Is Orchid Pharma Limited FDA approved?

Orchid Pharma 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 Orchid Pharma Limited's drugs manufactured?

The FDA register lists Chengalpattu. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, packaging.

What drugs does Orchid Pharma Limited make?

5 products are listed under Orchid Pharma 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.

Orchid Pharma Limited

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

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Registered sites: 1
Active NDC listings: 5
Live patents: 2
Exclusivities: 1
Countries: 1
Base: India

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Orchid Pharma Limited	Plot Nos.121-128,128A-133,138-151&159-164, SIDCO Industrial Estate, Chengalpattu, Tamil Nadu 603110, India (IND)	Analytical testing, Active ingredient (API) manufacture, Labelling, Packaging	3003747558675829201

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
orchid pharma ltd	5

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
7687488	EXBLIFEPcefepime hydrochloride; enmetazobactam	substance, product	Dec 2027
11124526	EXBLIFEPcefepime hydrochloride; enmetazobactam	use	Nov 2034

Product	Exclusivity	Until
EXBLIFEPCEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM	GAIN Qualified infectious disease product (GAIN)	Feb 2034

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Cefazolin Sodium Sterile Bulk	powder	63785-104BULK INGREDIENT
-	Cefepime Hydrochloride	powder	63785-113BULK INGREDIENT
-	Cefpodoxime Proxetil	powder	63785-112BULK INGREDIENT
-	Ceftiofur Hydrochloride	powder	63785-115BULK INGREDIENT
-	Ceftiofur Sodium	powder	63785-105BULK INGREDIENT

Neighbours

Registered in the same town

SOFTGEL HEALTHCARE PRIVATE LIMITEDChengalpattu, IND · 2 sites
Sun Pharmaceutical Industries LimitedChengalpattu, IND
Strides Pharma Science LimitedChengalpattu, IND
AMRUTANJAN HEALTH CARE LIMITEDChengalpattu, IND

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Enquiry

Common questions

Is Orchid Pharma Limited FDA approved?: Orchid Pharma 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 Orchid Pharma Limited's drugs manufactured?: The FDA register lists Chengalpattu. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, packaging.
What drugs does Orchid Pharma Limited make?: 5 products are listed under Orchid Pharma 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.