Novo Nordisk’s Bloomington Plant Receives FDA OAI Designation Following Contamination and Compliance Issues

[rsmith]

Attention Wegovy/Ozempic fans.

Novo is the first GLP manufacturer and previously asserted that compounded versions of it's GLPs are dangerous because of risk for contamination/impurity.

The industry may recall that the aforementioned plant reportedly had unaddressed cases of contamination by “atypical extrinsic particles,” including cat and human hair that were found in vial stoppers, and reports of pest infestations found in classified areas.

Got hair?

Since this time, approximately 20 additional deviations related to hair contamination during 100% manual visual inspection have occurred.

Novo Nordisk’s Bloomington Plant Receives FDA OAI Designation Following Contamination and Compliance Issues | Pharmaceutical Commerce

The fallout is impacting partners Scholar Rock and Regeneron, both of whom have pending regulatory applications tied to the facility.

www.pharmaceuticalcommerce.com

 

[keangkong]

Maybe they can get the FDA off their back by saying that they're just selling it for research purposes.

 

[StonePny]

Every click-bait and hyped up story about "dangerous" compound and gray peps is in mainstream online news. This very pertinent story? pharmaceut/commerce and a few other medical news sources behind a pay wall.

 

[Airborne Daddy]

Every click-bait and hyped up story about "dangerous" compound and gray peps is in mainstream online news. This very pertinent story? pharmaceut/commerce and a few other medical news sources behind a pay wall.

Put that shit on World News Tonight and let them drop prices 90% GO GREY!

 

[StonePny]

Put that shit on World News Tonight and let them drop prices 90% GO GREY!

The pharma co's sponsor the news so it'll never happen.

 

[MsGizmo]

Attention Wegovy/Ozempic fans.

Novo is the first GLP manufacturer and previously asserted that compounded versions of it's GLPs are dangerous because of risk for contamination/impurity.

The industry may recall that the aforementioned plant reportedly had unaddressed cases of contamination by “atypical extrinsic particles,” including cat and human hair that were found in vial stoppers, and reports of pest infestations found in classified areas.

Got hair?

Since this time, approximately 20 additional deviations related to hair contamination during 100% manual visual inspection have occurred.

Novo Nordisk’s Bloomington Plant Receives FDA OAI Designation Following Contamination and Compliance Issues | Pharmaceutical Commerce

The fallout is impacting partners Scholar Rock and Regeneron, both of whom have pending regulatory applications tied to the facility.

www.pharmaceuticalcommerce.com

I've been saying it all along .. stuff from pharmacies is just as risky as anything else we take.

 

[nonyabizznez]

If hair in Ozempic/Wegovy shots actually grew hair their stock would go through the roof. Maybe then Novo could have afforded the $185 to keep their patent in Canada!

 

[StonePny]

If hair in Ozempic/Wegovy shots actually grew hair their stock would go through the roof. Maybe then Novo could have afforded the $185 to keep their patent in Canada!

This is so funny! 😆

 

[byefatlicia]

It's possible that grey peps are tested more and under more scrutiny. More eyes watching them consistently 🧐

 

[StonePny]

It's possible that grey peps are tested more and under more scrutiny. More eyes watching them consistently 🧐

I agree!

 

[keangkong]

It's possible that grey peps are tested more and under more scrutiny. More eyes watching them consistently 🧐

Let's be real: No one shows up to monitor what's happening at the facilities that manufacture grey peptides. The Chinese version of the FDA does not visit these manufacturers. By manufacture, I'm referring to both creating the API and the lyophilization. Although Novo did poorly at an FDA inspection, at least the facility has FDA inspections. Janoshik and Peptide Tests will both describe the limitations of what their tests reveal. If we had to inject these drugs intravenously, where there are far more dangers of infection, I wouldn't use grey peptides. I'll poke fun at Novo because they look bad after exaggerating claims about the dangers of the grey market. But I'd no concerns about the safety of their manufacturing practices.

By the way, I believe Novo is not the first manufacturer of GLP-1 drugs; at a minimum, semaglutide is not the first GLP-1 drug approved by the FDA. Semaglutide is the first GLP-1 drug that led to weight loss typically exceeding 10% of a body's weight.

In general, for weight loss, people shouldn't be taking semaglutide. (I can't comment on diabetes.) A person trying to lose weight through a GLP-1 drug should be using something stronger.

 

[byefatlicia]

Let's be real: No one shows up to monitor what's happening at the facilities that manufacture grey peptides. The Chinese version of the FDA does not visit these manufacturers. By manufacture, I'm referring to both creating the API and the lyophilization. Although Novo did poorly at an FDA inspection, at least the facility has FDA inspections. Janoshik and Peptide Tests will both describe the limitations of what their tests reveal. If we had to inject these drugs intravenously, where there are far more dangers of infection, I wouldn't use grey peptides. I'll poke fun at Novo because they look bad after exaggerating claims about the dangers of the grey market. But I'd no concerns about the safety of their manufacturing practices.

By the way, I believe Novo is not the first manufacturer of GLP-1 drugs; at a minimum, semaglutide is not the first GLP-1 drug approved by the FDA. Semaglutide is the first GLP-1 drug that led to weight loss typically exceeding 10% of a body's weight.

In general, for weight loss, people shouldn't be taking semaglutide. (I can't comment on diabetes.) A person trying to lose weight through a GLP-1 drug should be using something stronger.

Okay, but how many Maunjaro or Zepbound users are double checking pharma quality on the Daily? That's all I'm saying.