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01 1Biophore India Pharmaceuticals Pvt Ltd

02 1BASF

03 1Catalent Pharma Solutions

04 2Chongqing Huapont Pharmaceutical

05 1EASTMAN KODAK

06 1Helsinn Advanced Synthesis

07 1Hetero Drugs

08 1Ipca Laboratories

09 1JIANGXI HENGXIANG PHARMACEUTICAL TECHNOLOGY CO LTD

10 1Olon S.p.A

11 1RP SCHERER GMBH & CO. KG

12 1Siegfried AG

13 2Sun Pharmaceutical Industries Limited

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PharmaCompass

01

  • 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

06

Cophex
Not Confirmed

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.

Roacutan Manufacturers

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

Roacutan Suppliers

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

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

Roacutan USDMF

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

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

click here to find a list of Roacutan 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.