Is SOFTGEL HEALTHCARE PRIVATE LIMITED FDA approved?

SOFTGEL HEALTHCARE PRIVATE LIMITED holds 2 FDA-registered establishments 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 SOFTGEL HEALTHCARE PRIVATE LIMITED's drugs manufactured?

The FDA register lists Chengalpattu. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does SOFTGEL HEALTHCARE PRIVATE LIMITED make?

38 products are listed under SOFTGEL HEALTHCARE PRIVATE LIMITED in the openFDA NDC Directory, most often as capsule, liquid filled; capsule; capsule, gelatin coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

SOFTGEL HEALTHCARE PRIVATE LIMITED

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

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Registered sites: 2
Active NDC listings: 38
Labeller names: 3
Live patents: 0
Countries: 1
Base: India

Authorisation

Registered operations

Analytical testing2Labelling2Finished drug manufacture2Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
SOFTGEL HEALTHCARE PRIVATE LIMITED	Survey No. 20/1, Vandalur Kelambakkam Road, Pudupakkam, Chengalpattu, Tamilnadu 603103, India (IND)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3006381009676666501
SOFTGEL HEALTHCARE PRIVATE LIMITED	Plot Nos. 9, 10 & 44, Onehub, Kunnapattu, Chengalpattu, Tamilnadu 603105, India (IND)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3041045488771751750

Catalogue

Drug listings by form and route

38 active NDC listings: 36 human otc drug, 2 human prescription drug. By marketing category: OTC MONOGRAPH DRUG 36, ANDA 2.

Dosage form	NDCs
capsule, liquid filled	32
capsule	4
capsule, gelatin coated	2

Route	NDCs
oral	38

Labeller name on the listing	NDCs
softgel healthcare private limited	16
softgel healthcare pvt ltd	15
softgel healthcare private limited	7

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Acetaminophen	Acetaminophen	capsule, liquid filled, oral	35916-0183OTC MONOGRAPH DRUG
Acetaminophen , Aspirin and Caffeine	Acetaminophen , Aspirin and Caffeine	capsule, oral	35916-0709OTC MONOGRAPH DRUG
Acetaminophen , Caffeine and pyrilamine maleate	Acetaminophen , Caffeine and pyrilamine maleate	capsule, liquid filled, oral	35916-0710OTC MONOGRAPH DRUG
Acetaminophen , Caffeine and pyrilamine maleate	Acetaminophen , Caffeine and pyrilamine maleate	capsule, oral	35916-1234OTC MONOGRAPH DRUG
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg	Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl	capsule, liquid filled, oral	35916-0188OTC MONOGRAPH DRUG
Acetaminophen, Dextromethorphan HBr ,Guaifenesin	Acetaminophen, Dextromethorphan HBr ,Guaifenesin	capsule, liquid filled, oral	35916-0184OTC MONOGRAPH DRUG
Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate	Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate	capsule, liquid filled, oral	35916-0185OTC MONOGRAPH DRUG
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate	Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate	capsule, liquid filled, oral	35916-0154OTC MONOGRAPH DRUG
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate	Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate	capsule, liquid filled, oral	35916-0189OTC MONOGRAPH DRUG
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	capsule, liquid filled, oral	35916-0155OTC MONOGRAPH DRUG
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	capsule, liquid filled, oral	35916-0917OTC MONOGRAPH DRUG
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride	capsule, liquid filled, oral	35916-0167OTC MONOGRAPH DRUG
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride	capsule, liquid filled, oral	35916-0186OTC MONOGRAPH DRUG
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr	Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr	capsule, liquid filled, oral	35916-0166OTC MONOGRAPH DRUG
Acetominophen, Dextromethorphan hydrobromide	Acetaminophen, Dextromethorphan hydrobromide	capsule, liquid filled, oral	35916-2211OTC MONOGRAPH DRUG
Bismuth subsalicylate	Bismuth subsalicylate	capsule, liquid filled, oral	35916-0234OTC MONOGRAPH DRUG
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	capsule, liquid filled, oral	35916-0435OTC MONOGRAPH DRUG
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	capsule, liquid filled, oral	35916-0436OTC MONOGRAPH DRUG
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	capsule, liquid filled, oral	35916-0438OTC MONOGRAPH DRUG
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	capsule, liquid filled, oral	35916-0470OTC MONOGRAPH DRUG
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	capsule, liquid filled, oral	35916-0471OTC MONOGRAPH DRUG
Dextromethorphan Hbr,Guaifenesin	Dextromethorphan Hbr,Guaifenesin	capsule, liquid filled, oral	35916-0760OTC MONOGRAPH DRUG
Dextromethorphan Hydrobromide	Dextromethorphan Hydrobromide	capsule, liquid filled, oral	35916-0461OTC MONOGRAPH DRUG
Diphenhydramine hydrochloride	Diphenhydramine hydrochloride	capsule, liquid filled, oral	35916-0472OTC MONOGRAPH DRUG
Docusate Sodium and Sennosides	Docusate Sodium and Sennosides	capsule, gelatin coated, oral	35916-0453OTC MONOGRAPH DRUG
Docusate Sodium and Sennosides	Docusate Sodium and Sennosides	capsule, gelatin coated, oral	35916-0454OTC MONOGRAPH DRUG
Docusate Sodium and Sennosides	Docusate Sodium and Sennosides	capsule, liquid filled, oral	35916-0477OTC MONOGRAPH DRUG
Guaifenesin,Dextromethorphan Hbr	Guaifenesin,Dextromethorphan Hbr	capsule, liquid filled, oral	35916-0759OTC MONOGRAPH DRUG
Ibuprofen	Ibuprofen	capsule, liquid filled, oral	35916-0989OTC MONOGRAPH DRUG
Pamabrom	Pamabrom	capsule, liquid filled, oral	35916-1654OTC MONOGRAPH DRUG
Sennosides	Sennosides	capsule, liquid filled, oral	35916-0423OTC MONOGRAPH DRUG
Sennosides	Sennosides	capsule, liquid filled, oral	35916-1936OTC MONOGRAPH DRUG
Simethicone	Simethicone	capsule, liquid filled, oral	35916-1938OTC MONOGRAPH DRUG
Simethicone	Simethicone	capsule, liquid filled, oral	35916-1939OTC MONOGRAPH DRUG
Simethicone	Simethicone	capsule, liquid filled, oral	35916-1940OTC MONOGRAPH DRUG
Simethicone	Simethicone	capsule, liquid filled, oral	35916-1942OTC MONOGRAPH DRUG
icosapent ethyl	icosapent ethyl	capsule, oral	35916-1592ANDA
icosapent ethyl	icosapent ethyl	capsule, oral	35916-1738ANDA

Neighbours

Registered in the same town

Sun Pharmaceutical Industries LimitedChengalpattu, IND
Strides Pharma Science LimitedChengalpattu, IND
AMRUTANJAN HEALTH CARE LIMITEDChengalpattu, IND
Orchid Pharma LimitedChengalpattu, IND

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Enquiry

Common questions

Is SOFTGEL HEALTHCARE PRIVATE LIMITED FDA approved?: SOFTGEL HEALTHCARE PRIVATE LIMITED holds 2 FDA-registered establishments 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 SOFTGEL HEALTHCARE PRIVATE LIMITED's drugs manufactured?: The FDA register lists Chengalpattu. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does SOFTGEL HEALTHCARE PRIVATE LIMITED make?: 38 products are listed under SOFTGEL HEALTHCARE PRIVATE LIMITED in the openFDA NDC Directory, most often as capsule, liquid filled; capsule; capsule, gelatin 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.