Major Manufacturers of Generic ED Meds: CIPLA LIMITED

Being a huge pharmaceutical company with over 80 years of history, Cipla Limited proves that the market of generic ED medications is not reserved to small players that manufacture products of questionable quality. This Indian corporation with headquarters in Mumbai and offices in more than 100 countries of the world currently makes over 1,500 medications, around 250 of which have been developed internally. Cipla’s products sell in over 80 countries where they are approved by local healthcare authorities including the US FDA, UK MHRA, TGA of Australia, MCC of South Africa and many more. International sales make up 53% of Cipla’s USD 2.2B yearly revenue.

There are more than 25,000 people employed by Cipla in India and worldwide. The company is currently listed on Bombay Stock Exchange and the National Stock Exchange of India.

Cipla currently holds patents for 24 pharmaceuticals, which shows that copying other companies’ drugs is far not everything that its scientists are capable of. Its medications are used in cancer, HIV, diabetes, hepatitis and malaria therapy, as well as in urology, dermatology, ophthalmology, etc.

Curiously, Cipla’s current success is due to anti-impotence medications that the father of Cipla’s current chairman brought into India from Germany in the 1930s. The medication named Okasa was selling so well that it earned Hamied family enough money to start their own pharmaceutical manufacturing business in 1935. The company’s presence on ED treatment market remains strong although it is no longer fundamental for the company. In today’s article we will be focusing on generic ED medications that Cipla Limited manufactures and markets worldwide today. This includes both traditional PDE-5 inhibitors like sildenafil and tadalafil and products used to treat testosterone deficiency in men. We will also briefly go over other important medicines manufactured by Cipla and see how they impact the pharmaceutical market worldwide.

Sildenafil-Based ED Medications

Most of Cipla’s ED medications containing sildenafil (Cipla generic Viagra) are similar to Viagra in terms of active ingredients, effect and directions for use. The recommended starting dosage is 50mg, taken 30 minutes to an hour before the expected intercourse. Depending on the patient’s response and/or any other conditions affecting the treatment, the dosage may further be increased to 100mg or reduced to 25mg. The effect lasts for up to 6 hours. You should not take more than 1 tablet of sildenafil in 24 hours. Always consult your doctor prior to starting the treatment with sildenafil to make sure this medication is right for you.

Sildenafil – a vasodilator from the group of PDE-5 inhibitors used mainly in the treatment of erectile dysfunction and pulmonary arterial hypertension. Normally, vasodilation and, consequently, penile erection are preceded by the release of nitric oxide from the nerve endings, which triggers an increase in cyclic guanosine monophosphate (cGMP) levels. PDE-5 is an enzyme responsible for the narrowing of the blood vessels after the sexual intercourse is over. By inhibiting its release and keeping cGMP levels high, medications like sildenafil stimulate harder, more lasting erections. Sildenafil was discovered by a group of scientists from Pizer and patented in 1996.

Silagra

This version of sildenafil by Cipla is manufactured in 3 standard strengths of 25mg, 50mg and 100mg of sildenafil per tablet. The tablets are oval with a score line in the middle, light purple or blue in color depending on which country you’re purchasing them from. The packaging design also varies in different countries. Silagra 100mg costs around $0.37 in India but the prices in international online pharmacies are usually higher than that – from $0.65 to $5 a pill. Silagra (sildenafil citrate 100mg) is not approved by the FDA or EMA yet.

Suhagra

Similarly to Silagra, Suhagra is sildenafil-based and available as 25mg, 50mg and 100mg oval blue-colored tablets. The color of the packaging depends on the strength of the tablets – 25mg pills come in white-and-green packages, 50mg ones – in white-and-blue, and 100mg ones – in white-and-red. All tablets come with a score line, which is useful for those patients who only need half the dose. Suhagra costs around Rs27 or $0.37 in India and between $0.50 and $5 online. As of 2018, it is not approved by the FDA or EMA.

Cipla sildenafil

A non-branded version of sildenafil for ED treatment is available in South Africa. It comes in black packages containing 2 or 4 oval film-coated tablets, violet in color. Cipla sildenafil is approved by the MCC, which is the South African alternative of the US FDA. The only available strength is 50mg.

