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01 1Siegfried AG

02 1Biophore India Pharmaceuticals Pvt Ltd

03 1BASF

04 1Catalent Pharma Solutions

05 2Chongqing Huapont Pharmaceutical

06 1EASTMAN KODAK

07 1Helsinn Advanced Synthesis

08 1Hetero Drugs

09 1Ipca Laboratories

10 1JIANGXI HENGXIANG PHARMACEUTICAL TECHNOLOGY CO LTD

11 1Olon S.p.A

12 1RP SCHERER GMBH & CO. KG

13 2Sun Pharmaceutical Industries Limited

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSiegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-23

Pay. Date : 2013-08-09

DMF Number : 4676

Submission : 1982-09-27

Status : Active

Type : II

Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

GDUFA

DMF Review : Complete

Rev. Date : 2014-05-13

Pay. Date : 2013-09-25

DMF Number : 27484

Submission : 2013-09-27

Status : Active

Type : II

Biophore

03

AACR Annual meeting
Not Confirmed

06

AACR Annual meeting
Not Confirmed

07

AACR Annual meeting
Not Confirmed

09

AACR Annual meeting
Not Confirmed

09

AACR Annual meeting
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2013-01-14

Pay. Date : 2012-12-10

DMF Number : 7485

Submission : 1988-05-16

Status : Active

Type : II

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10

AACR Annual meeting
Not Confirmed

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

Isotretinoin manufacturers, exporters & distributors 1

63

PharmaCompass offers a list of Isotretinoin 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 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.

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.

Claravis Manufacturers

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

Claravis Suppliers

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

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

Claravis USDMF

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

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

click here to find a list of Claravis 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.