KEY PRODUCTS
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
01 1Apex Healthcare Limited
01 1BUPIVACAINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Blank
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42324
Submission : 2025-08-21
Status : Active
Type : II
20
Apex Healthcare Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
They are recognized for Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
One of their notable products is BUPIVACAINE HYDROCHLORIDE USP, with a corresponding US DMF Number 42324.
Remarkably, this DMF maintains an Active status since its submission on August 21, 2025, highlighting commitment to regulatory compliance.
