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State of California—Health and Human Services Agency	California Department of Public Health
	Food and Drug Branch

NEW DRUG MANUFACTURING LICENSE APPLICATION

PLEASE COMPLETE THIS FORM FULLY—INCOMPLETE APPLICATIONS WILL BE RETURNED

See Page 2 for Instructions

NEW APPLICANT

RELOCATION

OWNERSHIP CHANGE

OWNERSHIP AND LOCATION CHANGE

1.	Legal Name of Firm						9.	Facility Operator (name and title)

2.	DBA (List additional DBAs on separate sheet if necessary.)						10.	Facility Telephone Number			11.	Facility FAX Number
								(	)			(	)

3.	Facility Address (number, street)						12.	24-Hour Emergency Telephone Number			13.	E-Mail Address
								(	)
4.	Facility Address (continued)						14.	Correspondent (name and title)

5.	City		State		ZIP Code		15.	Correspondent Telephone Number			16.	Correspondent FAX Number
								(	)			(	)

6.	Mailing Address (if different or P.O. Box number)						17.	Country (if other than United States)

7.	Mailing Address (continued)						18.	Website (URL)

8.	City		State		ZIP Code		19.	Interstate Commerce
									Product Shipped	Product or Raw Materials Received				N/A

20.	Type of Ownership:	Individual/Sole Proprietorship		Partnership		Corporation/Limited Liability Company				Nonprofit	Other:
						(attach copy of Partnership agreement or Articles of Incorporation)

21.	Corporate Name (if applicable)						State of Incorporation

22. Owners’ or Officers’ Names and Titles

Owners’ or Officers’ Names and Titles (Attach separate sheet if necessary)


23. Size of Facility (square feet):________________
Business days and hours:____________________	Business License Number:_____________	Seller’s Permit:________________
Number of Employees at this Facility:____________________	Federal Employee Identification Number:__________________
24. Stage of Manufacture at Date of Application (check all that apply)

Manufacturing products

Validation – Completion Date: _______________________

Plant construction/design (Targeted Completion Date: ____________________)

Other (specify): ____________________________________________________

25. Intended Drug Destination (check all that apply)

Commercial distribution

Human clinical trials (investigational use)

California distribution only

U.S. distribution

Export market

26. Type of Drug Product (check all that apply)

Prescription*

Over-the-counter

	*If Prescription or Both is checked complete the Disclosure Statement form (CDPH53)
Both*	refer to PDMA requirements on instruction page 2.

27. Drug Products Manufactured at this Location (check all that apply)

700 Bulk pharmaceuticals (API)

708 Biologics

701 Medical gases

702Radioactive

703Veterinary

704Controlled substances (schedule: _______________DEA#:_____________(attach copy of DEA certificate)

712Topical

705	Approved New Drug	709 Parenteral		Other (specify):
706	Investigational New Drugs (IND)	710	Oral Dose (solid/liquid)	__________________
707	Biotech	711	Pre-IND

28.Manufacturing processes/activities employed or planned in the manufacture of the drugs listed above. Indicate if these processes/activities will be done at this location (in-house) or by a contract. List other processes using additional sheets, if necessary. (Check at least one or more.)

Processes/Activities	In-house	Contract	Processes/Activities	In-house Contract
Aerosolization			Powder Mixing
Aseptic			Relabel Only
Coating			Repackage Only
Emulsification			Sterilization
Encapsulation			Suspension
Fermentation/tissue culture viral			Tableting
vector/gene therapy			Other (Specify):__________________
Liquid Mixing

29. Payment Code

A—$1600 (Fee is Non-Refundable)

MAKE CHECKS PAYABLE TO: CA DEPT. OF PUBLIC HEALTH

See page 2 for mailing address

30. License Fees Due:	Enter Each Fee Below:
a. License Fee (see #30)	$

b. PDMA* ($100 If Applicable – see page 2)	$
c. Total Payment Due	$

The Food and Drug Branch MUST BE NOTIFIED of any change in the application information as provided by CA Health and Safety Code, §111630. By signature, I declare under penalty of perjury that all information provided herein is true and correct.

31. Signature

Printed Name

Title

Date

PLEASE DO NOT WRITE BELOW THIS LINE.

License Number

Expiration Date

Date Received

Payment Type

Amount

CDPH 52N (06/09)

Fund 3018 Index 5623 PCA 76213 Receipt Source 125700 Agency Source 44

Page 1 of 2

NEW DRUG MANUFACTURING LICENSE APPLICATION INSTRUCTIONS

A separate application is required for each place of business. Please complete and/or amend this application as is most appropriate to your facility. Include the appropriate fee for each application and make payable to: CA DEPARTMENT OF PUBLIC HEALTH. The fee must accompany this application or it cannot be processed. Unsigned or incomplete applications cannot be processed. The following are further instructions on how to complete this application:

New Applicant: Place an (X) in the box next to New Applicant if your firm has not previously applied for a Drug Manufacturing License at this location while under the current ownership. This license is non-transferable. If your firm has changed location, ownership, or both, place an (X) in the appropriate box and also in the box next to New Applicant. For any section that does not apply to your company, please indicate with (N/A). Do not leave any sections blank.