Cipla Limited also manufactures sildenafil (Cipla generic Viagra) under the brand name Assurans. Note that this medication is intended for treatment of pulmonary arterial hypertension, not ED, and contains only 20mg of sildenafil per tablet.

Tadalafil-Based ED Medications

Like brand-name Cialis, Cipla’s tadalafil -based medications listed below can be used for treatment of erectile dysfunction and benign prostatic hyperplasia. In the former case, the recommended starting dose Cipla pill is 10mg taken at least 30 minutes before intercourse. It may be adjusted to 5mg in case of side effects or concomitant health conditions that require a dose reduction or increased to 20mg if the desired effect was not achieved with a 10mg dose. Tadalafil works for up to 36 hours after being taken. When used to treat ED together with BPH, tadalafil is to be taken daily, 2.5mg or 5mg per day.

Tadalafil – a PDE-5 inhibitor used in the treatment of erectile dysfunction, pulmonary arterial hypertension and benign prostatic hyperplasia. Its mechanism of action is identical to that of sildenafil – what sets tadalafil apart is the prolonged duration of action resulting from its half-life of 17.5 hours (sildenafil has a half-life of only 4 hours). Tadalafil was discovered by Glaxo Wellcome pharmaceutical company in 1991.

Tadacip

Tadacip is a brand of tadalafil by Cipla that is widely available in India, Thailand and other countries as well as online. It comes in white-and-blue (10mg pills) or red (20mg pills) packaging, each package containing 4 yellow almond-shaped pills with “10” or “20” imprinted on one side depending on the strength. Tadacip costs around $0.41 per tablet in India while online pharmacies offering international shipping usually charge between $0.53 and $1.50 per tablet for it.

Erectalis FC

Erectalis FC is very similar to Tadacip – in fact, these two drugs even have the same package and tablet design. The only available strength is 20mg. According to the prices quoted on MedIndia, Erectalis FC is slightly more expensive than Tadacip, costing 32Rs or $0.44 per tablet in India.

Tadaflo

Tadaflo is the low-strength tadalafil-based oral medication manufactured by Cipla Limited and containing 5mg of tadalafil per tablet. No alternative strengths are available. Tadaflo is intended for treating concomitant erectile dysfunction and benign prostatic hyperplasia. It is taken once daily, 1 pill per day for up to 26 weeks. The tablets are round, light orange in color and offered in white-and-orange packages of 30 tablets each.

Cipla tadalafil

Unlike the three drugs listed above, the non-branded version of tadalafil by Cipla Limited has already received tentative approval from the US FDA in October 2018 and is expected to start selling soon. The design of the new medication for the US market has not been disclosed yet. Cipla tadalafil has also been licensed by the MHRA in the UK where it is available both as the daily pill (2.5mg and 5mg strengths, round pinkish yellow tablets with “T2.5” or “T5” imprint) and as the pills for use as needed (10mg and 20mg strengths, capsule-shaped yellow tablets with “T10” or “T20” imprint).

Cipla Limited also makes tadalafil for pulmonary arterial hypertension treatment under the brand name Pulmopres. Tadalafil is the only active ingredient in Pulmopres – all other ingredients are excipients meaning they do not affect the mechanism of action of tadalafil in any way and do not have any medicinal properties of their own. Therefore, Pulmopres can be safely used off-label for ED treatment.

IMPORTANT! Disregard the original directions for use on the package leaflet is you are using Pulmopres for treating ED, not PAH.

PAH is treated with 40mg of tadalafil or 2 Pulmopres tablets taken once daily.
ED is treated with 10mg to 20mg of tadalafil or 1/2 to 1 Pulmopres tablet taken 30-60 minutes before sex. A maximum daily dosage of 20mg should not be exceeded.

Using Pulmopres for treatment of concomitant ED and BPH is not recommended. These conditions require a daily dose of 2.5mg to 5mg of tadalafil. This would require splitting Pulmopres tablets into 4-8 segments, which makes obtaining an exact dose very difficult.

