Not Quite What It Seems

Galenisys Newsletter : July 2026

Table of Contents

• TALES FROM FARAWAY PHARMA
  Dreams on the Orinoco
  By Steve Biddulph

• LA CREME DE LA CREME
  Creams for Wrinkles, Ageing, & Sun Protection - It's that time of year again.
  By The Editor

• HOMEWARD BOUND
  Choppers, Leaders. & bugs.
  The Editor

• SHADY OUTFITS RIDE THE GLP-1 WAVE!
  FDA drug alerts: “Consumers beware”
  The Editor

TALES FROM FARAWAY PHARMA

by Steve Biddulph

Fellow of Royal Society of Biology. Board level pharma experience. QSM and Aseptic Manufacturing & Control Expertise. Galenisys Managing Director.

DREAMS ON THE ORINOCO
Where to build a factory

Our Business Director in Venezuela, imported all of the active ingredients from the mother ship in Europe and manufactured the final packed products using CMOs mainly in the capital, Caracas.

Since he was pressed for making his annual profits; he thought that local manufacturing in a new manufacturing site wholly owned by us was the way forward and, as luck would have it, a local business man was looking to offload his pharmaceutical manufacturing site. The Business Director requested Due Diligence, from QA & Industrialisation so off we went, to the local HQ in Caracas.

At our first meeting there, we learned that there was no charge for the site being acquired but that the local work force had to remain. “The site manufactured, liquids, ointments and creams and solid dose products. All were packaged there and shipped to local markets”.

“Where was the site?” we asked. “South of Caracas”, the businessman replied. Now the Orinoco and Amazon are jungle areas both south of Caracas! So, to get there meant using a plane of a local company “”Aeropostale”. (Aeropostale was a French company, established in Venezuela in 1929 by Marcel Bouilloux-Lafont and eventually taken over by the Venezuelan administration. Operations finally ceased in 2017). The flight took us south to a town where we were met by a fleet of Black SUVs and taken to the factory just outside the town.

This factory was a series of bare concrete rooms with a large hall in which people working at long trestle tables were hand packing cough syrup. There was no equipment anywhere in the building nor any other activity. We asked about the manufacture of “the liquids and solid dose products, creams and ointments” and were told that these were in the business plan for the future.

“Where does the water come from”, we asked. “We have a well and it is pumped into the factory”. There was, of course, no water purification installed on the site. “How about electricity?” - “It’s by generators!". And we surmised that as there are no roads from Caracas, fuel & everything else has to be flown in, and products flown out, not that there were any products.

We kept our thoughts to ourselves, and were soon whisked away from the factory to the local businessman’s ranch for lunch. The ranch had thousands of acres mainly dedicated to beef cattle. There were some kind of crocodiles in the rivers, and lunch was held on a terrace, which had a huge wasps nest hanging above me with the largest wasps that I have ever seen constantly flying over my head. “They are not aggressive”, our host assured me.
We were in the last savannah region before the tropical jungle, and the rivers on the ranch fed into the Orinoco.

In the best fairy stories the pharma factory would miraculously come into being “Bolivar” style against all the odds, and the loyal workforce live happily ever after. However, in the practical world we live in the acquisition of the remote “Concrete Shell” with a well, was obviously not viable proposition.
But our due diligence exercise was justified as well as providing a fascinating experience & vivid memories.

Due Diligence - a key area of Galenisys expertise - call us

LA CREME DE LA CREME

Creams for Wrinkles, Ageing, & Sun Protection. It's that time of year again.

The Editor

The right now pharmacies & supermarkets are stocked up with displays of skin creams & sun creams. Many of the products that claim (eg) “…it will make skin appear more youthful…” rely on company funded studies or consumer surveys rather than pharma standard evidence.

Some of their ingredients can reduce wrinkles & vitamins; and when applied properly can partially reverse the effects of ageing. The labels of wrinkle reducing products list molecules like retinoids, antioxidants, peptides, and exfoliating acids.

