FDA Application

Interloop Solutions & Consultancy Company is pleased to provide advice and prepare documents. Food Product Code, Cosmetic Product Code and Drug Product Code. We are ready to take care of every step until your product is completely registered.

Food and Drug Administration (FDA)

Take Our Help In Filing Your FDA Application

The Food and Drug Administration (FDA) is a federal agency under the Ministry of Public Health. Its primary responsibility is to protect public health and ensure their safety. Thus, it controls the manufacturing of drugs (including animal drugs), cosmetics, medical devices that help diagnose diseases, biological products, dietary supplements, and food additives. If your business manufactures any of these products, make sure that you file an FDA application form. Talk to us to get expert guidance about the FDA registration process.

What happens if your product does not have an FDA registration in Singapore?

The agency has regulatory authority to act when safety issues arise, limiting your product exports to the United States. So, you must conduct large-scale clinical trials that demonstrate the efficacy and safety of the product your company is making and then file an FDA application for approval.

If you manufacture drugs, you must submit data about clinical pharmacology, microbiology, toxicology, chemistry, and manufacturing. Also, mention the planned product labeling to communicate reliable information to healthcare professionals and, thus, the public.

What are the types of Applications?

New Drug Application

The sponsor of a new drug submits this to the FDA once adequate evidence on the drug’s safety and effectiveness is available. The FDA then grants marketing approval for the new drug. The NDA should contain data from certain technical viewpoints for review. For internal tracking, the concerned authorities assigned an NDA number to each of these applications.

Investigational New Drug

Such an application is filed to get FDA’s authorization for administering an investigational drug to humans. The sponsor needs to ship such a drug to clinical investigators in many states to get FDA approval. But before that, the manufacturer must file an FDA application to get an exemption from the legal requirement.

Abbreviated New Drug Application

It is submitted to the Center for Drug Evaluation and Research, Office of Generic Drugs, to review and approve a generic drug product. The ANDAs generally do not include preclinical (animal) & clinical (human) data to establish the highest safety standards. Instead, such an FDA applicant should scientifically demonstrate that the product is bioequivalent; performs in the same way as the innovator drug.

Biologic License Application

All biological products need marketing approval under the provisions of the Public Health Service Act. A firm manufacturing a biologic must have a license for the product’s export. This license application contains information on the chemistry, manufacturing processes, clinical pharmacology, pharmacology, and the medical effects of the product.

Over-the-Counter Drugs

These drugs are available to consumers without a prescription. Having over 80 therapeutic categories, these range from acne to weight control drug products. The Center for Drug Evaluation and Research oversees OTC drugs to ensure that they are correctly labeled, and their benefits are more than their risks.

Our Services

Request FDA Food Product Code

13 Digits

Request FDA Cosmetic Product Code

10 Digits

Request FDA Drug
Product Code

13 Digits

What is an FDA Product Code?

It’s a seven-character set of letters and numbers that describes a specific product and helps the FDA classify and review imports. Each product code should match the actual product name or product description per the invoice. The letters and numbers represent five components–Class, Subclass, Industry Code, Process Indicator Code, and Product.

Other Services:

Get FDA Food Product Code

New food additives and color additives used in food, cosmetics, drugs, and some medical devices require FDA approval in Singapore. The manufacturer of such a product needs to put it through relevant testing so that the additive is safe for consumption.

Further, every batch of high-risk colors requires FDA color batch certification. Products with unapproved color additives are adulterated under the Federal Food, Drug, and Cosmetic Act.

Get FDA Drug Product Code

Whether or not a new drug product requires FDA approval depends on whether the new drug conforms to an over-the-counter (OTC) monograph. Over-The-Counter monographs set conditions under which the FDA pre-determines a drug to be safe and effective. If a drug conforms to the monograph, it can be marketed without FDA approval.

However, the drug will require FDA approval if it does not comply with a monograph. In such a case, drug manufacturers should conduct animal, lab, and human clinical testing and submit this data to the agency for approval.

FDA Cosmetic Product Code

Each code has a two-digit number indicating the general category and a specific product type letter. So, if ‘Baby Products’ are listed in category ‘01’ and ‘Baby Shampoos’ are listed as item ‘A’, the Product Category Code for a Baby Shampoo is ‘01A.’

Note that Cosmetic companies do not require FDA registration. But their cosmetics need to be safe for their intended use. Specific claims made in cosmetic labeling cause the FDA to establish the product as a drug. In these cases, an FDA approval is required.

Get FDA Approval of Medical Devices

All medical devices fall into three risk-based categories: Class I, Class II, & Class III. Class III devices have the highest risk level and need FDA pre-market approval. For that, Class III device manufacturers need to demonstrate the safety and effectiveness of the product to the FDA.

Class I and II devices do not need any FDA approval. Also, unless these are exempt under the Federal Food, Drug, and Cosmetic Act, such companies must submit the pre-market notification (510(k)) to the FDA.

Things to Note:

All device establishments must have an FDA registration and list their devices. And the Interloop team helps you in filing the FDA application form. Note that registration or listing does not indicate an FDA approval of the establishment.
The manufacturer can only put the ‘FDA Approved’ logo on the product’s labeling only if they have received a letter from the FDA confirming the approval.
You must be wondering how the FDA enforces its requirements when most products do not require pre-market approval: it conducts routine facility inspections and randomized shipment inspections at the U.S. border.

Contact us to get all the help with the documentation needed for filing the FDA application form. We help you meet your product’s FDA approval needs in Singapore. Give us a call NOW!

PROCESS

1. Registered production or importing cosmetics, food, supplements

Registered production or import location Which the location have to confirmed by the Ministry of Public Health

2. Registration of E-submission system

Online register and apply for a license from the Ministry of Public Health.

3. registration of LPI system

LPI (License per Invoice) is the certificate for import the health products into Thailand, as shown in the invoice (each time imported). Food and Drug Administration (FDA) issued LPI to importers of health products to use to engage in importing health products through customs clearance.