1.Name of Firm: Enter full name of business, corporation, company, or organization applying for licensure.

2.DBA: Enter any other name(s) your company is doing business as.

3.–5. Facility Address: Enter the number, street, city, state, and ZIP code for this facility location.

6.–8. Mailing Address: Enter the full mailing address if different from the facility address or P.O Box.

9.	Facility Operator: Enter the full name(s) of the person(s) in charge of drug manufacturing at this facility and their title(s).
10.	Facility Telephone Number: Enter daytime business telephone number of this facility.
11.	Facility FAX Number: Enter facility FAX number.
12.	24-Hour Emergency Telephone Number: Enter telephone number to be called in the event of an emergency.
13.	E-mail Address: Enter facility e-mail address.
14.	Correspondent: Enter the name of the person to contact for information regarding this application and their title.
15.	Correspondent Telephone Number: Enter the daytime business telephone number of the contact person.
16.	Correspondent FAX Number: Enter the daytime business FAX number of the contact person.
17.	Country: Enter the country where your facility is located, if outside of the United States.
18.	Website: Enter the website address for your business, if applicable.
19.	Interstate Commerce: Place an (X) in all appropriate boxes that correctly describe your business’ receipt or distribution of products or materials
	through or into interstate commerce.
20.	Type of Ownership: Place an (X) in the box next to the appropriate legal description of the facility’s ownership.
21.	Corporate Name: Enter corporate name if applicable. Enter state of incorporation if applicable. (Attach copy)
22.	Owners’ or Officers’ Names: List the business owners’ or officers’ names and titles. USE ADDITIONAL SHEETS IF NECESSARY.
23.	Size of Facility: Indicate the approximate size (in square feet) of the facility and the approximate number of employees at the facility and list
	business days and hours. Enter the Business license, FEIN, and Seller’s Permit and provide required copies.
24.	Stage of Manufacture: Place an (X) in the box next to the stage of manufacture your products are in at the time of application submission. Check
	all that apply.
25.	Intended Drug Destination: Place an (X) in the box adjacent to the destination(s) for your manufactured products. Check all that apply.
26.	Types of Products: Place an (X) in each box that applies to each type of drugs manufactured or to be manufactured. For human prescription (Rx)
	drug manufacturers, refer to PDMA requirements below*.
27.	Products Manufactured: Place an (X) in the box adjacent to each product area that applies to the drugs manufactured or to be manufactured. Use
	additional sheets if necessary. (attach copy of DEA certificate)
28.	Manufacturing Processes: Place an (X) in the columns adjacent to all applicable processes to be performed in-house and/or contracted out.
	Leave line blank if the indicated process will not be applied to the manufacturing of listed drugs. List additional processes or methods as needed
	herein or on additional sheets if necessary.
29.	Payment Fee Code: Your license fee is based on the application type **.

	Application Type	Fee		Payment Interval	Payment Code

	New, Relocation, or Ownership Change	$1600	First License only		A

	* PDMA (Prescription Drug Marketing Act) Requirements:			If your firm manufactures human prescription (Rx) drugs, an
	additional $100 must be added to the license fee and a Disclosure Statement (Form CDPH 53) must be submitted for each person
	listed on lines #9 and #23 (instructions provided therein). Information relevant to the PDMA, (e.g., Disclosure Statements and
	Applicant Fingerprint Live Scan requirements) can be reviewed at: http://www.cdph.ca.gov/fdb/HTML/Drug/PDMA.htm.
**	LICENSE FEES ARE NON-REFUNDABLE AND NON-TRANSFERABLE TO OTHER LOCATIONS OR ENTITIES
30.	License Fee Due: Enter appropriate fees due.
	a. Enter license fee according to payment codes in #30. (License valid for 1 year.)
	b. Add $100 PDMA fee if it applies to your firm. See PDMA requirements above*.
	c. Enter Total Payment Due by adding ”A” and “B”
31.	Sign the application, print your name, print your title, and enter the date. All signatures must be original.
	Make checks payable to: CA DEPARTMENT OF PUBLIC HEALTH			Mail Application and Check to:
Regular Mail: California Department of Public Health			Overnight Mail: California Department of Public Health
	Food and Drug Branch - Cashier			Food and Drug Branch - Cashier
	MS 7602			1500 Capitol Avenue, MS-7602
	P.O. Box 997435			Sacramento, CA 95814
	Sacramento, CA 95899-7435

If you have any questions about this application, please contact the FDB License Desk for Drug Manufacturing at (916) 650-6500, or visit our website at: http://www.cdph.ca.gov/programs/Pages/FDB.aspx.

CDPH 52N (06/09)

Fund 3018 Index 5623 PCA 76213 Receipt Source 125700 Agency Source 44

Page 2 of 2

Question	Answer
Form Name	Form Cdph 52N
Form Length	2 pages
Fillable?	No
Fillable fields	0
Avg. time to fill out	30 sec
Other names	24-Hour, PDMA, 52N, Rx

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