Is Aspen Biopharma Labs Pvt Ltd FDA approved?

Aspen Biopharma Labs Pvt Ltd holds 2 FDA-registered establishments across 2 countries. 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 Aspen Biopharma Labs Pvt Ltd's drugs manufactured?

At registered sites in India, the United States. The FDA register lists Medchal Malkajgiri; Spanish Fork, UT. Registered operations: active ingredient (API) manufacture, finished drug manufacture.

What drugs does Aspen Biopharma Labs Pvt Ltd make?

3 products are listed under Aspen Biopharma Labs Pvt Ltd in the openFDA NDC Directory, most often as liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Aspen Biopharma Labs Pvt Ltd

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

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Registered sites: 2
Active NDC listings: 3
Live patents: 0
Countries: 2
Base: India

Authorisation

Registered operations

Active ingredient (API) manufacture1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Aspen Biopharma Labs Pvt Ltd	Plot No 10, Biotech Park Phase-II, Lalgadi Malakpet Village,Turkapally, Shameerpet Mandal, Medchal Malkajgiri, Telangana 500078, India (IND)	Active ingredient (API) manufacture	3012796281869684734
Aspen Global	999 East 1950 North, Spanish Fork, Utah (UT) 84660, United States (USA)	Finished drug manufacture	3027683877058539027

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human prescription drug. By marketing category: UNAPPROVED DRUG OTHER 3.

Dosage form	NDCs
liquid	3

Route	NDCs
topical	3

Labeller name on the listing	NDCs
aspen medical llc	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
SODIUM SULFACETAMIDE, SULFUR	Sodium Sulfacetamide 10%, Sulfur 5%	liquid, topical	87026-202UNAPPROVED DRUG OTHER
SODIUM SULFACETAMIDE, SULFUR	Sodium Sulfacetamide 8% Sulfur 4%	liquid, topical	87026-203UNAPPROVED DRUG OTHER
SODIUM SULFACETAMIDE, SULFUR	Sodium Sulfacetamide 9.8% Sulfur 4.8%	liquid, topical	87026-205UNAPPROVED DRUG OTHER

Neighbours

Registered in the same town

Analys Lab Private LimitedMedchal Malkajgiri, IND
Aragen Life Sciences LimitedMedchal Malkajgiri, IND

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Enquiry

Common questions

Is Aspen Biopharma Labs Pvt Ltd FDA approved?: Aspen Biopharma Labs Pvt Ltd holds 2 FDA-registered establishments across 2 countries. 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 Aspen Biopharma Labs Pvt Ltd's drugs manufactured?: At registered sites in India, the United States. The FDA register lists Medchal Malkajgiri; Spanish Fork, UT. Registered operations: active ingredient (API) manufacture, finished drug manufacture.
What drugs does Aspen Biopharma Labs Pvt Ltd make?: 3 products are listed under Aspen Biopharma Labs Pvt Ltd in the openFDA NDC Directory, most often as liquid. 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.