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APIs (HUMAN & VET)
BULK DRUGS
DRUG INTERMEDIATES
PELLETS
AGRO CHEMICALS
REGULATORY AFFAIRS
Services
Sourcing:
We source API s (Vet & Human), Pellets, DC grades, Drug Intermediates, Food & Feed, Agro chemicals from India and China. Our services include identification of competitive producers meeting the requirements of cGMP, Regulatory Affairs (DMF, EU-DMF, USFDA, JP-DMF, CEP), Product specifications (Pharmacopoeial standard and additional specs like particle size, bulk density, microbial etc.), the mediation of sales and purchases at correct market conditions, Assistance and intervention for both parties if any problem arise.
• It identifies right quality makers
• It meets customer’s demand and can cater their all immediate and future requirements
• It ensures Transparency, Reliability, Availability and Accountability
• Price negotiation with suppliers
• It constantly follows up for shipment

Contract manufacturing:
We have close relationship with many Indian pharmaceutical producers (API and Finished dosages) who have capability to undertake contract manufacturing under secrecy agreement. Those units which are well equipped with QC/QA, R&D, Regulatory etc can undertake number of process reactions.

Many business people focus on what they do best and leaving the rest to others. Here role of contract manufacturers come into picture. Our contract manufacturers offer numerous advantages over in-house manufacturing, including lower costs, flexibility, access to external expertise and reduced capital.
On getting your enquiries, we will provide details of contract manufacturers.

Regulatory services:-
Pharma Ocean’s associate can offer following services:-
  - Preparation of DMFs for all Ministries including Japanese Health Ministry (PMDA), USFDA etc..
  - Foreign Manufacturer Accreditation with PMDA, Japan
  - Third party audits on behalf of Foreign customers

Synthesis:-
Pharma Ocean’s associate can offer following services:-

  - Custom synthesis
  - Impurities
JAPANESE MARKET

The Japanese pharmaceutical market is the world’s second largest next to the US, with annual sales of more than 6 trillion yen. Sustainable growth and the future outlook in the pharmaceutical market in Japan will continue to be impacted by multiple trends, including: increasing patent expiry, expanding generic competitors, new drug launches focusing on unmet/underserved treatment needs; regulatory reforms including an improved drug approval process; pressures on pricing as budgets continue to be overstretched; increasing number of mid-sized Japanese Pharma companies seeking global opportunities to offset the potential loss of domestic market share. Encompassing all of these trends is a volume-driven market with drug usage and drug utilization expected to continue to increase and to contribute to overall positive growth.
Pharma Ocean makes bridge between Japanese partners and Indian partners in order to help both Indian producers to catch Japanese market and Japanese customers to have quality products with competitive price.
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