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CEP/COS
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JDMF
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Australia
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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API SUPPLIERS
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USDMF
Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
GDUFA
DMF Review : Complete
Rev. Date : 2024-10-16
Pay. Date : 2024-10-08
DMF Number : 11105
Submission : 1994-09-26
Status :
Type : II
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-05
Pay. Date : 2023-01-24
DMF Number : 27717
Submission : 2013-11-11
Status :
Type : II
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26937
Submission : 2013-03-05
Status :
Type : II
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 :
Type : II
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-29
Pay. Date : 2014-03-20
DMF Number : 28031
Submission : 2014-03-07
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Date of Issue : 2025-08-22
Valid Till : 2028-08-21
Written Confirmation Number : WC-0099
Address of the Firm : Plot No.E-50, 50/1 and 59/1, Unit-IV, MIDC, Tarapur-401506, Taluka: Palghar, Dis...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
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
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
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 ...
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Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
About the Company : Zach System, a subsidiary of Zambon Company, provides Active Pharmaceutical Ingredients (APIs), intermediates, and custom synthesis services aligned with customer timelines and bud...
Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
About the Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Derivatives (Caffeine, e...
Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.
About the Company : Bhavna Laboratories Pvt. Ltd., founded in 1986, is an Indian manufacturer of APIs and intermediates. The company is approved by the FDA of India and holds cGMP certification for it...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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DOSAGE - OINTMENT;OPHTHALMIC - 0.5%
USFDA APPLICATION NUMBER - 200738
DOSAGE - GEL;OPHTHALMIC - 0.38%
USFDA APPLICATION NUMBER - 208219
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ABOUT THIS PAGE
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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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Loteprednol Etabonate manufacturer or Loteprednol Etabonate supplier.
A Lotemax (TN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lotemax (TN), including repackagers and relabelers. The FDA regulates Lotemax (TN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lotemax (TN) 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 Lotemax (TN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Lotemax (TN) supplier is an individual or a company that provides Lotemax (TN) active pharmaceutical ingredient (API) or Lotemax (TN) finished formulations upon request. The Lotemax (TN) suppliers may include Lotemax (TN) API manufacturers, exporters, distributors and traders.
click here to find a list of Lotemax (TN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Lotemax (TN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Lotemax (TN) active pharmaceutical ingredient (API) in detail. Different forms of Lotemax (TN) DMFs exist exist since differing nations have different regulations, such as Lotemax (TN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lotemax (TN) DMF submitted to regulatory agencies in the US is known as a USDMF. Lotemax (TN) USDMF includes data on Lotemax (TN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lotemax (TN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lotemax (TN) suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Lotemax (TN) Drug Master File in Korea (Lotemax (TN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lotemax (TN). The MFDS reviews the Lotemax (TN) KDMF as part of the drug registration process and uses the information provided in the Lotemax (TN) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lotemax (TN) KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Lotemax (TN) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lotemax (TN) suppliers with KDMF on PharmaCompass.
A Lotemax (TN) written confirmation (Lotemax (TN) WC) is an official document issued by a regulatory agency to a Lotemax (TN) manufacturer, verifying that the manufacturing facility of a Lotemax (TN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lotemax (TN) APIs or Lotemax (TN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Lotemax (TN) WC (written confirmation) as part of the regulatory process.
click here to find a list of Lotemax (TN) suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Lotemax (TN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lotemax (TN) API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Lotemax (TN) as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Lotemax (TN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lotemax (TN) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lotemax (TN) suppliers with NDC on PharmaCompass.
Lotemax (TN) Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Lotemax (TN) GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Lotemax (TN) GMP manufacturer or Lotemax (TN) GMP API supplier for your needs.
A Lotemax (TN) CoA (Certificate of Analysis) is a formal document that attests to Lotemax (TN)'s compliance with Lotemax (TN) specifications and serves as a tool for batch-level quality control.
Lotemax (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Lotemax (TN) CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Lotemax (TN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Lotemax (TN) EP), Lotemax (TN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lotemax (TN) USP).
