loader
Please Wait
Applying Filters...

Seqens Seqens

X

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

Client Email Product
Menu
Filters Filter
Cross PopUp
FILTER :

filter

01 Biophore India Pharmaceuticals Pvt Ltd (1)

02 BASF (1)

03 Catalent Pharma Solutions (1)

04 Chongqing Huapont Pharmaceutical (2)

05 EASTMAN KODAK (1)

06 Helsinn Advanced Synthesis (1)

07 Hetero Drugs (1)

08 Ipca Laboratories (1)

09 JIANGXI HENGXIANG PHARMACEUTICAL TECHNOLOGY CO LTD (1)

10 Olon S.p.A (1)

11 RANBAXY LABORATORIES LIMITED (1)

12 RP SCHERER GMBH & CO. KG (1)

13 Siegfried AG (1)

14 Sun Pharmaceutical Industries Limited (1)

filter

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)

filter

01 China (3)

02 Germany (2)

03 India (5)

04 Italy (1)

05 Switzerland (2)

06 U.S.A (2)

filter

01 Active (9)

02 Inactive (6)

filter

01 Complete (7)

02 Blank (8)

URL Supplier Web Content
34510
Active
2020-02-12
N/A
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
21653
Active
2008-05-23
Complete
2017-09-28
2016-09-30
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
4887
Inactive
1983-03-23
N/A
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
19918
Active
2006-10-30
Complete
2013-05-09
2012-12-14
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
36857
Active
2022-03-22
Complete
2022-04-18
2022-03-15
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
19191
Active
2005-10-25
N/A
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
7485
Active
1988-05-16
Complete
2013-01-14
2012-12-10
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
4676
Active
1982-09-27
Complete
2014-06-23
2013-08-09
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
32517
Active
2018-08-31
Complete
2018-10-31
2018-03-19
II
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for 4759-48-2 / Isotretinoin API manufacturers, exporters & distributors?

Isotretinoin manufacturers, exporters & distributors 1

17

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.

Accutane Manufacturers

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

Accutane Suppliers

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

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

Accutane USDMF

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

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

click here to find a list of Accutane 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.
Post Enquiry
POST ENQUIRY