Coronavirus 2019-nCoV

[Kung Wu]

If this continues to grow in Asia and the Middle East, we can expect drug shortages. Many Active Product Ingredients and excipients are sourced from these regions. The delivery for most of these ingredients is three to six months, with delivery of the drug product being another three to six months, so stock up if you need drugs to live a normal life. Shortages will occur in the second half of 2020.

What type of drugs will we see a shortage in?

[wufan]

What type of drugs will we see a shortage in?

It certainly depends on how long this lasts and where it occurs. If it is a true pandemic, it will be most of them. Making a drug product is much like baking a cake. You need 3 to 5 ingredients. You add them together and turn on a blender. It’s then divided out into servings (dosages) and distributed to the pharmacies.

You get each of the ingredients from different places in the world. If the supply chain of any of the 3 to 5 ingredients (sometimes as many as ten) are shut off, then you can’t make the product. Let’s say that your citric acid (used as a buffer to match the pH of the human body) comes from China, and you placed an order in November for delivery in May. The order is accepted and the manufacture is planned for January. Well, it’s not manufactured until March due to Coronavirus, and it doesn’t arrive until June, so the batch planned for May doesn’t release to market until October, leaving a market shortage for two to three months.

Due to regulations, you can’t just switch to the Swedish brand of Citric Acid. It must be approved by the FDA prior to using the Swedish brand. This takes six months. Because Asian and middle eastern products are so much cheaper, much of the products come from those countries.

If you are using a drug that has multiple brands, your chances are greatly increased that it will be available without interruption. If you are using a proprietary drug, chances are that it is a complex biologic with several ingredients, and it is more likely to in shortage.

[Shocker1976]

It certainly depends on how long this lasts and where it occurs. If it is a true pandemic, it will be most of them. Making a drug product is much like baking a cake. You need 3 to 5 ingredients. You add them together and turn of a blender. It’s then divided out into servings (dosages) and distributed to the pharmacies.

You get teach of the ingredients from different places in the world. If the supply chain of any of the 3 to 5 ingredients (sometimes as many as ten) are shut off, then you can’t make the product. Let’s say that your citric acid (used as a buffer to match the pH of the human body) comes from China, and you placed an order in November for delivery in May. The order is accepted and the manufacture is planned for February. Well, it’s not manufactured until April due to Coronavirus, and it doesn’t arrive until July, so the batch planned for May doesn’t release to market until August.

Due to regulations, you can’t just switch to the Swedish brand of Citric Acid. It must be approved by the FDA prior to using the Swedish brand. This takes six months. Because Asian and middle eastern products are so much cheaper, much of the products come from those countries.

If you are using a drug that has multiple brands, your chances are greatly increased that it will be available without interruption. If you are using a proprietary drug, chances are that it is a complex biologic with several ingredients, and it is more likely to in shortage.

Interesting description wufan; may I ask if you have experience in developing and manufacturing prescription only drugs?

[wufan]

Interesting description wufan; may I ask if you have experience in developing and manufacturing prescription only drugs?

I do. At the risk of sounding arrogant, it is safe to say that at this point in my career that I am an expert in the field. I consult with the FDA and other similar foreign regulatory bodies regularly, write scientific papers, and contribute to national and international regulatory policy. My specific area of expertise is in analytical compliance and scientific data validation, but am very involved in international procurement and quality control for drug substance and drug product.

[MoValley John]

I do. At the risk of sounding arrogant, it is safe to say that at this point in my career that I am an expert in the field. I consult with the FDA and other similar foreign regulatory bodies regularly, write scientific papers, and contribute to national and international regulatory policy. My specific area of expertise is in analytical compliance and scientific data validation, but am very involved in international procurement and quality control for drug substance and drug product.

So can you score me some good lettuce?

[Kung Wu]

So can you score me some good lettuce?

Wait is that a drug, or you just want some healthy farm produce?

[Shocker1976]

I do. At the risk of sounding arrogant, it is safe to say that at this point in my career that I am an expert in the field. I consult with the FDA and other similar foreign regulatory bodies regularly, write scientific papers, and contribute to national and international regulatory policy. My specific area of expertise is in analytical compliance and scientific data validation, but am very involved in international procurement and quality control for drug substance and drug product.

