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List of all Manufacturers, Suppliers & Exporters of Isotretinoin API listed on PharmaCompass with details of regulatory filings

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01 Biophore India Pharmaceuticals Pvt Ltd (1)

02 LGM Pharma (1)

03 RANBAXY LABORATORIES LIMITED (1)

04 Sun Pharmaceutical Industries Limited (2)

05 R L Fine Chem (1)

06 AASraw Biochemical Technology Co., Ltd (1)

07 Asia Pioneer Pharmaceuticals (1)

08 BASF (1)

09 Catalent Pharma Solutions (1)

10 Chongqing Huapont Pharmaceutical (2)

11 EASTMAN KODAK (1)

12 F. Hoffmann-La Roche (1)

13 Hangzhou Deli Chemical (1)

14 Helsinn Advanced Synthesis (1)

15 Hetero Drugs (1)

16 Ipca Laboratories (1)

17 JIANGXI HENGXIANG PHARMACEUTICAL TECHNOLOGY CO LTD (1)

18 Kimia Biosciences (1)

19 Nishchem International Pvt. Ltd (1)

20 Olon S.p.A (1)

21 Qingdao Qingmei Biotech (1)

22 RP SCHERER GMBH & CO. KG (1)

23 SAMEX OVERSEAS (1)

24 Shanghai New Hualian Pharmaceutical (1)

25 Siegfried AG (1)

26 Sionc Pharmaceuticals (1)

27 Srikem Laboratories Pvt. Ltd (1)

28 Unipex (1)

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01 China (7)

02 France (1)

03 Germany (2)

04 India (12)

05 Italy (1)

06 Switzerland (3)

07 U.S.A (4)

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01 Active (9)

02 Inactive (6)

03 Blank (15)

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01 Valid (7)

02 Withdrawn by Holder (2)

03 Blank (21)

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01 Blank (30)

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01 WC-0011 (1)

02 WC-0159 (1)

03 Blank (28)

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USDMF

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CEP/COS

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Application Number
27484
Status
Active
Fees Paid
Reviewed
 
Filing Details
ISOTRETINOIN
Issue/Submission Date
2013-09-27
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USDMF

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Application Number
15169
Status
Inactive
Fees Paid
N/A
 
Filing Details
ISOTRETINOIN USP (NON-STERILE BULK)
Issue/Submission Date
2000-11-29
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USDMF

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CEP/COS

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Written Confirmation

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Application Number
32517
R1-CEP 2002-011 - Rev 06
Indian CDSCO WC-0159
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-25
Filing Details
ISOTRETINOIN USP
Isotretinoin
Isotretinoin (USP/EP/BP)
Issue/Submission Date
2018-08-31
2023-05-25
2022-06-08
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USDMF

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Application Number
Indian CDSCO WC-0011
Status
 
Valid
2025-06-02
Filing Details
Isotretinoin (USP/Ph.Eur.)
Issue/Submission Date
2022-06-08
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USDMF

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USDMF

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Application Number
19191
Status
Active
Fees Unpaid
N/A
 
Filing Details
ISOTRETINOIN (NON-STERILE BULK FORM...
Issue/Submission Date
2005-10-25
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USDMF

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Application Number
4887
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
13-Cis-RETINOIC ACID (ISOTRETINOIN)
Issue/Submission Date
1983-03-23
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USDMF

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Application Number
14493
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
ACCUTANE (ISOTRETINOIN)
Issue/Submission Date
1999-10-14
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USDMF

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Application Number
13071
Status
Inactive
Fees Paid
N/A
 
Filing Details
9-Z-ISOTRETINOIN
Issue/Submission Date
1998-07-01
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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.

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.

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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