Given that the FDA etc consider creams claiming medicinal benefits fall within their remit; manufacturers need to make sure that that products meet cGMP and regulatory compliance requirements.

Remember it’s the passage of time; and environmental damage caused by UV light, pollution and smoking, which causes older looking skin.

These harm the collagen and elastin fibres so allowing wrinkles and sagging. Around 80% of ageing in white skin is caused by UV exposure (If you've got darker skin, heave a sigh of relief, you've got more melanin in it providing some degree of protection).

So firstly, there's the protection type creams: the sun creams. There's a wide range of types, and prices per ml., catering for the publics increasing awareness of the need for Sun Factor Protection against UV, (many people using SPF facial creams daily). The consumer magazines comparisons, (eg “Which” & Que Choisir”) report very high SPF label compliance, for pharmacy & supermarket products.

Then there's the “repair type creams” with a handful of their ingredients having solid scientific backing:

What’s inside?

• Biopsies and imaging show that Tretinoin a derivative of vitamin A, combats wrinkling by thickening the epidermis - the skin's outer layer – so it looks smoother). In the dermis underneath, it also stimulates collagen production to partly restore the extracellular structure.
• Whereas Tretinoin containing products are Rx only; OTC creams have got round this by incorporating milder retinoids such as Retinol and Retinal, which convert to Tretinoin after absorption. Again there's a big range of prices, & concentrations (beware Tretinoin irritation).
• Certain antioxidants eg vitamin C help collagen production, but vitamin C is unstable so correct cream formulation and storage is important.
• Some Peptides help in strengthening the extracellular matrix proteins. Others prevent their breakdown and some relax the face muscles in a manner similar to Botox.

Note that WATER !! (aka “Aqua” on the ingredients label) is the commonest ingredient in anti-ageing and sun creams. But it needs to be pure water as one of the most common reasons for a product recall is microbial contamination.

Easy to acquire and difficult to purge

It’s easy for microorganisms to get into manufacturing facilities but a lot more difficult to get rid of them from the process or finished product. These are usually opportunistic pathogens which thrive in water. Typically things like pseudomonas aeruginosa, have been found in cosmetic creams and eyedrops, burkholderia cepacia complex (Bcc), pluralibacter gergoviae, & other microorganisms that are becoming resistant to antimicrobials. All are harmful to people & have caused product recalls.

It's therefore essential that cream manufactures use the right grade of water. Galenisys have helped many companies in avoiding or getting rid of microbial contamination. We advise them how to generate and store water for injection, water for manufacture together with cGMP training and pre inspection preparation.

So, although well manufactured products with these ingredients may partly reverse the signs of ageing nothing beats the “La crème de la crème” advice, that is Protect yourself against the sun.
Tony Dunford

HOMEWARD BOUND

Choppers, Leaders. & bugs

The Editor

There were up to 14 of them down on the plain below the chalet plus others in the air for surveillance & security, but now on the morning I write, they’re homeward bound to their bases throughout France.

I guess the red and yellow ones were precautionary air ambulances, but I think certain leaders were more likely to trip up on factual matters, than on the manicured lawns of the Hotel Royal Evian.

The choppers had been here for well over a week now, and it was unusual to have the peace of the valley disturbed by their “thrum thrum thrum” every few minutes.

Last night President Macron, Prime Minister Starmer plus other members of the G7 including a Mr Trump; and Mr Modi and Gulf leaders were also dispersing to their various abodes, around the globe.

I suppose all species have a home or regular haunts so there was really no need for the Hantavirus (which we mentioned in last month's issue) to migrate from Argentina on the cruise liner because it was here in France already, where there's around 100 cases a year.

It has its home predominantly in the northeast of France amongst rodents particularly voles, (beware genuine moleskin trousers?), which live in remote locations & places rarely visited by humans such as sheds cabins and lofts.
However, the European Hantavirus is a different variant to the Andes one which the homebound tourists were unnecessarily transporting back to Europe. “Our” European one fortunately has lower lethality - less than 10%, whereas is the Andes variant achieves greater than 50% in certain circumstances.
Coming soon Ebolavirus?

