Is MOLCLONE LABS PRIVATE LIMITED FDA approved?

MOLCLONE 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 MOLCLONE LABS PRIVATE LIMITED's drugs manufactured?

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

What drugs does MOLCLONE LABS PRIVATE LIMITED make?

3 products are listed under MOLCLONE 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.

MOLCLONE LABS PRIVATE LIMITED

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

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Registered sites: 1
Active NDC listings: 3
Live patents: 0
Countries: 1
Base: India

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
MOLCLONE LABS PRIVATE LIMITED	2/220, Kundru Medu Street, Sirumathur Village, Padappai, Sriperumbudur Taluk, Kanchipuram District, Chennai, Tamil Nadu 601301, India (IND)	Active ingredient (API) manufacture	3011571416650863256

Catalogue

Drug listings by form and route

3 active NDC listings: 3 bulk ingredient. By marketing category: BULK INGREDIENT 2, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 1.

Dosage form	NDCs
powder	3

Route	NDCs

Labeller name on the listing	NDCs
molclone labs private limited	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	LEVOMEFOLATE CALCIUM	powder	69723-002BULK INGREDIENT
-	Leucovorin Calcium	powder	69723-003BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	PENTOSAN POLYSULFATE SODIUM	powder	69723-001BULK INGREDIENT

Neighbours

Registered in the same town

Par Health USA, LLCChennai, IND · 2 sites
NATCO PHARMA LIMITEDChennai, IND
Pharmazell (India) Private LimitedChennai, IND
Novitium Pharma LLCChennai, IND
FOURRTS INDIA LABORATORIES PRIVATE LIMITEDChennai, IND
INGA PHARMACEUTICALSChennai, IND
InterMed Laboratories Private LimitedCHENNAI, IND

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Enquiry

Common questions

Is MOLCLONE LABS PRIVATE LIMITED FDA approved?: MOLCLONE 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 MOLCLONE LABS PRIVATE LIMITED's drugs manufactured?: The FDA register lists Chennai. Registered operations: active ingredient (API) manufacture.
What drugs does MOLCLONE LABS PRIVATE LIMITED make?: 3 products are listed under MOLCLONE 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.