Regulatory Services
Key to chemwerth's success is our full range of regulatory services. Our close association with our represented manufacturers enables us to respond quickly and reliably to all aspects concerning regulatory submissions, 
cGMP issues, quality assurance issues and technical service requests. Our experience, knowledge, and good working relationship with the FDA help us to expedite regulatory approvals.
Within the past six years, chemwerth has completed in excess of 600 regulatory filings in more than 17 countries.
Our regulatory department continues to expand in both the US office and the Shanghai office. Our goal remains the same, to provide technical and regulatory expertise to our contract manufacturers and to provide the technical and regulatory support to our customers that help them get the speedy approval needed to maintain a competitive advantage.
Over 55 Approvals in the Past Six Years
| Injectable | Topical |
| Oral | Veterinarian |
2003 - 2007 Regulatory Approvals
| Anagrelide HCl | Lincomycin HCl (Injectable) |
| Amphotericin B | Lovastatin |
| Clindamycin PO4 | Metolazone |
| Dantrolene Na | Melengestrol Acetate |
| Esmolol HCl | Midodrine HCl |
| Fenoldopam Mesylate | Mitoxantrone HCl |
| Flecainide Acetate | Norepinephrine Bitartrate |
| Fosphenytoin Na | Pyridostigmine Br |
| Gemcitabine HCl | Sodium Tetradecyl Sulfate |
| Glimepiride | Tizanidine HCl |
| Griseofulvin | Vinorelbine Tartrate |
| Ivermectin |
2005 – 2007 Original DMF Regulatory Submissions
| Adapalene (US) | Ibutalide (US) |
| Amikacin Sulfate 1:1.8 (US, EU) | Ifosfamide (US, Can) |
| Amphotericin B (US, EU, Can) | Imiquimod (US) |
| Argatroban (US) | Irinotecan HCl (US) |
| Bivalirudin (US) | Iron Sucrose (US, Can) |
| Doxorubicin HCl (US) | Isradipine (US) |
| Esmolol HCl (US, Can, TGA) | Ketotifen Fumarate (US) |
| Epoprostenol (US) | Latanoprost (US) |
| Etomidate (US) | Ondansetron Base (US) |
| Fenoldopam Mesylate (US, EU) | Malathion (US) |
| Fomepizole (US) | Medroxyprogesterone Acetate (US) |
| Fosphenytoin Na (US, Can) | Nicardipine HCl (US) |
| Gemcitabine HCl (US, EU) | Nisoldipine (US) |
| Granisetron HCl (US, Can) | Ropivacaine HCl Monohydrate (US, EU) |
| Hydroxychloroquine Sulfate (US) | Tobramycin Form I (US, EU) |
Plus several exclusive and confidential products.
