API Registration

Consulting and Regulatory Services

Over the years, we have undertaken several registration. Working closely, we have a strong understanding of the requirements and process in India for NOC, clinical trials and other conditions required to ensure a successful entry into India with the correct licenses & Requirements . We provide the following services for Registration:- 1) Consultancy on end to end registration. Filing on Behalf of our principles. 2) Consultancy on end to end registration and marketing, working as an extended arm of our principles for the Indian and other markets.

Ruskin Chemipharm is a Mumbai based independent consulting professional company run by experts who specialize in providing consulting services on all DCGI related issues. We provide regulatory services to the Indian & International Pharmaceutical Industry for.

New Drug Approval

Formulation Registration

API Registration

We Specialize in helping our customers
to obtain the following:

API Registration

Requirement:

Dossier as per DCGI Guidelines.

Time Taken :

8 to 12 months

Registered Products With DCGI

Sr. No. Products Name Manufacturer
Sr. No. Products Available Manufacturer
1 Amphotericin B I.P NCPC
2 Arbekacin Sulphate J.P Reyon Pharmaceutical Co. Ltd.
3 Atracurium Besylate BP Jiangsu Hengrui Medicine Co. Ltd
4 Benzathine Benzylpenicillin (Bulk Sterile)IP CSPC Zhongnuo Pharmaceutical Co. Ltd
5 Benzylpenicillin Sodium( Bulk Sterile)IP CSPC Zhongnuo Pharmaceutical Co. Ltd
6 Capreomycin BP NCPC
7 Caspofungin Acetate (Under Registration) Jiangsu Hengrui Medicine Co. Ltd
8 Ceftriaxone Sodium (Non-Sterile) Reyoung Pharmaceutical Co. Ltd.
9 CisAtracurium Besylate BP Jiangsu Hengrui Medicine Co. Ltd
10 Clotrimazole Shandong Boshan Pharmaceutical
11 Dexmeditomidine HCL USP Jiangsu Hengrui Medicine Co. Ltd
12 Doxycycline Hyclate (Under Registration) Kunchan Chemicals
13 Etoposide IP Jiangsu Hengrui Medicine Co. Ltd
14 Levamisole Guilin Pharmaceutical
15 Mefenamic Acid IP Shanxi Baoxin Pharmaceutical Co. Ltd
16 Mesna EP Jiangsu Hengrui Medicine Co. Ltd
17 Mitomycin Wuxi Fortune Pharmaceutical Co. Ltd.
18 Oxaliplatin BP Jiangsu Hengrui Medicine Co. Ltd
19 Piracetam IP Jiangxi Yuehua Pharmaceutical Co. Ltd
20 Procaine Benzylpenicillin (Bulk Sterile)IP CSPC Zhongnuo Pharmaceutical Co. Ltd
21 Rifampicin IP Shenyang Antibiotic Manufacturer
22 Sevoflurane & Desflurane Formulation Shanghai Hengrui
23 Sevoflurane USP Jiangsu Hengrui Medicine Co. Ltd
24 Streptomycin Sterile IP NCPC
25 Sulbactam Sodium Sterile Jiangxi Dongfeng Pharmaceutical Co. Ltd
26 Tacrolimus NCPC
27 Teicoplanin IP Dongkook Pharmaceutical Co. Ltd

Category Fee

Factory Registration $10000

Factory Inspection ( if demanded by DCGI) $25000

New Drug Application $3500

Product Registration $5000 per product

Scope Of The Work

Registration

Krishnakumar Iyer

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