Is Swiss-American CDMO, LLC FDA approved?

Swiss-American CDMO, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Swiss-American CDMO, LLC's drugs manufactured?

The FDA register lists Carrollton, TX. Registered operations: finished drug manufacture.

What drugs does Swiss-American CDMO, LLC make?

15 products are listed under Swiss-American CDMO, LLC in the openFDA NDC Directory, most often as cream; lotion; gel. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Swiss-American CDMO, LLC

Data as of 24 Sept 2026 · How to read this entry

Request a quote Claim this profile

Registered sites: 1
Active NDC listings: 15
Live patents: 0
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Swiss-American CDMO, LLC	2055 Luna Rd., Suite 126, Carrollton, Texas (TX) 75006, United States (USA)	Finished drug manufacture	3001451826080170933

Catalogue

Drug listings by form and route

15 active NDC listings: 15 human otc drug. By marketing category: OTC MONOGRAPH DRUG 15.

Dosage form	NDCs
cream	7
lotion	6
gel	1
spray	1

Route	NDCs
topical	15

Labeller name on the listing	NDCs
swiss-american cdmo, llc	15

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Chemical Sunscreen SPF50	octisalate, avobenzone, homosalate, octocrylene sunscreen	spray, topical	60232-0043OTC MONOGRAPH DRUG
Chemical Sunscreen SPF50 with Antipollution	homosalate, octocrylene, avobenzone, octisalate sunscreen	lotion, topical	60232-4400OTC MONOGRAPH DRUG
Image Clear Cell Acne Spot Treatment	salicylic acid acne gel	gel, topical	60232-5022OTC MONOGRAPH DRUG
Image MD Restoring Lip Enhancer SPF15	sunscreen	cream, topical	60232-3537OTC MONOGRAPH DRUG
Image Prevention Plus Professional Ultimate Protection Moisturizer SPF50	homosalate, octisalate, octocrylene, zinc oxide sunscreen	cream, topical	60232-1026OTC MONOGRAPH DRUG
Image Prevention Refiner Primer SPF50	Zinc oxide, titanium dioxide sunscreen	cream, topical	60232-1830OTC MONOGRAPH DRUG
Image Skincare Prevention Plus Daily Ultimate Protection	homosalate, octisalate, octocrylene, zinc oxide sunscreen	cream, topical	60232-1022OTC MONOGRAPH DRUG
Physical Sunscreen SPF50 80 min WR 159-100	titanium dioxide, titanium dioxide sunscreen	lotion, topical	60232-0044OTC MONOGRAPH DRUG
Private Label Antifungal Barrier Cream	2% Miconazole Nitrate Cream	cream, topical	60232-0009OTC MONOGRAPH DRUG
Private Label Antifungal Barrier Cream	miconazole nitrate antifungal cream	cream, topical	60232-0046OTC MONOGRAPH DRUG
Private Label Moisturizing Oil Free Paraben Free SPF43	Sunscreen	lotion, topical	60232-0007OTC MONOGRAPH DRUG
Private Label SPF 50 80 min Water Resistant	homosalate, octisalate, zinc oxide sunscreen	cream, topical	60232-0035OTC MONOGRAPH DRUG
Private Label SPF45 Water Resistant Paraben Free Sunscreen	Octinoxate, Octisalate, Zinc Oxide Sunscreen	lotion, topical	60232-0006OTC MONOGRAPH DRUG
Private Label Sunscreen SPF35 40min WR RE126-202	homosalate, zinc oxide sunscreen	lotion, topical	60232-0036OTC MONOGRAPH DRUG
Private Label Super Light Oil-Free SPF45	2.75% Octinsalate, 7.50% Octinoxate, 8.00% Zinc Oxide Sunscreen	lotion, topical	60232-0008OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Certified Laboratories, LLCCarrollton, TX
Mary Kay Inc.Carrollton, TX
Micelle Laboratories IncorporatedCarrollton, TX

Compare

Comparable companies in United States

Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals1 site · 4,853 NDC
NuCare Pharmaceuticals,Inc.1 site · 1,393 NDC
Greer Laboratories, Inc.1 site · 1,328 NDC
ASCLEMED USA INC. DBA ENOVACHEM1 site · 789 NDC
Golden State Medical Supply Inc.1 site · 670 NDC
Rising Pharma Holdings, Inc.1 site · 532 NDC
HF Acquisition Co LLC1 site · 363 NDC
ANI Pharmaceuticals, Inc.1 site · 299 NDC
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 site · 273 NDC
Newton Laboratories, Inc.1 site · 271 NDC

Enquiry

Common questions

Is Swiss-American CDMO, LLC FDA approved?: Swiss-American CDMO, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Swiss-American CDMO, LLC's drugs manufactured?: The FDA register lists Carrollton, TX. Registered operations: finished drug manufacture.
What drugs does Swiss-American CDMO, LLC make?: 15 products are listed under Swiss-American CDMO, LLC in the openFDA NDC Directory, most often as cream; lotion; gel. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.