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Product and Manufacture

上市日期: 2017-01-04
Product Details

1)Manufacturing Capabilities

Chongqing RuiZhe Pharmaceutical Co., Ltd. (hereinafter referred to RuiZhe Pharmaceutical), wasfounded in Changshou District, Chongqing in 2012. As CPRI’s pilot scale-up manufacturing site, it is also well known for being one of new drug industrialization andincubation base in Chongqing. Ruizhe has been mostly engaged in process development activities for high-tec,high value-added API and advanced intermediates by adopting a patent designing-around strategy to support manufacturing process development enabling our customer to file an ANDA application with PIV certification. Key products had been regulatory approved by US FDA, CFDA, EDQM, Korea FDA, Japan PMDA andAustralia TGA, 80% of which exported overseas to US/EU market.

 

Ruizhe had been constructed in compliance with international advanced norm:

 

1.Multi-functionalized industrialization test platform in accordance with the requirements of cGMP;

2. FDA and CFDA approved high potency Anti-tumor API production workshop with a sound market prospect owing to an intellectual property right developed solely by CPRI.

3. FDA and CFDA approved Iron deficiency API production workshop with a sound market prospect owing to an intellectual property right developed solely by CPRI.

4. GMP-like workshop for high potent and cytotoxic API production.

5. Advanced intermediate production workshop

  

CPRI managed to create a modernized, normalized and international standard complying pilot and full scale production workshop by combining multi-function industrialization test platform and a leveling up R&D system to provide a full range and reliable CMO services to our clients worldwide.

 

RuiZhe Pharmaceutical will bring out high-effective, safety product on the basis of improved facility and technology continuously and strong R&D system in CPRI to develop international market in further, and lay the solid foundation forRuiZhe to build-up a high-tech, international, development-oriented new drugindustrialization incubation platform and base.

 

 

  2)原料药


Product Name

CAS No

Indication

Remarks

API

1

Iron sucrose*

8047-67-4

Anaemia

DMF No.: 18390

2

Canagliflozin*

928672-86-0

Diabetes

DMF No.: 30853

3

Pemetrexed disodium*

150399-23-8

Cancer

DMF No.: 22141

4

Abiraterone acetate*

154229-18-2

Cancer

DMF No.: 26779

5

Carfilzomib*

868540-17-4

Cancer

DMF No.: 030162

6

Bortezomib*

179324-69-7

Cancer

DMF to be filed

7

Ferric carboxymaltose*

9007-72-1

Anaemia

DMF to be filed

8

Dabigatran etexilate mesylate*

593282-20-3

Thrombosis

DMF to be filed

9

Aripiprazole*

129722-12-9

Schizophrenia

China GMP certified

10

Dutasteride*

164656-23-9

Prostate hyperplasia

China Registration filed

11

Ferric Citrate

2338-05-8

hyperphosphatemia

Pilot batch

12

Apremilast*

608141-41-9

Psoriasis

Pilot batch

13

Dasatinib*

302962-49-8

Cancer

Lab scale

14

Aripiprazole Lauroxil*

1259305-29-7

Schizophrenia

Lab scale

 

  3)中间体

Intermediates

1

Rocuronium intermediates

119302-20-4, 50588-22-2

Commercial

2

3-quinuclidinone hydrochloride

1193-65-3

Commercial


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