You are a Regulatory Affairs consultant? Do you consult with pharmaceutical companies developing products for licensure?

I also have some experience in pharmaceuticals but more from the commercial side of the equation. During my career I had management responsibility for a wide area of drug and monoclonal antibody development and commercialization. Even had the "pleasure" of working with the Chinese Regulatory Authorities to license a reformulated API and witnessed first hand the theft of my company's manufacturing technology. The Third Chinese Army began selling the product while our application was under review. We withdrew the application and watched the Chinese knock-off fail due to quality issues (manufacturing secrets can be telling).

[wufan]

You are a Regulatory Affairs consultant? Do you consult with pharmaceutical companies developing products for licensure?

I also have some experience in pharmaceuticals but more from the commercial side of the equation. During my career I had management responsibility for a wide area of drug and monoclonal antibody development and commercialization. Even had the "pleasure" of working with the Chinese Regulatory Authorities to license a reformulated API and witnessed first hand the theft of my company's manufacturing technology. The Third Chinese Army began selling the product while our application was under review. We withdrew the application and watched the Chinese knock-off fail due to quality issues (manufacturing secrets can be telling).

I will send you a PM.

[wufan]

You are a Regulatory Affairs consultant? Do you consult with pharmaceutical companies developing products for licensure?

I also have some experience in pharmaceuticals but more from the commercial side of the equation. During my career I had management responsibility for a wide area of drug and monoclonal antibody development and commercialization. Even had the "pleasure" of working with the Chinese Regulatory Authorities to license a reformulated API and witnessed first hand the theft of my company's manufacturing technology. The Third Chinese Army began selling the product while our application was under review. We withdrew the application and watched the Chinese knock-off fail due to quality issues (manufacturing secrets can be telling).

We had an antibiotic where we started getting complaints that some of the patients were spiking fevers when administered. Turns out our Chinese API had undetectable pyrogens. We tested every bit of it that we received and never saw anything. The FDA tested it too. We had to inject it into bunnies to finally find the issue.

[Shocker1976]

We had an antibiotic where we started getting complaints that some of the patients were spiking fevers when administered. Turns out our Chinese API had undetectable pyrogens. We tested every bit of it that we received and never saw anything. The FDA tested it too. We had to inject it into bunnies to finally find the issue.

A start-up company I was with was developing a bladder installation treatment that contained an API manufactured in China. We had to suspend our program when we discovered the Chinese supplier had substituted an inexpensive filler in the manufacturing process that changed the PK profile. Patients died, the FDA withdrew its approval of the manufacturer and I was told the Chinese Communists shot the plant manager. I don't know if this action by the Chicoms is true but I do think it was possible.

[SB Shock]

First domestic death of the coronavirus. Now it gets real for the U.S. as this probably means it been spreading for 3-4 weeks.

The person who died was a man in his 50s with underlying health conditions, and there was no evidence he contracted the virus through travel, health officials said. They suspect domestic "community spread" of the disease, a new phase for the United States that began this week on the West Coast.

https://www.nbcnews.com/news/us-news...s-say-n1145931

[MoValley John]

I had s colonoscopy, they used some Chinese laxatives to clean me out. Colonoscopy went well. I was starved, Following the procedure, I immediately ate a McRib and fries, went over to Long John Silvers and had two Fish and More meals, took a nap then Ishitrivers for a whole week! I blame theshits on the damn Chinese laxatives. Worst shitsever!

[SB Shock]

6 deaths in Washington State

[Shockm]

I had s colonoscopy, they used some Chinese laxatives to clean me out. Colonoscopy went well. I was starved, Following the procedure, I immediately ate a McRib and fries, went over to Long John Silvers and had two Fish and More meals, took a nap then Ishitrivers for a whole week! I blame theshits on the damn Chinese laxatives. Worst shitsever!

Thank you for that.

[SB Shock]

I read a larger discussion from the World Health Organization that one of the hypotheses they are considering is that children are secret carriers of 2019-nCov.

Ex-CDC director under Obama also talks about this.

https://nypost.com/2020/03/02/ex-cdc...irus-carriers/