"The value of a generics company is really about the portfolio. Early on, we focused on products that weren't too complex. We've since expanded into modified releases, niche API and very challenging formulas. Plus, our approval success rate has been outstanding."
Chintu Patel
CEO

Featured Products


  • Buprenorphine and Naloxone Sublingual Tablets

A Consumer's Guide to Generic Drugs


What Does THAT Mean?



Regulatory

Amneal prides itself on its pioneering achievements and impressive regulatory track record.

Our Regulatory Affairs (RA) department is responsible for preparing and submitting product applications to the US Food & Drug Administration (FDA). This group communicates with the FDA to ensure that our products satisfy the necessary-and demanding-approval process before they reach the healthcare marketplace.

Equipped with the eCTD / QbR / QOS format and software, our RA team has rapidly expedited ANDA approvals with the FDA. As one of the first few companies to file an ANDA via this new reformatted, innovative application process submitted electronically, Amneal saw its first "eCTD approval" secured in just ten months and ten days. Considering approvals typically take 18-24 months using the traditional hard-copy method, this is truly a breakthrough accomplishment. (For details on the U.S. FDA electronic application process, visit http://www.fda.gov/cder/regulatory/ersr/ectd.htm.)

Regulatory Affairs also ensures continued, post-approval product compliance by maintaining FDA cGMP in all facilities. Thanks to its RA team, Amneal has long celebrated an enviable cGMP inspection reputation. For all of us here at Amneal, compliance is not just a requirement of doing business in the United States; it is an extension of our infatuation with quality and our endless quest for excellence. In fact, we often press FDA inspectors for ideas on ways we can further improve our already-superb operations.

DEA Regulation & Compliance

Amneal Pharmaceuticals holds DEA licenses for all controlled substances (Schedules CII–CV). With this authorization we are approved for all aspects of producing and marketing controlled substances under DEA regulation. This includes acquiring API, dosing, filling, cage storage, vault storage, Form 222 processing, manufacturing, distribution and data management / tracking.

Securing and maintaining our DEA license is yet one more responsibility assumed by the RA group–specifically, by an extensively experienced four-member team completely dedicated to absolute DEA compliance. This team is fully responsible and accountable for both controlled substance security and DEA compliance, meticulously maintaining ARCOS filing, carefully processing 222 forms and strictly monitoring picking, packing and shipping, in person.

Our expansive controlled substances cage and vault comfortably accommodate ready supply of both API and finished goods. We never experience volume issues due to limited storage space. Approval is granted by facility, with Branchburg holding a CI–V license and all other plants approved for CII–V. The Glasgow, KY distribution center is authorized to handle CIII–V products.

Generic Drug Approval Process

Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical and clinical data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). For complete details on the process Amneal follows for product approvals, visit the FDA website.