Alternative Medications by Cipla Limited Used for ED Treatment

Men suffering from erectile dysfunction and other disorders due to testosterone deficiency are advised to try alternative forms of treatment – such as testosterone replacement therapy, for instance. Note that testosterone replacement is not recommended in patients in whom ED is the only symptom associated with low testosterone levels. Testosterone deficiency is more likely to develop in older or overweight people, as the result of damage to the testicles, excessive physical labor or training or intake of xenoestrogenic chemicals, among other reasons.

Although testosterone deficiency is not linked to erectile dysfunction directly and some men with low testosterone do get normal erections, there are certain ways in which this condition affects sexual performance. First, low testosterone results in decreased sex drive, consequently leading to erectile dysfunction. Second, hypogonadism, a condition when a man’s testes cannot produce enough testosterone, is associated with a higher risk of cardiovascular conditions and diabetes which may also result in impotence.

Testosterone replacement therapy or TRT is a form of treatment that involves administration of exogenous testosterone by patients suffering from hypogonadism. Transdermal patches, topical gels and creams and injectable solutions are the most common dosage forms for TRT. Oral testosterone medications also exist but are rarely prescribed because of possible negative effects on the liver.

TRT is only prescribed to patients who have several of the symptoms listed below caused by low testosterone:

Low sex drive
Erection problems
Depression
Sleeping disorders
Weight problems (decreased muscle mass, increased body fat)
Low bone density
Attention disorders.

Until recently doctors tried to avoid testosterone replacement therapy whenever possible because of the adverse reactions they believed were caused by exogenous testosterone. However, a recent study by Grech et al shows that the risks associated with TRT may be overestimated. It’s proven that TRT can cause cardiovascular conditions, metabolic disease, lower sperm quality, breast tenderness and enlargement in males and also make people more aggressive. Whether or not it can cause other conditions previously associated with it is yet unclear. TRT is contraindicated in people with prostate cancer, breast cancer or recent history thereof.

Cipla Limited currently manufactures the following testosterone-based hormonal medications:

Testosterone cypionate injections – approved by the FDA in 2018, marketed outside of the US under the brand T-Him.
Testosterone capsules – sold as Androfil in India, not approved by the FDA yet.
Topical testosterone gel – sold as Androfil Gel in India, not approved by the FDA yet.

These medications are currently available for purchase in online and land-based pharmacies operating from India. T-Him costs around $9 for one 4ml vial containing 1000mg of testosterone undecoanate, which equals to approximately 630mg of pure testosterone. One Androfil capsule will cost you about $0.18 while a 5-gram tube of topical Androfil is priced at around $0.66.

Other Key Medications by Cipla Limited

The list below is not exhaustive and only lists the pharmaceuticals that are either widely used globally or make up a significant part of Cipla’s revenue.

Antiretrovirals

Cipla is currently one of the world’s leading manufacturers of HIV/AIDS medications. In 115 countries of the world, one in every three people living with HIV is taking a Cipla drug. The company also supplies its antiretroviral drugs at unprecedented low prices as part of their ‘Dollar a Day’ program that makes full-scale HIV therapy available for about $300 a year.

All in all, Cipla manufactures 16 antiretroviral medications including:

3-in-1 solutions like Trioday (Efavirenz + Lamivudine + Tenofovir disoproxil fumarate), Viraday (Efavirenz + Emtricitabine + Tenofovir disoproxil fumarate),
Pre-exposure and post-exposure prophylaxis drugs used for HIV prevention like Tenvir EM,
Drugs used to prevent mother-to-child transmission of HIV – the so-called Mother-Baby Pack.

More HIV drugs, such as an oral 4-in-1 formulation for children are in development.

Medications Used in Respiratory Disease Treatment

Cipla manufactures medications used in the treatment of various respiratory diseases ranging from allergic rhinitis and asthma to respiratory tract infections and even lung cancer. It specializes in inhalable formulations producing well over 100 million inhalers annually. Cipla’s range of products includes several world-firsts such as Tiotropium + Formoterol for chronic obstructive pulmonary disease therapy as well as world’s first generic Bosentan and sildenafil, both used for pulmonary arterial hypertension treatment.

