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List of Drug Master Files (DMF) of Isotretinoin Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Biophore India Pharmaceuticals Pvt Ltd (1)

02 RANBAXY LABORATORIES LIMITED (1)

03 Sun Pharmaceutical Industries Limited (1)

04 BASF (1)

05 Catalent Pharma Solutions (1)

06 Chongqing Huapont Pharmaceutical (2)

07 EASTMAN KODAK (1)

08 Helsinn Advanced Synthesis (1)

09 Hetero Drugs (1)

10 Ipca Laboratories (1)

11 JIANGXI HENGXIANG PHARMACEUTICAL TECHNOLOGY CO LTD (1)

12 Olon S.p.A (1)

13 RP SCHERER GMBH & CO. KG (1)

14 Siegfried AG (1)

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01 13-CIS-RETINOIC ACID (ISOTRETINOIN) (1)

02 13-Cis-RETINOIC ACID (ISOTRETINOIN) (1)

03 9-Z-ISOTRETINOIN (1)

04 ACCUTANE (10MG, 40MG) (1)

05 ACCUTANE (ISOTRETINOIN) (1)

06 ISOTRETINOIN (6)

07 ISOTRETINOIN (NON-STERILE BULK FORM) (1)

08 ISOTRETINOIN USP (2)

09 ISOTRETINOIN USP (NON-STERILE BULK) (1)

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01 China (3)

02 Germany (2)

03 India (5)

04 Italy (1)

05 Switzerland (2)

06 U.S.A (2)

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01 Active (9)

02 Inactive (6)

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01 Complete (7)

02 Blank (8)

URL Supplier Web Content
15169
Inactive
2000-11-29
N/A
II
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32517
Active
2018-08-31
Complete
2018-10-31
2018-03-19
II
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URL Supplier Web Content
34510
Active
2020-02-12
N/A
II
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21653
Active
2008-05-23
Complete
2017-09-28
2016-09-30
II
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URL Supplier Web Content
19918
Active
2006-10-30
Complete
2013-05-09
2012-12-14
II
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URL Supplier Web Content
36857
Active
2022-03-22
Complete
2022-04-18
2022-03-15
II
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19191
Active
2005-10-25
N/A
II
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7485
Active
1988-05-16
Complete
2013-01-14
2012-12-10
II
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4676
Active
1982-09-27
Complete
2014-06-23
2013-08-09
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Looking for 4759-48-2 / Isotretinoin API manufacturers, exporters & distributors?

Isotretinoin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Isotretinoin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Isotretinoin manufacturer or Isotretinoin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Isotretinoin manufacturer or Isotretinoin supplier.

PharmaCompass also assists you with knowing the Isotretinoin API Price utilized in the formulation of products. Isotretinoin API Price is not always fixed or binding as the Isotretinoin Price is obtained through a variety of data sources. The Isotretinoin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Isotretinoin

Synonyms

4759-48-2, 13-cis-retinoic acid, Accutane, Roaccutane, Claravis, Neovitamin a acid

Cas Number

4759-48-2

Unique Ingredient Identifier (UNII)

EH28UP18IF

About Isotretinoin

A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.

Isotretinoin Manufacturers

A Isotretinoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isotretinoin, including repackagers and relabelers. The FDA regulates Isotretinoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isotretinoin 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 Isotretinoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Isotretinoin Suppliers

A Isotretinoin supplier is an individual or a company that provides Isotretinoin active pharmaceutical ingredient (API) or Isotretinoin finished formulations upon request. The Isotretinoin suppliers may include Isotretinoin API manufacturers, exporters, distributors and traders.

click here to find a list of Isotretinoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Isotretinoin USDMF

A Isotretinoin DMF (Drug Master File) is a document detailing the whole manufacturing process of Isotretinoin active pharmaceutical ingredient (API) in detail. Different forms of Isotretinoin DMFs exist exist since differing nations have different regulations, such as Isotretinoin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Isotretinoin DMF submitted to regulatory agencies in the US is known as a USDMF. Isotretinoin USDMF includes data on Isotretinoin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isotretinoin USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Isotretinoin suppliers with USDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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