No F.3-4/2022-Reg-I (M-321) Government of Pakistan Ministry of National Health Services, Regulation & Cor Drugs Regulatory Authority of Pakistan tion Islamabad, the 1O*yuty, 2023 FORM-6 it's. Weather Folds Pharmaceuticals, Plot No. 69/2, Phase-II Industrial Estate, ce Hattar (DML No,000644) SUBJECT: REGISTRATION OF DRUGS UNDER SECTION 7 OF THE DRUGS ACT, 1976 AND RULES 27, 2! 19 30_ OF THE DRUGS (LICEN: AND ADVERTISING) RULES, 1976, ‘The drug(s) as per details given below has/have been registétedssubject to the conditions appearing hereinafter. S.No. | Reg. No. | Name of Drug(s) & Composition Packing MRP ‘Approved | Shelf Life 1. | 116139 | Pratide Tablet Img 10s Rs369/- | Two Years Each film coated tablet contains: | Prucalopride as Succinate...........-1Mg | (As per *Innovator’s Specifications) e | 2 | 116140 | Prutide Tablet 2mg 10s Rs.595/- | ‘Two Years Each film coated tablet contains: | | Prucalopride as Succinate. 2mg | (As per *Innovator's Specifications) CONDITIONS:- (i) Manufacturer shall place first three production batches on real time stability studies throughout the proposed shelf life and on accelerated stability studies for six months, (ii) ‘The manufacturer shall perform validation of manufacturing process and method of analysis before sale of drug. ii) ‘The drug(s) shall be manufactured in compliance to the provision of Drugs Act, 1976 and rules framed there under. (iv) Every drug shall be produced in sufficient quantity so as to ensure its regular and adequate supply in the market (v) The manufacture of any drug shall not without the prior approval of the Registration Board, be discontinued for a period which may result in its shortage. (vi) The manufacturer shall follow information in label/patient information leaflet and medical literature regarding clinical use, route of administration, dosage, storage conditions of finished products and type of container closure system/packaging material in tine with the innovator brand or reference regulatory authorities or as approved by Registration Board. (vii) The manufacturer shall not use any of banned excipient moreover all excipients will be of pharmaceutical grade and within safe limits as defined by reference regulatory authorities. (viii) Colour Scheme of the labels / cartons & packaging material should not resemble with any of the drug(s) which has or have already been registered, (ix) One of the complete method of testing of the finished drug(s) (containing full details of minor and ‘major steps and protocols along with specifications, lower and upper limits) shall be submitted to the following institutions within a period of one mont > Chief, Drugs Control & Research Divisi (National Institute of M€alth, Islamabad, Cont'd P2y Director, Central Drug Laboratory, Building NO.4 (WFP), SMCHS, Block ~B, Karachi ~ 74400. Director, Drugs Testing Laboratory, Lahore, Faisalabad, Bahawalpur, Multan & Rawalpindi. tor, Drugs Testing Laboratory, Mirpur Azad Jammu Kashmir. Director, Drugs Testing Laboratory, Gilgit Baltistan. Director, Drugs Testing Laboratory, Sindh, Karachi. Director, Drugs Testing Laboratory, Khyber Pukhtunkhwa, Peshawar. > Director, Drugs Testing Laboratory, Balochistan, Brewery Road, Quetta (x) One copy of the master formula (of all registered drugs) containing the names of active and inactive materials (s) along with the quantities shall be furnished to the Assistant Director concerned within ‘a period of one month for which a receipt shall also be obtained (xi) The import of raw materials will be made at competitive rates in accordance with the Import Trade Control Order. (xii) The name shall be changed in case it has resemblance with already registered drugs. (xiii) The registered drugs shall conform to the specifications of pharmacopoeial reference as provided in the Rules. In case, if the drug is not yet included in any of the pharmacopoeia, it shall conform to the *innovator’s company specifications as approved by the regulatory authority of any reference countries specified by the Registration Board subject to compliance of Drug (Specifications) Rules, 1978. The innovator’s specifications, however, are valid only till inclusion of the product in the official pharmacopoeia of reference countries as specified by the Registration Board. (xiv) WHO specification shall be followed for biological products, vaccines or other drugs where such products are not included in official pharmacopeia of reference countries as specified by the Registration Board. (xv) Other conditions as contained under the Drugs Act, 1976 and rules framed there under including, stability studies shall be strictly adhered to, vyyyVy or-ti-Ain Arshia Ch. ZeGhan Nazir Bajar Dr. Muhammad Fakbrujidin Aamir Deputy Director (Reg-1) _Addifional Director (PE&RY/ Director (PE & R)/ Secretary Registration Board Chairman Registratigh Board Copy for information to:- 1. Provincial Health Secretaries of Khyber Pakhtunkhwa, Punjab, Sindh, Balochistan, Gilgit Baltistan, Azad Jammu Kashmir & Senior Drug Inspector, Islamabad. 2. Master file. 3. Reference letter No.F.3-4/2022-Reg-l (M-321) Islamabad, the 1O** July, 2023. Through E-Office 1. The Additional Director, DRAP, Peshawar (with the request to provide copy of this letter to area FID.) 2. The Deputy Director (Costing & Pricing), DRAP, Islamabad. 3. The Deputy Director (RRR), DRAP, Islamabad. 4.-“In-charge (DMC), DRAP, Islamabad.