Is Concord Biotech Limited FDA approved?

Concord Biotech Limited holds 3 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 Concord Biotech Limited's drugs manufactured?

The FDA register lists Ahmedabad; Kheda. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does Concord Biotech Limited make?

42 products are listed under Concord Biotech Limited in the openFDA NDC Directory, most often as powder; capsule; tablet, delayed release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Concord Biotech Limited

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

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Registered sites: 3
Active NDC listings: 42
Labeller names: 3
Live patents: 0
Countries: 1
Base: India

Authorisation

Registered operations

Analytical testing3Active ingredient (API) manufacture2Labelling1Finished drug manufacture1Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
CONCORD BIOTECH LIMITED	Unit - II, 297-298 / 2P At Valthera Ta. Dholka, Ahmedabad, Gujarat 382225, India (IND)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3012520698650996940
Concord Biotech Limited	Unit-I, 1482-1486, Trasad Road, Dholka, Ahmedabad, Gujarat 382225, India (IND)	Analytical testing, Active ingredient (API) manufacture	3004126703916708337
CONCORD BIOTECH LIMITED	UNIT-III, Plot No.84 and 668, Ranasar and Malawada, Limbasi Sojitra Road, Near Limbasi, Taluka- Matar,, Kheda,, Gujarat 387520, India (IND)	Analytical testing, Active ingredient (API) manufacture, Packaging	3020052335854352695

Catalogue

Drug listings by form and route

42 active NDC listings: 33 bulk ingredient, 9 human prescription drug. By marketing category: BULK INGREDIENT 33, ANDA 9.

Dosage form	NDCs
powder	33
capsule	4
tablet, delayed release	2
tablet, film coated	2
tablet	1

Route	NDCs
oral	9

Labeller name on the listing	NDCs
concord biotech limited	30
concord biotech limited	10
concord biotech ltd	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Anidulafungin	powder	68254-0013BULK INGREDIENT
-	CYCLOSPORINE	powder	68254-0008BULK INGREDIENT
-	Cyclosporine	powder	68254-2501BULK INGREDIENT
-	DACTINOMYCIN	powder	68254-0017BULK INGREDIENT
-	Endoxifen citrate	powder	68254-0024BULK INGREDIENT
-	Everolimus	powder	68254-6234BULK INGREDIENT
-	Fidaxomicin	powder	68254-0022BULK INGREDIENT
-	MIDOSTAURIN	powder	68254-0021BULK INGREDIENT
-	MYCOPHENOLATE MOFETIL	powder	68254-0015BULK INGREDIENT
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	capsule, oral	68254-5000ANDA
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	tablet, oral	68254-5003ANDA
-	MYCOPHENOLATE SODIUM	powder	68254-0007BULK INGREDIENT
-	Micafungin Sodium	powder	68254-0012BULK INGREDIENT
-	Mitomycin	powder	68254-0016BULK INGREDIENT
-	Mupirocin	powder	68254-0010BULK INGREDIENT
-	Mupirocin	powder	68254-2504BULK INGREDIENT
-	Mupirocin Calcium	powder	68254-0011BULK INGREDIENT
-	Mupirocin Calcium	powder	68254-2505BULK INGREDIENT
-	Mycophenolate Mofetil	powder	68254-0005BULK INGREDIENT
-	Mycophenolate Mofetil	powder	68254-2500BULK INGREDIENT
-	Mycophenolate Mofetil	powder	68254-2508BULK INGREDIENT
-	Mycophenolate Sodium	powder	68254-2503BULK INGREDIENT
-	Nystatin	powder	68254-2506BULK INGREDIENT
-	Pimecrolimus	powder	68254-0014BULK INGREDIENT
-	Polymyxin B Sulfate	powder	68254-2507BULK INGREDIENT
-	Pravastatin Sodium	powder	68254-0004BULK INGREDIENT
-	Romidepsin	powder	68254-0009BULK INGREDIENT
-	Sirolimus	powder	68254-1006BULK INGREDIENT
-	TEMSIROLIMUS	powder	68254-6237BULK INGREDIENT
TERIFLUNOMIDE	TERIFLUNOMIDE	tablet, film coated, oral	68254-5010ANDA
TERIFLUNOMIDE	TERIFLUNOMIDE	tablet, film coated, oral	68254-5013ANDA
-	Tacrolimus	powder	68254-0002BULK INGREDIENT
-	Tacrolimus	powder	68254-0020BULK INGREDIENT
-	Tacrolimus	powder	68254-2502BULK INGREDIENT
Tacrolimus	Tacrolimus	capsule, oral	68254-5004ANDA
Tacrolimus	Tacrolimus	capsule, oral	68254-5005ANDA
Tacrolimus	Tacrolimus	capsule, oral	68254-5006ANDA
-	Tacrolimus Premix 20 %	powder	68254-0019BULK INGREDIENT
-	Vancomycin hydrochloride	powder	68254-0006BULK INGREDIENT
-	Voclosporin	powder	68254-0023BULK INGREDIENT
mycophenolic acid	mycophenolic acid	tablet, delayed release, oral	68254-5001ANDA
mycophenolic acid	mycophenolic acid	tablet, delayed release, oral	68254-5002ANDA

Neighbours

Registered in the same town

Zydus Lifesciences LimitedAhmedabad, IND · 7 sites
Amneal Pharmaceuticals of New York, LLCAhmedabad, IND · 6 sites
Intas Pharmaceuticals LimitedAhmedabad, IND · 3 sites
DISHMAN CARBOGEN AMCIS LIMITEDAhmedabad, IND · 2 sites
Baxter Healthcare CorporationAhmedabad, IND
Piramal Healthcare (Canada) LimitedAhmedabad, IND
Hospira, Inc.Ahmedabad, IND
Emcure Pharmaceuticals LimitedAhmedabad, IND
Cadila Pharmaceuticals LimitedAhmedabad, IND
Unimark Remedies LimitedAHMEDABAD, IND
ALMON HEALTHCARE PRIVATE LIMITEDAHMEDABAD, IND
Ami Drugs Private LimitedAhmedabad, IND

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Enquiry

Common questions

Is Concord Biotech Limited FDA approved?: Concord Biotech Limited holds 3 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 Concord Biotech Limited's drugs manufactured?: The FDA register lists Ahmedabad; Kheda. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Concord Biotech Limited make?: 42 products are listed under Concord Biotech Limited in the openFDA NDC Directory, most often as powder; capsule; tablet, delayed release. 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.