic or hypersensitive to the active substance or to any of the excipients.
Aindeem or Propecia should not be taken by men who are taking ‘Proscar’ (or the generic finasteride 5 mg) or any other 5α-reductase inhibitor for benign prostatic hyperplasia or any other condition.
List of other ingredients (excipients) in each Finasteride tablet
Generic Finasteride
Tablet core:
- Lactose monohydrate
- Cellulose, microcrystalline (E460)
- Starch, pregelatinised (maize)
- Sodium starch glycolate (type A)
- Lauroyl macrogolglycerides
- Magnesium stearate (E572)
Film coating:
- Hypromellose (E464)
- Titanium dioxide (E 171)
- Macrogol 6000
- Iron oxide red (E172)
- Iron oxide yellow (E172)
Aindeem
Tablet Core
- Lactose monohydrate
- Cellulose, microcrystalline
- Pregelatinised Starch
- Lauroyl Macrogolglycerides
- Sodium starch glycolate – Type A
- Magnesium stearate
Tablet Coating
- Hypromellose 6 cps.
- Titanium dioxide (E171)
- Iron oxide yellow E 172
- Iron oxide red E 172
- Macrogol 6000
Propecia
Tablet core:
- Lactose,
- Microcrystalline cellulose E460,
- Pregelatinised maize starch,
- Sodium starch glycollate,
- Docusate sodium,
- Magnesium stearate E572,
Coating:
- Hypromellose E464,
- Hydroxypropyl cellulose E463,
- Titanium dioxide, talc,
- Yellow iron oxide E172,
- Red iron oxide E172.
Proscar
- Cellulose, Microcrystalline (E460)
- Docusate sodium
- Lactose monohydrate
- Magnesium stearate (E572)
- Pregelatinised maize starch
- Sodium starch glycollate Type A
- Yellow iron oxide (E172)
- Hydroxypropylcellulose (E463)
- Indigo carmine aluminium lake (E132)
- Hypromellose (E464)
- Talc
- Titanium dioxide (E171)
Who makes Finasteride?
Any company that manufactures medicinal products is known as a pharmaceutical company. A pharmaceutical company, sometimes known as a drug company, is a commercial business licensed to research, develop, market and/or distribute drugs, most commonly in the context of healthcare. They can deal in generic and/or brand medications. They are subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs, particularly prescription drugs.
Generic Finasteride
Since the branded versions of Finasteride came off patent, there have been several manufacturers of generic Finasteride. These include:
- Accord Healthcare Ltd
- Generics UK T/A Mylan
- Aurobindo Pharma – Milpharm Ltd
- Accord-UK Ltd
- Dr Reddy’s Laboratories (UK) Ltd
Aindeem
Accord- UK Ltd
Propecia
Merck Sharp & Dohme Limited
Proscar
Merck Sharp & Dohme Limited
Who sells Finasteride?
A Marketing Authorisation Holder (MAH) is any company, firm or non-profit organisation that has been granted a marketing authorisation.
The marketing authorisation allows the holder to market and sell a specific medicinal product, in one or more European Union (EU) member states. Once a medicinal product is marketed and in use by patients, the MAH will continue to be responsible for monitoring the safety (pharmacovigilance) of the medicinal product. Any suspected adverse reactions reported with use of the medicinal product must be reported to the body which granted the marketing authorisation, in the form of a periodic safety update report (PSUR).
As a member of the EU, Finasteride needs to have a MAH for it to be marketed and sold in the UK.
Generic Finasteride
Accord Healthcare Limited
Sage House,
319, Pinner Road,
North Harrow,
Middlesex, HA1 4 HF,
United Kingdom
Generics UK T/A Mylan
Station Close
Potters Bar
Hertfordshire
EN6 1TL
United Kingdom
Aurobindo Pharma – Milpharm Ltd
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Accord-UK Ltd
Actavis Group PTC ehf
REYKJAVIKURVEGUR 76-78,
HAFNARFJORDUR,
IS-220
ICELAND
Dr Reddy’s Laboratories (UK) Ltd
6 Riverview Road,
Beverley
East Yorkshire
HU17 OLD
UK
Aindeem
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Propecia
Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK.
Proscar
Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK.
References:
- https://www.nhs.uk/conditions/medicines-information/
- https://www.medicines.org.uk/emc/search?q=finasteride
- https://www.medicines.org.uk/emc/product/6044/smpc
- https://www.medicines.org.uk/emc/product/1008/smpc
- https://www.medicines.org.uk/emc/product/3404/smpc
- https://www.medicines.org.uk/emc/product/2194/smpc
- https://bnf.nice.org.uk/drug/finasteride.html
- https://www.merck.com/product/prescription-products/home.html
- https://www.eupati.eu/glossary/marketing-authorisation-holder/
- https://www.accord-healthcare.co.uk/newsroom/actavis-uk-ireland-are-now-accord-healthcare-0
- https://www.sciencedaily.com/terms/pharmaceutical_company.htm
Mens Pharmacy is not liable for the currency or accuracy of the information contained in this blog post. For specific information about your personal medical condition, please contact our doctors or pharmacists for advice on [email protected].