Medications Used in Urinary Tract Disease Treatment

The list of urological conditions that can be treated with drugs manufactured by Cipla includes:

prostate cancer – Calutide and Cassotide tablets,
benign prostatic hyperplasia – Urimax tablets and capsules, Duoflo Combipack, etc.,
bladder cancer – Oncogem and Oncodox injections,
acute urinary retention – Urivoid tablets,
urinary tract infections – Fosirol powder,
bladder stones – Ston1 solution,
and more.

If you’re considering treatment with generic medications, the products by Cipla Limited would be a great choice. This Indian company’s pharmaceuticals are very cheap compared to their brand-name alternatives yet highly reliable. Unfortunately, not all of them are legally available in certain countries including the US yet but that is likely to change in the nearest future as the market of generics continues growing. In the meantime, some of Cipla’s products are readily available for purchase in online pharmacies, some of which even offer international shipping.

Sources:

Cipla Limited in numbers, annual report 2017-19 – https://www.cipla.com
Cipla Limited financial report including yearly revenue – https://in.investing.com
The history behind Cipla Limited – https://www.thehindubusinessline.com
Silagra price in India – https://www.medindia.net
Silagra prices online – http://globalrxexpress.com
Suhagra price in India – https://www.medindia.net
Suhagra prices online – https://www.canadianpharmacyworld.com
Cipla sildenafil approval status in South Africa – https://www.pharmacompass.com
Assurans product information – https://ciplamed.com
Tadacip price in India – https://www.medindia.net
Tadacip prices online – https://www.canadianpharmacyworld.com
Erectalis FC price in India – https://www.medindia.net
Tadaflo product information – https://ciplamed.com
Cipla tadalafil approval status, US FDA, ANDA 209539 – https://www.accessdata.fda.gov
Package leaflet for Cipla tadalafil tablets from MHRA UK website, license PL 36390-0220 – http://www.mhra.gov.uk
Pulmopres product information – https://ciplamed.com
Men with low testosterone levels are not recommended to start TRT if erectile dysfunction is the only symptom – http://www.choosingwisely.org
Low testosterone doesn’t directly cause ED – https://www.webmd.com
J Rajfer, Relationship between testosterone and ED, low testosterone causes decreased libido – https://www.ncbi.nlm.nih.gov
C.J. Bagatelli, W.J. Bremner, Relationship between testosterone and cardiovascular risk – https://academic.oup.com
D Westaby et al, Liver damage due to long-term use of methyltestosterone – https://www.ncbi.nlm.nih.gov
A Grech et al, Adverse erects of TRT – https://www.ncbi.nlm.nih.gov
Cipla testosterone cypionate injections FDA approval status – https://www.accessdata.fda.gov
T-Him price in India – https://www.1mg.com
Androfil capsules price in India – https://www.1mg.com
Androfil gel price in India – https://www.1mg.com
Stats on the use of antiretroviral drugs by Cipla – https://www.hivplusmag.com
Cipla’s ‘Dollar a Day’ HIV treatment program – http://blog.cipla.com
Cipla’s Tenvir EM gets approval in India – https://www.thehindubusinessline.com
Cipla develops Mother-Baby HIV prevention pack – http://blog.cipla.com
Cipla’s products for treatment of respiratory diseases – https://www.cipla.com
Calutide tablets for prostate cancer treatment – https://ciplamed.com
Cassotide tablets for prostate cancer treatment – https://ciplamed.com
Urimax capsules for BPH treatment – https://ciplamed.com
Duoflo Combipack for BPH treatment – https://ciplamed.com
Oncogem for treatment of bladder cancer and other forms of cancer – https://ciplamed.com
Oncodox for treatment of transitional cell bladder carcinoma and other forms of cancer – https://ciplamed.com
Urivoid tablets for acute urinary retention treatment – https://ciplamed.com
Fosirol powder for treatment of complicated UTIs – https://ciplamed.com
Ston1 solution for treatment of bladder stone – https://ciplamed.com

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