Is LGM Pharma Solutions, LLC FDA approved?

LGM Pharma Solutions, LLC holds 4 FDA-registered establishments 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 LGM Pharma Solutions, LLC's drugs manufactured?

The FDA register lists Colorado Springs, CO; ERLANGER, KY; Irvine, CA; Rosenberg, TX. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling.

What drugs does LGM Pharma Solutions, LLC make?

16 products are listed under LGM Pharma Solutions, LLC in the openFDA NDC Directory, most often as tablet; capsule; tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

LGM Pharma Solutions, LLC

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

Request a quote Claim this profile

Registered sites: 4
Active NDC listings: 16
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing2Labelling2Finished drug manufacture3Packaging2Relabelling1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
LGM PHARMA SOLUTIONS, LLCRegistrant: LGM PHARMA, LLC	1815 East Cheyenne Rd., Colorado Springs, Colorado (CO) 80905, United States (USA)	Finished drug manufacture	3017612126117552358
LGM PHARMA, LLC	2758 CIRCLEPORT DR, ERLANGER, Kentucky (KY) 41018, United States (USA)	Relabelling	3012048333118999188
LGM Pharma Solutions, LLC	17802 Gillette Avenue, Irvine, California (CA) 92614, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3017140477117549200
LGM Pharma Solutions, LLC	1000 Cole Avenue, Rosenberg, Texas (TX) 77471, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3017140511117549198

Catalogue

Drug listings by form and route

16 active NDC listings: 15 human prescription drug, 1 human otc drug. By marketing category: ANDA 11, UNAPPROVED DRUG OTHER 5.

Dosage form	NDCs
tablet	7
capsule	5
tablet, film coated	3
powder, for solution	1

Route	NDCs
oral	16

Labeller name on the listing	NDCs
lgm pharma solutions, llc	16

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Ascomp with Codeine	Butalbital, Aspirin, Cafeine, and Codeine Phosphate	capsule, oral	79739-6094ANDA
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	capsule, oral	79739-6670ANDA
Butalbital, Acetaminophen, and Caffeine	Butalbital, Acetaminophen, and Caffeine	tablet, oral	79739-7320ANDA
Butalbital, Aspirin, and Caffeine	Butalbital, Aspirin, and Caffeine	capsule, oral	79739-7192ANDA
Glycopyrrolate	Glycopyrrolate	tablet, oral	79739-7097ANDA
Nabumetone 1000 mg	Nabumetone	tablet, film coated, oral	79739-7078ANDA
Nabumetone 500 mg	Nabumetone	tablet, film coated, oral	79739-7076ANDA
Nabumetone 750 mg	Nabumetone	tablet, film coated, oral	79739-7077ANDA
Polyethylene Glycol 3350, NF Powder for Solution, Laxative	Polyethylene Glycol 3350, NF Powder for Solution, Laxative	powder, for solution, oral	79739-7116ANDA
Thyroid	thyroid, unspecified	tablet, oral	79739-7370UNAPPROVED DRUG OTHER
Thyroid	thyroid, unspecified	tablet, oral	79739-7371UNAPPROVED DRUG OTHER
Thyroid	thyroid, unspecified	tablet, oral	79739-7372UNAPPROVED DRUG OTHER
Thyroid	thyroid, unspecified	tablet, oral	79739-7373UNAPPROVED DRUG OTHER
Thyroid	thyroid, unspecified	tablet, oral	79739-7374UNAPPROVED DRUG OTHER
Ursodiol 200 mg	Usodiol	capsule, oral	79739-7143ANDA
Ursodiol 400 mg	Usodiol	capsule, oral	79739-7144ANDA

Neighbours

Registered in the same town

Spectrum Pharmaceuticals, Inc.Irvine, CA · 2 sites
Siegfried USA, LLCIrvine, CA
Allergan, Inc.Irvine, CA
North American Science Associates, LLCIrvine, CA
B. Braun US Pharmaceutical Manufacturing LLCIrvine, CA
StateServ Medical LLCColorado Springs, CO
General Air Service & Supply Co.Colorado Springs, CO
Bioelements, IncColorado Springs, CO
Noble Panacea Labs, Inc.Irvine, CA

Compare

Comparable companies in United States

Hikma Pharmaceuticals USA Inc.4 sites · 763 NDC
Church & Dwight Co., Inc.4 sites · 157 NDC
Sterling Pharmaceutical Services, LLC4 sites · 104 NDC
Bausch & Lomb Ireland Limited4 sites · 92 NDC
Grifols Therapeutics LLC4 sites · 53 NDC
Gilead Sciences, Inc.4 sites · 51 NDC
Nice-Pak Products, LLC4 sites · 48 NDC
HOVIONE FARMACIENCIA, S.A.4 sites · 47 NDC
Pacific Medical Industries Ltd4 sites · 41 NDC
United Therapeutics Corporation4 sites · 40 NDC

Enquiry

Common questions

Is LGM Pharma Solutions, LLC FDA approved?: LGM Pharma Solutions, LLC holds 4 FDA-registered establishments 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 LGM Pharma Solutions, LLC's drugs manufactured?: The FDA register lists Colorado Springs, CO; ERLANGER, KY; Irvine, CA; Rosenberg, TX. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling.
What drugs does LGM Pharma Solutions, LLC make?: 16 products are listed under LGM Pharma Solutions, LLC in the openFDA NDC Directory, most often as tablet; capsule; tablet, film coated. 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.