Counterfeit GH

[Maxhardc]

TweetThe general dose for the Male - 1.3mg/day

there is allot of counterfeit and/or bovine growth hormone sold out there! The two biggest frauds I see is Lilly product sold out of Mexico - All of it is fake. Lilly can only sell to endocrinologist, and their price to foreign markets is about the same as its sold here in the USA. What we see out of Mexico is bovine GH sold with a fake Lilly label. Remember that GH is species specific.

Call Lilly directly for more information, and with your lot number. A contact there is Mark Hartman, MD 800/545-5979.

With GH sales, if it sounds "too good to be true", it probably is! GH will sell for about $80 for 4IU! Exactly what GH do you have and how did you obtain it?

When someone writes in saying they aren't getting results off GH, we always discover that they are taking one of the zillion counterfeits out there...

There counterfeit Genentech out of south africa; fake E.Lilly out of Mexico and France, (remember: our US companies export to those countries at about the same price they charge here in the USA); fake serostim (see the recent FDA alert); and several fakes out of China.

Max

[Governor]

Tweetdamn, good post.

[Maxhardc]

TweetIf the manufacturer name is not on there, it is fake.

There are many unscrupulous export agents in China that will send fake growth hormone to the US market place. They get away with it because as long as the bottle is not labeled with a manufacturers name, they are able to put anything in there they want.

On the other hand, if a manufacturers name and product description is on the bottle – And provided that the manufacturer has GMP documentation, you are getting legitimate human recombinant growth hormone.

In one case, an associate of mine physicially went to the city in China this particular group claimed their manufacturing plant was located. Upon arriving they only found a little office and a bunch of bull shit. Can you imagine the time wasted on these people?! But it has to be done with international drug purchases. You have to go through that much energy and time to assure QA and safety. I am concerned for patients with HIV who order from China, and we have to know what we are dealing with in those instances.

For a recombinant human growth hormone to be WTO (World Trade Organization) GMP compliant, they have to meet ICH (International Committee on Harmonization) standards. In the case of human growth hormone this includes, inter alia, developing a Regulatory Interaction Program Strategy; and filing the following Regulatory Documentation: IND, PMA, CTX/CTC, PLA, NDA, 510k, ANDA, DMF, and the associated supplements, amendments, and annual reports; submit periodic results of product ATP bioluminescence evaluations, meeting the following Regulatory Compliance: GMP, GLP, GCP Audits, and Standard Operating Procedures that meet the WTO TRIPS Pharmaceutical Import/Export Agreement; they must maintain Outsourcing of analytical quality control monitoring services as often as necessary during the drug development; maintain expanded monographs for their product; comply with CP (Chinese Pharmacopeia); validation project management which includes: Document Templates for Validation Deliverables, Preparation of Validation Plans and/or Protocols, Validation Test Script & Test Data Creation, Test Execution, Result Analysis & Documentation, Evaluation/Assessment of Validation Documents, Evaluation and/or Development of Applicable SOPs, Prospective & Retrospective Validations, On-site Training, Auditing Validation Practices, and publish GMP trends.

Information gathered in regulatory compliance is gathered into the following categories:
Manufacturing Controls
Sterile Product Controls
Active Pharmaceutical Ingredients (API)
Packaging and Labeling
Laboratory Controls
Medical Device-Critical

Plant inspection reports (FD483’s) are reviewed by the appropriate regulatory boards, and Investigator observations are reprinted “verbatim”, then objectively evaluated and analyzed, and information interpreted in light of the specific manufacturing facility and product.

The importance of complying with the Good Manufacturing Practice (GMP) regulations is critical.

You know it’s a fake if you see any of the following: generic labeling; lack of GMP certification together with the product you receive; or, missing Drug Insert (Clinical Pharmacology, Warnings, Drug Monograph, etc.) and Form/Methodology for reporting Adverse Reactions to the Drug.

No matter where you shop in the world for your pharmaceuticals, they must contain the aforementioned GMP, Name, Manufacturer, Lot Number, Exp. Date, Drug Insert, Adverse Reactions Filing procedures.

I know for a fact that China has only 3 manufacturers that meet this standard. And I know for a fact that at least one non-qualified manufacturer is using unscrupulous agents to export its fraudulent medication to Americans via Internet sales.

Prior to purchase, ask the agent to provide via email a copy of the GMP certificate, Manufacturer, Drug Insert, and Adverse Reactions filing data. If the agent comes up with ANY excuse for not providing this material, then rest assured, it IS FAKE! The manufacturers in China with legitimate pharmaceuticals will have no problem furnishing this information together with references.

Finally, verify the legitimacy of the potential product through the FDA log, (yes – they do keep track of the bogus international medications out there – they have to, it’s the law), UNIAIDS/WHO, and refer to the UNAIDS/WHO Pharmaceuticals and WTO TRIPS Agreement and Operational principles for good pharmaceutical procurement.

Final Note: IF IT SOUNDS TOO GOOD TO BE TRUE, IT PROBABLY IS!

Max