Zach System is committed to providing Highly Customized Solutions for all your Development Programs.

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01 1ZACH System SA
02 2Axplora
03 1LGM Pharma
04 1Gonane Pharma
05 1Aarti Pharmalabs
06 1Bhavna Laboratories
07 1Willow Birch Pharma
08 1Curia
09 1ALP Pharm
10 1Aspire Lifesciences Pvt Ltd
11 2CHEMO
12 1CHEMO IBERICA SA
13 1Fine Organics
14 1Flax Laboratories
15 1Guangzhou Topwork Chemical
16 1HL Genomics
17 1Henan Lihua Pharmaceutical
18 2Industriale Chimica
19 1Maharshi Pharma Chem
20 1NEWCHEM SPA
21 1Nishchem International Pvt. Ltd
22 1Parth Antibiotics
23 1Pure Chem India
24 1Reliance Life Sciences Private Limited
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26 5STERIS Isomedix
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01 1WC-0099
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01 115308-0722
02 146439-8743
03 146439-8744
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Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-10-16
Pay. Date : 2024-10-08
DMF Number : 11105
Submission : 1994-09-26
Status : Active
Type : II
NDC Package Code : 60269-287
Start Marketing Date : 1998-03-09
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Bausch Health Korea Co., Ltd.
Registration Date : 2008-05-07
Registration Number : 4063-1-ND
Manufacturer Name : Zach system
Manufacturer Address : Zone Industrielle La Croix Cadeau Avrille, 49240, France
| Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26937
Submission : 2013-03-05
Status : Active
Type : II
NDC Package Code : 46439-8743
Start Marketing Date : 2012-04-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : EU |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26249
Submission : 2012-07-26
Status : Active
Type : II
Date of Issue : 2025-08-22
Valid Till : 2028-08-21
Written Confirmation Number : WC-0099
Address of the Firm :
NDC Package Code : 15308-0722
Start Marketing Date : 2011-06-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2024-03-14
Registration Number : Su289-18-ND
Manufacturer Name : Aarti Pharmalabs Limited
Manufacturer Address : Plot No. E–50, 50/1 & 59/1, Unit-IV, MIDC, Tarapur, Taluka & District-Palghar, 401 506, Maharashtra State, India.
| Available Reg Filing : ASMF |
Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-29
Pay. Date : 2014-03-20
DMF Number : 28031
Submission : 2014-03-07
Status : Active
Type : II
NDC Package Code : 65089-0037
Start Marketing Date : 1998-03-09
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-07-05
Pay. Date : 2023-01-24
DMF Number : 27717
Submission : 2013-11-11
Status : Active
Type : II
NDC Package Code : 46439-8744
Start Marketing Date : 2012-04-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : EU |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11264
Submission : 1994-12-16
Status : Inactive
Type : II

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PharmaCompass offers a list of Loteprednol Etabonate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Loteprednol Etabonate manufacturer or Loteprednol Etabonate supplier for your needs.
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A LOTEPREDNOL ESTABONATE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LOTEPREDNOL ESTABONATE, including repackagers and relabelers. The FDA regulates LOTEPREDNOL ESTABONATE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LOTEPREDNOL ESTABONATE API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A LOTEPREDNOL ESTABONATE supplier is an individual or a company that provides LOTEPREDNOL ESTABONATE active pharmaceutical ingredient (API) or LOTEPREDNOL ESTABONATE finished formulations upon request. The LOTEPREDNOL ESTABONATE suppliers may include LOTEPREDNOL ESTABONATE API manufacturers, exporters, distributors and traders.
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We have 30 companies offering LOTEPREDNOL ESTABONATE
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