A government-funded research organization in India is looking for Contract Manufacturers for the synthesis of one of their compounds for IND filing and permission for the phase-1 clinical trial. The API is a small molecule (heterocyclic compound). Timeline : 2 - 3 months | Quantity 3 kg.

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meera@svakls.com

We can help you out regarding this. Please contact us.

18:48,  12 Dec 2018
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vijaya.nuty@gvkbio.com

We offer long term Contract Manufacturing services right from strategic partnerships in development, validations, DMF filing and commercial manufacturing of NCE’s, Active Pharmaceutical Ingredients (APIs)/advanced intermediates to APIs. We have flexible business models to support various client needs:
A. Technology/Process development and technology transfer to customer (Contract development model)
B. Technology absorption from customer, validations, DMF filing support and Commercial manufacturing (Contract manufacturing model)
C. Technology development and validations, DMF filing support commercial manufacturing (Contract development and manufacturing model)
Our manufacturing facility has approvals from worldwide regulatory authorities like below and these accreditations facilitate faster and easier approvals of DMFs/dossiers for our business partners.
a) In rare instance a joint audit was performed by auditors from USFDA, EDQM and Spanish MOH in 2013.
b) We are approved by PMDA (Pharmaceutical and Medical Devices Agency) Japan in 2012 and supplying commercially to customers in Japan including Pfizer Japan.
c) FDA Korea approved us in 2012, we have our presence for a decade in Korea market and we serve to almost 8-9 OEMs.
d) USFDA in 2015 & 2018 (Received EIR)

09:48,  20 Dec 2018
Reply

vijaya.nuty@gvkbio.com

We offer long term Contract Manufacturing services right from strategic partnerships in development, validations, DMF filing and commercial manufacturing of NCE’s, Active Pharmaceutical Ingredients (APIs)/advanced intermediates to APIs. We have flexible business models to support various client needs:
A. Technology/Process development and technology transfer to customer (Contract development model)
B. Technology absorption from customer, validations, DMF filing support and Commercial manufacturing (Contract manufacturing model)
C. Technology development and validations, DMF filing support commercial manufacturing (Contract development and manufacturing model)
Our manufacturing facility has approvals from worldwide regulatory authorities like below and these accreditations facilitate faster and easier approvals of DMFs/dossiers for our business partners.
a) In rare instance a joint audit was performed by auditors from USFDA, EDQM and Spanish MOH in 2013.
b) We are approved by PMDA (Pharmaceutical and Medical Devices Agency) Japan in 2012 and supplying commercially to customers in Japan including Pfizer Japan.
c) FDA Korea approved us in 2012, we have our presence for a decade in Korea market and we serve to almost 8-9 OEMs.
d) USFDA in 2015 & 2018 (Received EIR)

09:48,  20 Dec 2018
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tqli@cqpharm.com

our business if focusing on the CMO business ,looks like we are a good cooperatror.

09:05,  26 Dec 2018
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ankita.barve@piramal.com

I would be interested in discussing this inquiry further.We could definitely of help in providing our GMP manufacturing services from our USFDA / EMA approved plant for your Phase II molecule.

18:05,  06 Mar 2019
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chris@langhuapharma.com

Dear Sir or Madam,

We are USFDA/EDQM/WHO/CFDA/PMDA approved CDMO in China. With more than 15 years experience, we are supplying 5 intermeidates for current blockbuster drugs. We are interesting in your project and would like to contact to know more details.

13:00,  11 Mar 2019
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