Whereas the Andes hantavirus can also transmit from human to human the European variant is only transmitted by inhalation of dust contaminated by rodent saliva or droppings. So, the risk in France is judged to be low.
Whatever the transmission mechanism is, we find again the impact of global human movement on the spread of animal viruses.

It seems many species are happy to have more than one home.
Tony Dunford

SHADY OUTFITS RIDE THE GLP-1 WAVE!

FDA drug alerts: “Consumers beware”

The Editor

Such is the success of the licenced GLP - 1 drugs for weight loss and obesity, and the publicity surrounding this success, that it has attracted online merchandisers and compounders offering substandard products.

Consumers in general and Gen Z youngsters in particular are turning to the Internet for online advice on health and then purchasing products there.
The FDA recently published detailed warnings of the various dangers that consumers risk by acquiring “knockoff products”.

Counterfeit Ozempic has been marketed in the U.S. Counterfeit drugs could contain the wrong (possibly dangerous) API; or too little, too much or none of the correct one.

Unapproved versions of these drugs (including semaglutide and tirzepatide) pushed by compounders & telehealth platforms can be risky for patients, since they do not undergo FDA’s review for safety, effectiveness and quality before marketing.

So be warned off when online by these red flags:
• claims such as the compounded drug is the same as an FDA-approved drug
• medicine offered at deep discounts or too good to be true prices
• receiving different to genuine, or damaged packs to usual, or those advertised, or packs lacking instruction leaflets.
• “Does not require a screening and prescription by a licensed doctor” or similar claims.
• No licensed doctor available to answer questions after you receive your medication
• Spelling errors on the label or incorrect addresses of the pharmacy
• A pharmacy name on the label that might be fraudulent.

The agency has already warned:
• Telehealth companies for marketing unapproved drugs such as retatrutide, including instances of direct marketing to consumers.
• API distributors for selling retatrutide and other GLP-1 drugs to compounders.
• Outsourced facilities for repackaging retatrutide.
• That injectable GLP-1 drugs require specific cold temperatures during shipment & storage but certain compounded GLP-1 drugs have arrived warm or with inadequate ice packs; which can affect the drug’s quality.

AVOID COMPOUNDED VERSIONS OF THESE DRUGS
Compounded drugs are not FDA approved & the agency does not review them for safety, effectiveness or quality before they are marketed. Retatrutide and cagrilintide cannot be used in compounding under federal law. They are not components of FDA-approved drugs and have not been found safe and effective for any condition.

False labelling and dosing faults

Fraudulent compounded GLP-1 drugs semaglutide and tirzepatide have been marketed in the U.S. that contain false product label information, such as referencing non-existent compounding pharmacies, or referencing a genuine licensed pharmacy that did not compound the products. Companies have illegally sold unapproved drugs containing semaglutide, tirzepatide or retatrutide that are falsely labelled “for research purposes” or “not for human consumption.” But these products have been sold directly to consumers for human use with dosing instructions.

Adverse event reports, some requiring hospitalization, are numerous, & associated with compounded injectable semaglutide products because of incorrect dosing by pharmacy, or patients measuring and self-administering heavy or incorrect doses.

As of May 31, 2026, the FDA had received:
• 990 reports of adverse events associated with compounded semaglutide.
• more than 730 reports of adverse events associated with compounded tirzepatide.

These Adverse events related to compounded versions of semaglutide and tirzepatide are likely underreported as state-licensed pharmacies are not required to submit adverse events to FDA.

Similar names but different molecules:
Compounders have sold semaglutide salts such as semaglutide sodium and semaglutide acetate which are different molecules to the approved API, & there is no information supporting the safe use or action of these salts.

Fraudsters operate internationally online & on the above mentioned dangers are likely to be encountered in Europe and elsewhere.

Tony Dunford