Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.

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01 1Apex Healthcare Limited
02 1Ajinomoto OmniChem N.V.
03 1AstraZeneca
04 1Atul Bioscience Ltd
05 2Aurore Life Sciences
06 1Charioteer
07 1Cipla
08 1Hetero Drugs
09 1Hubei Yitai Pharmaceutical Co. , Ltd.
10 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
11 2Mallinckrodt Pharmaceuticals
12 2Olon S.p.A
13 1Piramal Pharma Solutions
14 1Qidong Dongyue Pharmaceutical Co., Ltd.
15 1Quimica Sintetica
16 1Recordati
17 1ST Pharma
18 1Signa S.A. de C.V.
19 1Sun Pharmaceutical Industries Limited
20 4Teva Pharmaceutical Industries
21 1UQUIFA
22 1Viatris
23 2YUNG ZIP CHEMICAL INDUSTRIAL
24 1Zhejiang Zhebei Pharmaceutical
25 3Blank
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01 16ACYCLOVIR
02 1ACYCLOVIR (NON-STERILE, BULK FORM)
03 1ACYCLOVIR (PROCESS II)
04 1ACYCLOVIR A SUBSTANCE
05 2ACYCLOVIR DRUG SUBSTANCE
06 8ACYCLOVIR USP
07 1ACYCLOVIR USP (API)
08 1ACYCLOVIR USP (MICRONIZED), CODED 2524
09 1ACYCLOVIR USP [SITE KHAZIPALLY]
10 1ACYCLOVIR USP, BULK
11 1ACYCLOVIR, USP
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01 1Belgium
02 5China
03 7India
04 2Ireland
05 4Israel
06 3Italy
07 1Mexico
08 1South Korea
09 2Spain
10 2Taiwan
11 2U.S.A
12 1United Kingdom
13 3Blank
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01 20Active
02 14Inactive
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01 14Complete
02 20Blank
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 : 42067
Submission : 2025-07-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-21
DMF Number : 20203
Submission : 2007-01-12
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2015-03-03
Pay. Date : 2014-04-22
DMF Number : 10685
Submission : 1994-01-12
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2014-02-07
Pay. Date : 2014-01-29
DMF Number : 8584
Submission : 1990-05-25
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2014-05-29
Pay. Date : 2013-06-04
DMF Number : 10044
Submission : 1993-01-12
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-04-04
DMF Number : 16144
Submission : 2002-09-24
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2013-05-09
Pay. Date : 2013-04-26
DMF Number : 11896
Submission : 1996-03-18
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-11-19
DMF Number : 13277
Submission : 1998-10-22
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2014-05-20
Pay. Date : 2013-03-22
DMF Number : 19948
Submission : 2006-11-01
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10830
Submission : 1994-03-24
Status : Active
Type : II

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A CS-1353 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CS-1353, including repackagers and relabelers. The FDA regulates CS-1353 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CS-1353 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of CS-1353 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CS-1353 supplier is an individual or a company that provides CS-1353 active pharmaceutical ingredient (API) or CS-1353 finished formulations upon request. The CS-1353 suppliers may include CS-1353 API manufacturers, exporters, distributors and traders.
click here to find a list of CS-1353 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CS-1353 DMF (Drug Master File) is a document detailing the whole manufacturing process of CS-1353 active pharmaceutical ingredient (API) in detail. Different forms of CS-1353 DMFs exist exist since differing nations have different regulations, such as CS-1353 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CS-1353 DMF submitted to regulatory agencies in the US is known as a USDMF. CS-1353 USDMF includes data on CS-1353's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CS-1353 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CS-1353 suppliers with USDMF on PharmaCompass.
We have 24 companies offering CS-1353
Get in contact with the supplier of your choice: