Ranbaxy
Overview
Ranbaxy is a pharmaceutical company headquartered in Gurgaon, India, founded in 1961, with over 10,000 employees.
API / Drug Master Files
Ranbaxy holds 0 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- ACYCLOVIR DRUG SUBSTANCEInactive1996-10-08
FDA compliance signals
9 FDA enforcement records linked to this company.
- recall — Class II2015-08-12
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
- recall — Class II2014-03-05
Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
- recall — Class III2013-02-20
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
- recall — Class III2013-02-20
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
- recall — Class II2012-12-05
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
- recall — Class II2012-12-05
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
- recall — Class II2012-12-05
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
- recall — Class II2012-11-28
Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
- recall — Class III2012-07-11
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
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