Is Synthokem Labs Private Limited FDA approved?

Synthokem Labs Private Limited holds 1 FDA-registered establishment in India. 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 Synthokem Labs Private Limited's drugs manufactured?

The FDA register lists Sangareddy. Registered operations: active ingredient (API) manufacture.

What drugs does Synthokem Labs Private Limited make?

5 products are listed under Synthokem Labs Private Limited in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Synthokem Labs Private Limited

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

Request a quote Claim this profile

Registered sites: 1
Active NDC listings: 5
Labeller names: 2
Live patents: 0
Countries: 1
Base: India

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Synthokem Labs Private Limited	Plot No. 222 to 224 & 235 to 237 Phase-II IDA Pashamylaram, Patancheru (Mandal), Sangareddy, Telangana 502319, India (IND)	Active ingredient (API) manufacture	3010770804650605491

Catalogue

Drug listings by form and route

5 active NDC listings: 5 bulk ingredient. By marketing category: BULK INGREDIENT 5.

Dosage form	NDCs
powder	5

Route	NDCs

Labeller name on the listing	NDCs
synthokem labs private limited	3
synthokem labs private limited	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	GUAIFENESIN	powder	58343-0130BULK INGREDIENT
-	GUAIFENISIN	powder	58343-0132BULK INGREDIENT
-	GUAIFENISIN	powder	58343-0136BULK INGREDIENT
-	METHOCARBAMOL	powder	58343-0138BULK INGREDIENT
-	Prazosin Hydrochloride	powder	58343-0140BULK INGREDIENT

Neighbours

Registered in the same town

Apitoria Pharma Private LimitedSangareddy, IND · 5 sites
Dr. Reddy's Laboratories LimitedSangareddy, IND · 3 sites
Arene Life Sciences Private LimitedSangareddy, IND · 3 sites
Viyash Scientific LimitedSangareddy, IND · 2 sites
Aurobindo Pharma LimitedSangareddy, IND · 2 sites
Honour Lab LimitedSangareddy, IND · 2 sites
Metrochem API Private LimitedSangareddy, IND · 2 sites
Biocon Biologics LimitedSangareddy, IND
Granules Pharmaceuticals Inc.Sangareddy, IND
Hetero Labs LimitedSangareddy, IND
Piramal Healthcare (Canada) LimitedSangareddy, IND
Cohance Lifesciences LimitedSangareddy, IND

Compare

Comparable companies in India

NURAY CHEMICALS PRIVATE LIMITED1 site · 105 NDC
Jubilant Biosys Limited1 site · 94 NDC
Maithri Drugs Private Limited1 site · 80 NDC
MSN Pharmachem Private Limited1 site · 54 NDC
STHREE CHEMICALS PRIVATE LIMITED1 site · 52 NDC
Dasami Lab Private Limited1 site · 48 NDC
AZICO BIOPHORE INDIA PRIVATE LIMITED1 site · 43 NDC
APOTHECON PHARMACEUTICALS PRIVATE LIMITED1 site · 38 NDC
Biophore India Pharmaceuticals Private Limited1 site · 38 NDC
Aurore Pharmaceuticals Private Limited1 site · 33 NDC

Enquiry

Common questions

Is Synthokem Labs Private Limited FDA approved?: Synthokem Labs Private Limited holds 1 FDA-registered establishment in India. 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 Synthokem Labs Private Limited's drugs manufactured?: The FDA register lists Sangareddy. Registered operations: active ingredient (API) manufacture.
What drugs does Synthokem Labs Private Limited make?: 5 products are listed under Synthokem Labs Private Limited in the openFDA NDC Directory, most often as powder. 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.